International Journal of Nursing Studies 52 (2015) 1029–1041
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A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial Xingjuan Tao, Susan Ka Yee Chow *, Frances Kam Yuet Wong School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 23 January 2015 Received in revised form 16 March 2015 Accepted 18 March 2015
Background: Patients on maintenance hemodialysis suffer from diminished physical health. Directly supervised exercise programs have been shown to be effective at improving physical function and optimizing well-being. However, nurses seldom include an exercise intervention in the care plan for hemodialysis patients. Objectives: The purpose of this study was to examine the effects of a 12-week nurse-led case management program on home exercise training for hemodialysis patients. Design: The study was a randomized, two-parallel group trial. Settings: Hemodialysis units in two tertiary hospitals in Nanjing, mainland China. Participants: One hundred and thirteen adult patients who have been in stable condition while on dialysis treatment for more than 3 months were recruited and randomly assigned to either the study group (n = 57) or the control group (n = 56). Methods: Both groups underwent a brief weekly in-center exercise training session before their dialysis sessions for the first 6 weeks. The study group received additional nurse case management weekly for the first 6 weeks and biweekly for the following 6 weeks. The intervention was to facilitate patients in performing regular exercise at home. Outcome measures, including gait speed, 10-repetition sit-to-stand performance, and quality of life were collected at baseline, and at 6 and 12 weeks into the program. Results: The results revealed that patients in the study group demonstrated greater increases in normal gait speed [F(1,111) = 4.42, p = 0.038] than the control group. For the study group, a mean increase of 12.02 (3.03) centimeters/second from baseline to week 12 was found. With regard to the fast gait speed, there was a marginally significant betweengroup effect [F(1,111) = 3.93, p = 0.050]. The study group showed a mean improvement of 11.08 (3.32) cm/s, from baseline to week 12. Patients from both groups showed improvements in their 10-repetition sit-to-stand performance. The between-group differences approached significance [F(1,111) = 3.92, p = 0.050], with the study group showed greater improvement than the control group. The time taken by the patients in the study group to complete the 10-STS test increased by 5.75 (3.88) s from baseline to week 12. Significant improvements in quality of life across three time points were found only in the study group. Conclusions: Home exercise using a nurse-led case management approach is practical and effective in improving the physical function and self-perceived health of stable hemodialysis patients. ß 2015 Elsevier Ltd. All rights reserved.
Keywords: Home exercise Hemodialysis Physical activity Functional status Quality of life
* Corresponding author at: School of Nursing, The Hong Kong Polytechnic University, Hunghom, Kowloon, Hong Kong, China. Tel.: +852 27666775; fax: +852 23649663. E-mail addresses: [email protected], [email protected] (S.K.Y. Chow). http://dx.doi.org/10.1016/j.ijnurstu.2015.03.013 0020-7489/ß 2015 Elsevier Ltd. All rights reserved.
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What is already known about the topic? Direct supervised exercise training programs have been shown to be effective at improving the physical function and quality of life of dialysis patients. Healthcare providers in dialysis centers rarely encourage patients to be active, and the majority of patients undergoing hemodialysis treatment are leading sedentary lives. Nurses are well positioned to help patients engage in exercise, due to their prolonged and sustained contacts with patients. What this paper adds Home exercise with a nurse-led case management approach is safe and effective at improving the physical function and perceived well-being of hemodialysis patients. Trained clinical nurses are capable of delivering home exercise for stable dialysis patients. The nurse-led home exercise program can easily be incorporated into daily clinical practice. 1. Introduction Patients on maintenance hemodialysis, regardless of age, suffer from impaired physical function (Kaysen et al., 2011; Matsuzawa et al., 2014; Painter and Roshanravan, 2013), which subsequently results in unemployment (van Manen et al., 2001), dependence in activities of daily living, disability (Altintepe et al., 2006), and an increased risk of hospitalization and mortality (Peng et al., 2010). Being physically inactive has been recognized as an important contributor to deterioration in the physical functioning of the dialysis population (Painter et al., 1999). Both diminished physical function and reduced daily physical activity have been associated with adverse clinical outcomes in observational studies of patients on hemodialysis treatment (Johansen et al., 2013; Matsuzawa et al., 2012; Tentori et al., 2010). Systematic reviews and meta-analyses have shown that exercise, as a subcategory of physical activity, is effective at improving the physical function, depression, and healthrelated quality of life (HRQOL) of patients on hemodialysis (Cheema and Singh, 2005; Heiwe and Jacobson, 2011; Ouzouni et al., 2009; Segura-Orti et al., 2009). Meanwhile, K/DOQI clinical practice guidelines state that ‘‘all dialysis patients should be counseled and regularly encouraged by nephrologists and dialysis staff to increase their level of physical activity’’ (K/DOQI Workgroup, 2005). Unfortunately, the various observational studies have consistently shown that the majority of dialysis patients lead sedentary lives (Avesani et al., 2012; Kim et al., 2014; Longenecker et al., 2002; O’Hare et al., 2003). Moreover, exercise programs are not commonly implemented in most hemodialysis facilities (Painter et al., 2014). Both clinical investigations and qualitative interviews revealed a range of barriers to participating in exercise and implementing exercise programs. From the perspective of patients, a lack of exercise-related knowledge, a fear of
injuries, experiencing symptoms of debilitation, a low capacity for exercise, and a lack of motivation are some common barriers to engaging in exercise (Delgado and Johansen, 2012; Heiwe and Tollin, 2012; Kontos et al., 2007; Painter et al., 2004). From the perspective of dialysis facilities, resource restrictions are the major concern, such as a lack of professionals to supervise exercise programs, the limited involvement of health care providers, and a lack of financial support (Bennett et al., 2010). The lack of exercise equipment is another barrier to implementing exercise programs in clinical practice (Kontos et al., 2007). Nurse case management is described as the strategies and process of providing health care to high-risk populations, including those in acute care, long-term care, and community settings (Lamb, 1992). A systematic review and meta-analysis showed that nurse case management using complex interventions can preserve the physical function and independence of elderly people living in the community (Beswick et al., 2008). Through the multidisciplinary coordination of care, individualized exercise programs, counseling, and continuous monitoring, case management offers opportunities to provide interventions to overcome the obstacles that patients face to participating in exercise. The meta-analyses and reviews, which include studies of different chronic disease groups, have demonstrated the effects of nurse case management on improving functionality, quality of life, treatment adherence, self-care ability, and patient satisfaction; as well as on decreasing service use and costs (Latour et al., 2007; Sutherland and Hayter, 2009; Welch et al., 2010). In the chronic kidney disease population, the results from previous randomized controlled trials support the argument that nurse case management is effective at improving clinical and patient outcomes, such as fewer hospitalizations (Dixon et al., 2011; Steele et al., 2007) and improvements in quality of life and patient satisfaction (Chow and Wong, 2010; Li et al., 2014; Wong et al., 2010). The self-efficacy levels and self-management capacities of patients were found to have increased after they received support from a nurse-led multidisciplinary team (Su et al., 2009; Wong et al., 2010). To address the resource challenges faced by dialysis facilities, home exercise, with its fewer resource requirements, is a possible alternative. It is recommended as a way to easily incorporate physical activity into an individual’s daily life (Delgado and Johansen, 2012; Kontos et al., 2007). Exercising at home gives patients on dialysis the flexibility to adjust exercise schedules to accommodate their fatigue levels (Horigan, 2012). Preliminary studies have revealed that home and center-based exercise led to equal gains in clinical and patient outcomes, but that home exercise was more likely to be sustained (Dalal et al., 2010; Malagoni et al., 2008). Exercise should not be regarded as the exclusive domain of physiotherapists. The whole nephrology team should advise, encourage, and help patients to engage in physical activity, and regard these activities as an integral part of the patient care plan (Smith and Burton, 2012). Nurses have the obligation to help patients reach their full life potential, and are more likely than physicians to discuss patient outcomes with both patients and family
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Fig. 1. Study design.
members (Coulter and Ellins, 2007). They are well positioned to help patients take up exercise and engage in home exercise programs, due to their prolonged and sustained contact with the patients and their family members. Although exercise has been shown to be effective at improving the physical function and quality of life of hemodialysis patients, studies investigating the effects of home exercise on physical function (Koh et al., 2009; Malagoni et al., 2008) have not provided sound evidence of its benefits for this group of patients. Thus, further studies in this area are warranted. Although the findings of nurse case management for patients with chronic kidney disease are promising; the results cannot be generalized to home exercise programs for hemodialysis patients. To our knowledge, the effects of a nurse-led exercise program adopting a case management approach have not been previously evaluated for hemodialysis patients. 2. Objective and hypotheses The objective of this study is to examine the effects of a nurse-led case management program on home exercise training in improving the physical function and quality of life of hemodialysis patients. The hypotheses are: Patients in the study group that received nurse case management in home exercise will show higher physical functioning than those in the control group that received only brief in-center group exercise. Patients in the study group that were provided with nurse case management of home exercise will have better health-related quality of life than the control group that received only brief in-center group exercise. 3. Methods 3.1. Study design This study was a randomized, two-parallel group trial. All eligible participants were randomly assigned to either
the study group or the control group, at a ratio of 1:1, to receive the corresponding interventions. The intervention was 12 weeks in duration. Data were collected at three time points: at the baseline before the intervention, at week 6, and at week 12. The second time point for data collection was based on the study by Chow and Wong (2010) in which nurse case management was shown to be effective for peritoneal dialysis patients after follow ups for 6 consecutive weeks. Other studies indicated that improvements in the physical function of hemodialysis patients occurred after at least 3 months of exercise training (Cheema and Singh, 2005; Heiwe and Jacobson, 2011); the third data collection point was therefore determined to be at week 12 (see Fig. 1). 3.2. Study settings The study was conducted from January to December 2013 in the hemodialysis centers of two tertiary hospitals in Nanjing, the capital of Jiangsu province, China. The city had an estimated dialysis population of 1603 adults in 2009 (Nanjing Daily, 2009). The first center was one of the first dialysis centers in Jiangsu, and has approximately 250 patients. The second center is the largest dialysis center in Jiangsu and provides hemodialysis services to about 500 patients. The dialysis practices in the two centers are similar. There are two fixed shifts of hemodialysis treatments from Monday to Saturday – the morning and afternoon shifts. No similar exercise program was provided to patients before and during the study period. 3.3. Participants Patients were eligible to participate if they: were over the age of 18, were able to communicate in Chinese and provide consent, were able to ambulate without assistance, were on hemodialysis treatment for more than 3 months, undergoing dialysis three times per week, had a Kt/V of greater than 1.2, and had achieved a hemoglobin level of greater than 80 g/L. Exclusion criteria included patients who: had been diagnosed with a mental illness, were in unstable physical condition, were suffering from a
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Fig. 2. The interventions for the trial groups.
severe musculoskeletal disease that might impede their participation in exercise, had severe hearing loss that was affecting their ability to communicate, or were already performing 30 min of regular exercise per day, 3 days per week for the past 3 months. The patients were assessed by the physician in-charge to ensure that they were able to perform the recommended exercise. The nurses assessed the patients’ hearing abilities to determine whether the impairment affected communication. Those patients who met the criteria for eligibility were invited to participate in the study. 3.4. Randomization and blinding As the number of hemodialysis patients in the two study sites was not equal, at approximately 250 and 500, respectively, two sets of randomization sequences were generated in a 1:2 ratio. The randomization sequence was generated from the website:www.randomization.com (Haahr, 1998). Block randomization was adopted to balance the sample size of the groups. Each sequence set was generated via block randomization, with random block sizes of 2, 4, and 6. The random assignments were then sealed and stapled in thick, opaque, consecutively numbered envelopes before the data were collected. Those envelopes were locked up and only the person responsible for allocation could access the assignments. Participants who completed the baseline data evaluation were randomly assigned to either the study group or the control group according to the randomization sequence generated by the researcher. The envelopes were opened sequentially, from the lowest to the next highest numbered envelope. The data collectors were blinded to the random assignments throughout the whole study period. 3.5. Interventions The intervention consisted of two components: brief incenter group exercise training and nurse case management
of home exercise. The control group received group exercise only. The study group was exposed to both components. The interventions for the two trial groups are shown in Fig. 2. 3.5.1. Brief in-center group exercise training The center-based group exercise training was delivered weekly for 6 consecutive weeks by the researcher to a group of four to six patients before dialysis sessions. Each session lasted approximately 20 minutes, with the researcher demonstrating the exercises according to the exercise protocol. The exercise consisted of flexibility and strength exercises. Flexibility exercises use gentle muscle stretching and slow movements to help the joints work smoothly. Strengthening exercises use resistance, such as elastic bands or one’s own body weight to make muscles work harder (Painter, 1999). The participants were instructed to start exercising slowly and progress gradually according to their physical abilities. They were told to stop exercising when they experienced symptoms, such as dizziness, blurred vision, chest pains, dyspnea, leg cramps, or any sort of discomfort. The group exercise protocol was developed based on the publication ‘‘Exercise: A Guide for the People on Dialysis’’ (Painter, 1999). The contents have been validated in a U.S. population (Painter et al., 2000). The research team translated the contents after obtaining permission from the publisher and author. The translated exercise program was then validated by a panel of experts for translation accuracy, feasibility, and safety issues for implementation on Chinese hemodialysis patients. The panel members were required to provide a document containing a written summary that clearly indicated the translation equivalence, and to comment on the quality of the exercise protocol and whether revisions were required. The feasibility of the exercise protocol was further determined in the pilot study. Each participant was given a booklet illustrating the exercises. The investigator demonstrated the exercise to the patients and they were required to
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perform a return demonstration. The pilot study showed that patients were able to manage the various exercises in the group exercise session as indicated in the protocol. 3.5.2. Nurse case management The nurse case management was aimed at individually helping patients to perform regular exercise at home after participating in the group exercise. Nine nurse–patient clinical interview sessions were offered to the study group during the dialysis sessions – weekly for the first 6 weeks and biweekly for the following 6 weeks. The first session lasted for about 20-30 minutes, and each follow-up session for around 15 minutes, depending on the needs of the individual patients. The interviews were conducted within the first two hours of the dialysis treatment to avoid possible discomfort related to the dialysis treatment towards the end of the session (Caplin et al., 2011). The case management protocol was developed based on Pender’s health promotion model (Pender et al., 2011). Nurse–patient clinical interviews are an essential feature of the protocol. The interviews focused on the barriers to exercising, identifying, and solving problems, the mutual setting of goals on home exercise, negotiating an action plan, and monitoring exercise safety. Along with flexibility and strength exercises, the patients were advised to initiate home exercise, including engaging in aerobic exercises such as brisk walking, jogging, or cycling, according to their preference. Patients were instructed to progress gradually to the recommended exercise levels: flexibility exercises daily, strength exercises twice a week, and 30 minutes of aerobic exercise at least three times per week. Patients were instructed to keep exercise logs for self-monitoring and nurse follow-ups. Referrals were also made as needed. If the participants experienced symptomatic hypertension, they were referred to the physician in charge for further assessment. 3.5.3. Preparation of the interventionists The interventionists in this study consisted of the researcher and the clinical nurses. The researcher delivered a brief session of center-based group exercise training across the study sites to maximize the consistency of the implementation of the intervention. A physiotherapist with 24 years of experience in clinical rehabilitation provided the researcher with supervision and coaching on the exercise protocol. The researcher learned and practiced the exercise according to the protocol under the supervision of the physiotherapist, and return demonstrations were performed to ensure that the researcher was able to teach exercise competently and safely. To maintain safety precautions during the course of the training, the researcher also discussed exercise prescriptions and exercise safety with the physiotherapist, who maintained close contact with the researcher throughout the entire study period. Eight clinical nurses from two study sites underwent 12 hours of structured training on how to implement the case management home exercise program. The training program consisted of four components: an introduction to the study, the exercise program, interview skills, and nurse case management. The case managers were required to go
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through all of the training sessions and pass the exit examination to ensure competence in the implementation of the interventions and consistency in the nurse case management. 3.5.4. Intervention fidelity Support materials, including a patient exercise booklet and an intervention manual, were distributed to each case manager. During the process of implementing the program, an intervention checklist that had been developed in accordance with the protocol was used to help nurses perform self-monitoring. The researcher reviewed the interview records and randomly attended the interview sessions to evaluate the case managers’ performance. Meetings to discuss special cases were conducted monthly to discuss the problems that had been encountered and the potential solutions. The researcher provided feedback on the quality of the intervention based on an inspection of the case records and observations of the interview sessions. 3.6. Ethical considerations The study was approved by the Human Subjects Ethical Sub-committee of the affiliated university and by the hospitals where the program was carried out. All of the participants were informed of the purpose, procedures, and confidentiality of the study. It was made clear to them that their participation was voluntary and that they could withdraw from the study at any time without penalty. All of the subjects who participated in the study gave their signed consent before the baseline data were collected. 3.7. Outcomes measurements and tools 3.7.1. Primary outcomes Gait speed was regarded as the primary outcome in evaluating the functional improvement of the patients. The patients were instructed to walk twice along a 10-meter corridor, once at a comfortable speed (normal gait speed) and once at a fast speed (fast gait speed) that the patients could tolerate. The speed of their gait was calculated according to the centimeters completed in 1 second. This measurement has been demonstrated to be effective at detecting changes in the physical function of hemodialysis patients (Headley et al., 2002; Painter et al., 2000), and to have adequate test–retest reliability with an intraclass correlation coefficient (ICC) ranging from 0.90 to 0.98 (van Loo et al., 2004). 3.7.2. Secondary outcomes Standing on a chair is an essential activity for independent daily living. Csuka and McCarty (1985) were the first to describe using the 10-repetition sit-to-stand (10-STS) as a proxy measure for lower-extremity strength. The patients were asked to sit in a 43-cm tall chair without arms, and to rise to a full standing position as quickly as possible with two arms crossed over their chest. The time that it took to finish going from sitting to standing 10 times was recorded. The 10-STS has been accepted as an indicator of the functional status of patients with chronic
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kidney disease (Brodin et al., 2008; Painter et al., 2000) with good test–retest reliability (ICC, 0.88) on the hemodialysis population (Segura-Orti and MartinezOlmos, 2011). It has been adopted as one of the outcome measures for evaluating the effects of different exercise training programs on the hemodialysis population (Headley et al., 2002; Painter et al., 2000; Segura-Orti et al., 2009). Kidney Disease Quality of Life (KDQOL-36TM), a 36-item disease-specific questionnaire, was employed to evaluate the patients’ HRQOL. The questionnaire consists of a 12item Short Form Health Survey (SF-12) as a generic component for quality of life and 24 disease-specific items divided into three subscales: the Symptom and Problems List, the Burden of Kidney Disease, and the Effects of Kidney Disease. The SF-12 scores were aggregated into two component summaries: the physical component summary (PCS) and the mental component summary (MCS). Scores were calculated according to the KDQOL 1.3 Manual for Use and Scoring (Hays et al., 1997). They ranged from 0 to 100, with a higher score indicating a better HRQOL. The Chinese version of the KDQOL-36TM has demonstrated acceptable levels of internal consistency (with a Cronbach’s alpha ranging from 0.69 to 0.78) and test–retest reliability (ICC ranging from 0.70 to 0.86). The construct validity of the Chinese version of the KDQOL-36TM was supported by the convergent validity and known-group validity (Tao et al., 2014). 3.8. Sample size estimation The size of the sample was estimated from the results of the normal gait speed reported by Painter et al. (2000) in a controlled study examining the effects of an exercise program for hemodialysis patients. Based on repeated measures analysis of variance (ANOVA), the total sample size needed to adequately detect between-group differences was determined to be 96, 48 for each group. The design achieved 80% power with a 5% significance level, assuming that the correlation of the repeated measures was 0.8. According to a previous study, a dropout rate of 17% was observed for patients on home exercise (Konstantinidou et al., 2002). With a dropout rate of 17%, a total of 112 subjects were required for the current study. 3.9. Statistical analysis Data analysis was carried out using the Statistical Package for Social Sciences (version 20.0). Descriptive statistics were used to display demographic and clinical information. Repeated measures analysis of variance (ANOVA) was employed to determine the effects of the program on continuous outcome variables with normal distribution. The Friedman test and the Mann–Whitney U test were used for data that were not normally distributed. Bonferroni corrections were used for pairwise comparisons to adjust type I errors. An intention-to-treat analysis was applied to avoid potential biases due to non-random patient drop-outs. Multiple imputation was adopted to handle missing data. All statistical tests were two-tailed, and P < 0.05 was considered statistically significant. Effect
size was estimated by calculating partial eta squared h2p for group comparisons, and Cohen’s d for comparisons of changes in mean over time. For interpretation, the small, moderate, and large effect sizes were defined as h2p < 0:01, 0.01–0.06, and >0.14, respectively; and Cohen’s d < 0.2, 0.2–0.5, and >0.8, respectively (Cohen, 1988). 4. Results Four hundred and sixty-six hemodialysis patients were assessed for eligibility, and 277 of them were excluded. A total of 113 patients were recruited and randomly allocated – 57 to the study group and 56 to the control group. Five patients in the control group and one from the study group discontinued the intervention. Fig. 3 displays the CONSORT flowchart (Moher et al., 2012). 4.1. Baseline demographics and clinical characteristics Table 1 shows that the mean age of the participants was 54.8, ranging from 27 to 74 years old. There were more males (52.2%) than females. The majority of the participants were married (82.3%) and not working (92%). Only 7.1% of the participants had received a primary education or below. Primary education refers to Grade 1 to Grade 6 or elementary school in Western countries. Chronic glomerular nephritis (25.7%) was the major cause of their renal failure. The average duration for dialysis was 84.1 months, with a range of 5–334 months. Subjects with no reported co-morbidities constituted 26.3% of the sample. 4.2. Effects of the nurse-led case management of home exercise 4.2.1. Primary outcomes With regard to the normal gait speed, as shown in Table 2, the repeated measures ANOVA indicated a significant between-group effect, with the study group experiencing greater improvements than the control group [F(1,111) = 4.42, p = 0.038, h2p ¼ 0:038]. With regard to the within-group effects, a significant improvement in the normal gait speed across the three time points was observed only in the study group [F(2,112) = 9.53, p < 0.001, h2p ¼ 0:145], with a significant mean increase (p = 0.001, Cohen’s d = 0.45) of 12.02 (3.03) centimeters per second (cm/s) from baseline to week 12. The interaction effect between groups and time points was also significant, indicating that the increase for the groups was different at the three time points [F(1.88,208.09) = 3.30, p = 0.042, partial eta squared = 0.029]. For the fast gait speed, there was a marginally significant between-group effect (F(1,111) = 3.93, p = 0.05, partial eta squared = 0.034), with the study group demonstrating greater improvement in the repeated measures ANOVA analysis. A significant interaction effect between the two groups and three time points was observed [F(1.81,201.26) = 4.21, p = 0.019, h2p ¼ 0:037]. A significant within-group difference was only noted in the study group [F(1.66,92.95) = 8.08, p = 0.001, h2p ¼ 0:126], with a significant mean improvement (p = 0.005, Cohen’s d = 0.29) of 11.08 (3.32) cm/s, from baseline to week 12.
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Enrollment
Assessed for eligibility (n = 466) Excluded (n = 353) Not meeting inclusion criteria (n = 277) Refused to participate (n = 76)
Allocated to intervention (n = 56)
Received allocated intervention (n = 57)
Received allocated intervention (n = 56)
Did not receive allocated intervention (n = 0)
Did not receive allocated intervention (n = 0)
Lost to follow up (n =0)
Lost to follow up (n = 1) (Reason: transfer to another hospital)
Follow up
Allocated to intervention (n = 57)
Discontinued intervention (n =1) (Reason: catheter infection)
Analysis
Allocation
Randomized (n = 113)
Analyzed (n = 57)
Analyzed (n = 56)
Excluded from analysis (n = 0)
Excluded from analysis (n = 0)
Discontinued intervention (n = 4) (Reasons: 1 ankle injury, 1fever, 2 withdraw: not interested)
Fig. 3. Flowchart of the participants throughout the trial.
4.3. Secondary outcomes 4.3.1. 10-STS performance For the 10-STS performance, the repeated measures ANOVA revealed that the between-group differences approached significance [F(1,111) = 3.92, p = 0.050], with the increases in the study group being greater than those in the control group. A significant interaction effect [F(1.65,182.66) = 6.11, p = 0.005] was also observed, suggesting that the trends of increase for the two groups were different over time. Significant within-group increases across the three time points were noted for both the study [F(2,112) = 101.99, p < 0.001] and control groups [F(1.47,80.76) = 21.22, p < 0.001]. The time taken by the
patients in the study group to complete the 10-STS test decreased from 19.78 (6.57) to 14.03 (4.97) seconds, from baseline to week 12, p < 0.001. The mean actual improvement was 5.75 (3.88) s. A similar trend was noted in the control group with the mean actual improvement of 4.93 (+13.88) s. However, the study group patients took less time than the control group patients to complete the 10-STS after finishing the program (F(1,111) = 8.72, p = 0.004). For details, please refer to Table 3. 4.3.2. HRQOL For HRQOL, the result of the Friedman tests showed that significant within-group effects in the study group were
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Table 1 Baseline demographic and clinical characteristics. Characteristics Age (years; M, SD) Gender (male) Marital status Married Single Divorced/widowed Education level Primary or below Secondary Tertiary or above Employment Full time Part time Retired Homemaker Others Insurance Government insurance Self-pay Financial status More than sufficient Barely sufficient Insufficient Extremely insufficient Primary cause for renal failure Chronic glomerular nephritis Hypertension Diabetes Gout Unknown Others Comorbidity No other diseases Hypertension Cardiac disease Diabetes Respiratory disease Others Hemodialysis duration (months; M, SD) Hemoglobin (g/L; M, SD)
Study (n = 57)
Control (n = 56)
Total (n = 113)
53.02 (11.62) 29 (50.9%)
56.68 (9.67) 30 (53.6%)
54.83 (10.81) 59 (52.2%)
42 (73.7%) 7 (12.3%) 8 (14%)
51 (91.1%) 0 (0.0%) 5 (8.9%)
93 (82.3%) 7 (6.2%) 13 (11.5%)
4 (7.0%) 43 (75.4%) 10 (17.5%)
4 (7.2%) 39 (69.6%) 13 (23.2%)
8 (7.1%) 82 (72.5%) 23 (20.4%)
4 1 36 6 10
2 2 45 2 5
6 3 81 8 15
(7.0%) (1.8%) (63.2%) (10.5%) (17.5%)
(3.6%) (3.6%) (80.4%) (3.6%) (8.9%)
(5.3%) (2.7%) (71.7%) (7.1%) (13.3%)
47 (82.5%) 10 (17.5%)
52 (91.0%) 5 (9.0%)
98 (86.7%) 15 (13.3%)
9 27 12 9
(15.8%) (47.4%) (21.1%) (15.8%)
8 37 9 2
(14.3%) (66.1%) (16.1%) (3.6%)
17 64 21 11
(15.0%) (56.6%) (18.6%) (9.7%)
13 (22.8%) 10 (17.5%) 7(12.3%) 9 (15.8%) 13 (22.8%) 5(8.8%)
16 16 9 5 6 4
(28.6%) (28.6%) (16.1%) (8.9%) (10.7%) (7.2%)
29 26 16 14 19 9
(25.7%) (23.0%) (14.2%) (12.4%) (16.8%) (8.0%)
16 (23.5%) 30 (44.1%) 15 (22.1%) 5 (7.4%) 0 (0%) 2 (2.9%) 83.46 (61.37) 105.18 (12.00)
19 (29.2%) 26 (40.0%) 11 (16.9%) 3 (4.6%) 1 (1.5%) 5 (7.7%) 84.70 (70.55) 106.94 (13.53)
35 (26.3%) 56 (42.1%) 26 (19.5%) 8 (6.0%) 1 (0.7%) 7 (5.3%) 84.07 (65.78) 106.05 (12.74)
Note: some participants suffered more than one disease, causing the number of the comorbidities greater than the number of patients for each trial group. M = mean; SD = standard deviation.
demonstrated for all kidney disease-specific domains. The scores on Symptom and Problem List increased over time, with x2 (2, n = 57) = 7.92, p = 0.019. A post hoc analysis indicated a significant improvement in the Symptom and Problem List from week 6 to week 12, with z = 2.53, p = 0.011. With regard to the Burden of Kidney Disease subscale, a statistically significant within-group effect for the study group across the three time points was found, with x2 (2, n = 57) = 9.31, p = 0.01. The patients’ perception of the Burden of Kidney Disease decreased from baseline to week 12, with z = 2.51, p = 0.012. With regard to the Effects of Kidney Disease subscale, a significant withingroup effect was likewise only observed in the study group, with x2 (2, n = 57) = 11.08, p = 0.004. No significant between-group differences were noted for any of the kidney disease-specific subscales at either time point in the Mann–Whitney U tests. With regard to scores on the PCS and MCS subscales, neither a between-group nor a within-group effect was found. For details, please refer to Table 3.
5. Discussion The results of the study indicated that the 12-week program on nurse case management of home exercise is effective at improving the physical function of patients and further improving their overall quality of life. 5.1. Effectiveness of the program on physical function The significant improvements in gait speed and 10-STS performance support the claim that the 12-week nurse case management program on home exercise is effective at enhancing physical function. For the study group, a mean increase of 12.01 cm/s (equivalent to 0.12 m/s) on the normal gait speed from baseline to week 12 was found. Previous studies suggested that a change of 0.1 m/s on the normal gait speed constitutes substantial meaningful change (Chui et al., 2012); indicating that the improvements on gait speed in the current study were both statistically and clinically significant.
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Table 2 Comparisons of physical performance tests by groups over three time points. Physical performance tests
Baseline n
Mean (SD)
At 6 weeks
At 12 weeks
Between Groups
Within groups
Interaction effect
Mean (SD)
Mean (SD)
F (p-value)
F (p-value) [A,B,C]
F (p-value)
Normal gait speed (cm/s)
4.422 (*0.038)
Study
57
120.88 (25.46)
128.44 (24.00)
132.90 (27.89)
Control
56
116.65 (27.53)
119.19 (23.44)
119.38 (23.18)
F (p-value) Fast gait speed (cm/s)
4.302 (*0.040)
0.719 (0.398)
57
167.57 (37.92)
174.54 (35.54)
178.65 (37.66)
Control
56
159.71 (40.40)
161.36 (37.96)
159.73 (35.85)
Control
9.528 (*
Contents lists available at ScienceDirect
International Journal of Nursing Studies journal homepage: www.elsevier.com/ijns
A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial Xingjuan Tao, Susan Ka Yee Chow *, Frances Kam Yuet Wong School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China
A R T I C L E I N F O
A B S T R A C T
Article history: Received 23 January 2015 Received in revised form 16 March 2015 Accepted 18 March 2015
Background: Patients on maintenance hemodialysis suffer from diminished physical health. Directly supervised exercise programs have been shown to be effective at improving physical function and optimizing well-being. However, nurses seldom include an exercise intervention in the care plan for hemodialysis patients. Objectives: The purpose of this study was to examine the effects of a 12-week nurse-led case management program on home exercise training for hemodialysis patients. Design: The study was a randomized, two-parallel group trial. Settings: Hemodialysis units in two tertiary hospitals in Nanjing, mainland China. Participants: One hundred and thirteen adult patients who have been in stable condition while on dialysis treatment for more than 3 months were recruited and randomly assigned to either the study group (n = 57) or the control group (n = 56). Methods: Both groups underwent a brief weekly in-center exercise training session before their dialysis sessions for the first 6 weeks. The study group received additional nurse case management weekly for the first 6 weeks and biweekly for the following 6 weeks. The intervention was to facilitate patients in performing regular exercise at home. Outcome measures, including gait speed, 10-repetition sit-to-stand performance, and quality of life were collected at baseline, and at 6 and 12 weeks into the program. Results: The results revealed that patients in the study group demonstrated greater increases in normal gait speed [F(1,111) = 4.42, p = 0.038] than the control group. For the study group, a mean increase of 12.02 (3.03) centimeters/second from baseline to week 12 was found. With regard to the fast gait speed, there was a marginally significant betweengroup effect [F(1,111) = 3.93, p = 0.050]. The study group showed a mean improvement of 11.08 (3.32) cm/s, from baseline to week 12. Patients from both groups showed improvements in their 10-repetition sit-to-stand performance. The between-group differences approached significance [F(1,111) = 3.92, p = 0.050], with the study group showed greater improvement than the control group. The time taken by the patients in the study group to complete the 10-STS test increased by 5.75 (3.88) s from baseline to week 12. Significant improvements in quality of life across three time points were found only in the study group. Conclusions: Home exercise using a nurse-led case management approach is practical and effective in improving the physical function and self-perceived health of stable hemodialysis patients. ß 2015 Elsevier Ltd. All rights reserved.
Keywords: Home exercise Hemodialysis Physical activity Functional status Quality of life
* Corresponding author at: School of Nursing, The Hong Kong Polytechnic University, Hunghom, Kowloon, Hong Kong, China. Tel.: +852 27666775; fax: +852 23649663. E-mail addresses: [email protected], [email protected] (S.K.Y. Chow). http://dx.doi.org/10.1016/j.ijnurstu.2015.03.013 0020-7489/ß 2015 Elsevier Ltd. All rights reserved.
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What is already known about the topic? Direct supervised exercise training programs have been shown to be effective at improving the physical function and quality of life of dialysis patients. Healthcare providers in dialysis centers rarely encourage patients to be active, and the majority of patients undergoing hemodialysis treatment are leading sedentary lives. Nurses are well positioned to help patients engage in exercise, due to their prolonged and sustained contacts with patients. What this paper adds Home exercise with a nurse-led case management approach is safe and effective at improving the physical function and perceived well-being of hemodialysis patients. Trained clinical nurses are capable of delivering home exercise for stable dialysis patients. The nurse-led home exercise program can easily be incorporated into daily clinical practice. 1. Introduction Patients on maintenance hemodialysis, regardless of age, suffer from impaired physical function (Kaysen et al., 2011; Matsuzawa et al., 2014; Painter and Roshanravan, 2013), which subsequently results in unemployment (van Manen et al., 2001), dependence in activities of daily living, disability (Altintepe et al., 2006), and an increased risk of hospitalization and mortality (Peng et al., 2010). Being physically inactive has been recognized as an important contributor to deterioration in the physical functioning of the dialysis population (Painter et al., 1999). Both diminished physical function and reduced daily physical activity have been associated with adverse clinical outcomes in observational studies of patients on hemodialysis treatment (Johansen et al., 2013; Matsuzawa et al., 2012; Tentori et al., 2010). Systematic reviews and meta-analyses have shown that exercise, as a subcategory of physical activity, is effective at improving the physical function, depression, and healthrelated quality of life (HRQOL) of patients on hemodialysis (Cheema and Singh, 2005; Heiwe and Jacobson, 2011; Ouzouni et al., 2009; Segura-Orti et al., 2009). Meanwhile, K/DOQI clinical practice guidelines state that ‘‘all dialysis patients should be counseled and regularly encouraged by nephrologists and dialysis staff to increase their level of physical activity’’ (K/DOQI Workgroup, 2005). Unfortunately, the various observational studies have consistently shown that the majority of dialysis patients lead sedentary lives (Avesani et al., 2012; Kim et al., 2014; Longenecker et al., 2002; O’Hare et al., 2003). Moreover, exercise programs are not commonly implemented in most hemodialysis facilities (Painter et al., 2014). Both clinical investigations and qualitative interviews revealed a range of barriers to participating in exercise and implementing exercise programs. From the perspective of patients, a lack of exercise-related knowledge, a fear of
injuries, experiencing symptoms of debilitation, a low capacity for exercise, and a lack of motivation are some common barriers to engaging in exercise (Delgado and Johansen, 2012; Heiwe and Tollin, 2012; Kontos et al., 2007; Painter et al., 2004). From the perspective of dialysis facilities, resource restrictions are the major concern, such as a lack of professionals to supervise exercise programs, the limited involvement of health care providers, and a lack of financial support (Bennett et al., 2010). The lack of exercise equipment is another barrier to implementing exercise programs in clinical practice (Kontos et al., 2007). Nurse case management is described as the strategies and process of providing health care to high-risk populations, including those in acute care, long-term care, and community settings (Lamb, 1992). A systematic review and meta-analysis showed that nurse case management using complex interventions can preserve the physical function and independence of elderly people living in the community (Beswick et al., 2008). Through the multidisciplinary coordination of care, individualized exercise programs, counseling, and continuous monitoring, case management offers opportunities to provide interventions to overcome the obstacles that patients face to participating in exercise. The meta-analyses and reviews, which include studies of different chronic disease groups, have demonstrated the effects of nurse case management on improving functionality, quality of life, treatment adherence, self-care ability, and patient satisfaction; as well as on decreasing service use and costs (Latour et al., 2007; Sutherland and Hayter, 2009; Welch et al., 2010). In the chronic kidney disease population, the results from previous randomized controlled trials support the argument that nurse case management is effective at improving clinical and patient outcomes, such as fewer hospitalizations (Dixon et al., 2011; Steele et al., 2007) and improvements in quality of life and patient satisfaction (Chow and Wong, 2010; Li et al., 2014; Wong et al., 2010). The self-efficacy levels and self-management capacities of patients were found to have increased after they received support from a nurse-led multidisciplinary team (Su et al., 2009; Wong et al., 2010). To address the resource challenges faced by dialysis facilities, home exercise, with its fewer resource requirements, is a possible alternative. It is recommended as a way to easily incorporate physical activity into an individual’s daily life (Delgado and Johansen, 2012; Kontos et al., 2007). Exercising at home gives patients on dialysis the flexibility to adjust exercise schedules to accommodate their fatigue levels (Horigan, 2012). Preliminary studies have revealed that home and center-based exercise led to equal gains in clinical and patient outcomes, but that home exercise was more likely to be sustained (Dalal et al., 2010; Malagoni et al., 2008). Exercise should not be regarded as the exclusive domain of physiotherapists. The whole nephrology team should advise, encourage, and help patients to engage in physical activity, and regard these activities as an integral part of the patient care plan (Smith and Burton, 2012). Nurses have the obligation to help patients reach their full life potential, and are more likely than physicians to discuss patient outcomes with both patients and family
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Fig. 1. Study design.
members (Coulter and Ellins, 2007). They are well positioned to help patients take up exercise and engage in home exercise programs, due to their prolonged and sustained contact with the patients and their family members. Although exercise has been shown to be effective at improving the physical function and quality of life of hemodialysis patients, studies investigating the effects of home exercise on physical function (Koh et al., 2009; Malagoni et al., 2008) have not provided sound evidence of its benefits for this group of patients. Thus, further studies in this area are warranted. Although the findings of nurse case management for patients with chronic kidney disease are promising; the results cannot be generalized to home exercise programs for hemodialysis patients. To our knowledge, the effects of a nurse-led exercise program adopting a case management approach have not been previously evaluated for hemodialysis patients. 2. Objective and hypotheses The objective of this study is to examine the effects of a nurse-led case management program on home exercise training in improving the physical function and quality of life of hemodialysis patients. The hypotheses are: Patients in the study group that received nurse case management in home exercise will show higher physical functioning than those in the control group that received only brief in-center group exercise. Patients in the study group that were provided with nurse case management of home exercise will have better health-related quality of life than the control group that received only brief in-center group exercise. 3. Methods 3.1. Study design This study was a randomized, two-parallel group trial. All eligible participants were randomly assigned to either
the study group or the control group, at a ratio of 1:1, to receive the corresponding interventions. The intervention was 12 weeks in duration. Data were collected at three time points: at the baseline before the intervention, at week 6, and at week 12. The second time point for data collection was based on the study by Chow and Wong (2010) in which nurse case management was shown to be effective for peritoneal dialysis patients after follow ups for 6 consecutive weeks. Other studies indicated that improvements in the physical function of hemodialysis patients occurred after at least 3 months of exercise training (Cheema and Singh, 2005; Heiwe and Jacobson, 2011); the third data collection point was therefore determined to be at week 12 (see Fig. 1). 3.2. Study settings The study was conducted from January to December 2013 in the hemodialysis centers of two tertiary hospitals in Nanjing, the capital of Jiangsu province, China. The city had an estimated dialysis population of 1603 adults in 2009 (Nanjing Daily, 2009). The first center was one of the first dialysis centers in Jiangsu, and has approximately 250 patients. The second center is the largest dialysis center in Jiangsu and provides hemodialysis services to about 500 patients. The dialysis practices in the two centers are similar. There are two fixed shifts of hemodialysis treatments from Monday to Saturday – the morning and afternoon shifts. No similar exercise program was provided to patients before and during the study period. 3.3. Participants Patients were eligible to participate if they: were over the age of 18, were able to communicate in Chinese and provide consent, were able to ambulate without assistance, were on hemodialysis treatment for more than 3 months, undergoing dialysis three times per week, had a Kt/V of greater than 1.2, and had achieved a hemoglobin level of greater than 80 g/L. Exclusion criteria included patients who: had been diagnosed with a mental illness, were in unstable physical condition, were suffering from a
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Fig. 2. The interventions for the trial groups.
severe musculoskeletal disease that might impede their participation in exercise, had severe hearing loss that was affecting their ability to communicate, or were already performing 30 min of regular exercise per day, 3 days per week for the past 3 months. The patients were assessed by the physician in-charge to ensure that they were able to perform the recommended exercise. The nurses assessed the patients’ hearing abilities to determine whether the impairment affected communication. Those patients who met the criteria for eligibility were invited to participate in the study. 3.4. Randomization and blinding As the number of hemodialysis patients in the two study sites was not equal, at approximately 250 and 500, respectively, two sets of randomization sequences were generated in a 1:2 ratio. The randomization sequence was generated from the website:www.randomization.com (Haahr, 1998). Block randomization was adopted to balance the sample size of the groups. Each sequence set was generated via block randomization, with random block sizes of 2, 4, and 6. The random assignments were then sealed and stapled in thick, opaque, consecutively numbered envelopes before the data were collected. Those envelopes were locked up and only the person responsible for allocation could access the assignments. Participants who completed the baseline data evaluation were randomly assigned to either the study group or the control group according to the randomization sequence generated by the researcher. The envelopes were opened sequentially, from the lowest to the next highest numbered envelope. The data collectors were blinded to the random assignments throughout the whole study period. 3.5. Interventions The intervention consisted of two components: brief incenter group exercise training and nurse case management
of home exercise. The control group received group exercise only. The study group was exposed to both components. The interventions for the two trial groups are shown in Fig. 2. 3.5.1. Brief in-center group exercise training The center-based group exercise training was delivered weekly for 6 consecutive weeks by the researcher to a group of four to six patients before dialysis sessions. Each session lasted approximately 20 minutes, with the researcher demonstrating the exercises according to the exercise protocol. The exercise consisted of flexibility and strength exercises. Flexibility exercises use gentle muscle stretching and slow movements to help the joints work smoothly. Strengthening exercises use resistance, such as elastic bands or one’s own body weight to make muscles work harder (Painter, 1999). The participants were instructed to start exercising slowly and progress gradually according to their physical abilities. They were told to stop exercising when they experienced symptoms, such as dizziness, blurred vision, chest pains, dyspnea, leg cramps, or any sort of discomfort. The group exercise protocol was developed based on the publication ‘‘Exercise: A Guide for the People on Dialysis’’ (Painter, 1999). The contents have been validated in a U.S. population (Painter et al., 2000). The research team translated the contents after obtaining permission from the publisher and author. The translated exercise program was then validated by a panel of experts for translation accuracy, feasibility, and safety issues for implementation on Chinese hemodialysis patients. The panel members were required to provide a document containing a written summary that clearly indicated the translation equivalence, and to comment on the quality of the exercise protocol and whether revisions were required. The feasibility of the exercise protocol was further determined in the pilot study. Each participant was given a booklet illustrating the exercises. The investigator demonstrated the exercise to the patients and they were required to
X. Tao et al. / International Journal of Nursing Studies 52 (2015) 1029–1041
perform a return demonstration. The pilot study showed that patients were able to manage the various exercises in the group exercise session as indicated in the protocol. 3.5.2. Nurse case management The nurse case management was aimed at individually helping patients to perform regular exercise at home after participating in the group exercise. Nine nurse–patient clinical interview sessions were offered to the study group during the dialysis sessions – weekly for the first 6 weeks and biweekly for the following 6 weeks. The first session lasted for about 20-30 minutes, and each follow-up session for around 15 minutes, depending on the needs of the individual patients. The interviews were conducted within the first two hours of the dialysis treatment to avoid possible discomfort related to the dialysis treatment towards the end of the session (Caplin et al., 2011). The case management protocol was developed based on Pender’s health promotion model (Pender et al., 2011). Nurse–patient clinical interviews are an essential feature of the protocol. The interviews focused on the barriers to exercising, identifying, and solving problems, the mutual setting of goals on home exercise, negotiating an action plan, and monitoring exercise safety. Along with flexibility and strength exercises, the patients were advised to initiate home exercise, including engaging in aerobic exercises such as brisk walking, jogging, or cycling, according to their preference. Patients were instructed to progress gradually to the recommended exercise levels: flexibility exercises daily, strength exercises twice a week, and 30 minutes of aerobic exercise at least three times per week. Patients were instructed to keep exercise logs for self-monitoring and nurse follow-ups. Referrals were also made as needed. If the participants experienced symptomatic hypertension, they were referred to the physician in charge for further assessment. 3.5.3. Preparation of the interventionists The interventionists in this study consisted of the researcher and the clinical nurses. The researcher delivered a brief session of center-based group exercise training across the study sites to maximize the consistency of the implementation of the intervention. A physiotherapist with 24 years of experience in clinical rehabilitation provided the researcher with supervision and coaching on the exercise protocol. The researcher learned and practiced the exercise according to the protocol under the supervision of the physiotherapist, and return demonstrations were performed to ensure that the researcher was able to teach exercise competently and safely. To maintain safety precautions during the course of the training, the researcher also discussed exercise prescriptions and exercise safety with the physiotherapist, who maintained close contact with the researcher throughout the entire study period. Eight clinical nurses from two study sites underwent 12 hours of structured training on how to implement the case management home exercise program. The training program consisted of four components: an introduction to the study, the exercise program, interview skills, and nurse case management. The case managers were required to go
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through all of the training sessions and pass the exit examination to ensure competence in the implementation of the interventions and consistency in the nurse case management. 3.5.4. Intervention fidelity Support materials, including a patient exercise booklet and an intervention manual, were distributed to each case manager. During the process of implementing the program, an intervention checklist that had been developed in accordance with the protocol was used to help nurses perform self-monitoring. The researcher reviewed the interview records and randomly attended the interview sessions to evaluate the case managers’ performance. Meetings to discuss special cases were conducted monthly to discuss the problems that had been encountered and the potential solutions. The researcher provided feedback on the quality of the intervention based on an inspection of the case records and observations of the interview sessions. 3.6. Ethical considerations The study was approved by the Human Subjects Ethical Sub-committee of the affiliated university and by the hospitals where the program was carried out. All of the participants were informed of the purpose, procedures, and confidentiality of the study. It was made clear to them that their participation was voluntary and that they could withdraw from the study at any time without penalty. All of the subjects who participated in the study gave their signed consent before the baseline data were collected. 3.7. Outcomes measurements and tools 3.7.1. Primary outcomes Gait speed was regarded as the primary outcome in evaluating the functional improvement of the patients. The patients were instructed to walk twice along a 10-meter corridor, once at a comfortable speed (normal gait speed) and once at a fast speed (fast gait speed) that the patients could tolerate. The speed of their gait was calculated according to the centimeters completed in 1 second. This measurement has been demonstrated to be effective at detecting changes in the physical function of hemodialysis patients (Headley et al., 2002; Painter et al., 2000), and to have adequate test–retest reliability with an intraclass correlation coefficient (ICC) ranging from 0.90 to 0.98 (van Loo et al., 2004). 3.7.2. Secondary outcomes Standing on a chair is an essential activity for independent daily living. Csuka and McCarty (1985) were the first to describe using the 10-repetition sit-to-stand (10-STS) as a proxy measure for lower-extremity strength. The patients were asked to sit in a 43-cm tall chair without arms, and to rise to a full standing position as quickly as possible with two arms crossed over their chest. The time that it took to finish going from sitting to standing 10 times was recorded. The 10-STS has been accepted as an indicator of the functional status of patients with chronic
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kidney disease (Brodin et al., 2008; Painter et al., 2000) with good test–retest reliability (ICC, 0.88) on the hemodialysis population (Segura-Orti and MartinezOlmos, 2011). It has been adopted as one of the outcome measures for evaluating the effects of different exercise training programs on the hemodialysis population (Headley et al., 2002; Painter et al., 2000; Segura-Orti et al., 2009). Kidney Disease Quality of Life (KDQOL-36TM), a 36-item disease-specific questionnaire, was employed to evaluate the patients’ HRQOL. The questionnaire consists of a 12item Short Form Health Survey (SF-12) as a generic component for quality of life and 24 disease-specific items divided into three subscales: the Symptom and Problems List, the Burden of Kidney Disease, and the Effects of Kidney Disease. The SF-12 scores were aggregated into two component summaries: the physical component summary (PCS) and the mental component summary (MCS). Scores were calculated according to the KDQOL 1.3 Manual for Use and Scoring (Hays et al., 1997). They ranged from 0 to 100, with a higher score indicating a better HRQOL. The Chinese version of the KDQOL-36TM has demonstrated acceptable levels of internal consistency (with a Cronbach’s alpha ranging from 0.69 to 0.78) and test–retest reliability (ICC ranging from 0.70 to 0.86). The construct validity of the Chinese version of the KDQOL-36TM was supported by the convergent validity and known-group validity (Tao et al., 2014). 3.8. Sample size estimation The size of the sample was estimated from the results of the normal gait speed reported by Painter et al. (2000) in a controlled study examining the effects of an exercise program for hemodialysis patients. Based on repeated measures analysis of variance (ANOVA), the total sample size needed to adequately detect between-group differences was determined to be 96, 48 for each group. The design achieved 80% power with a 5% significance level, assuming that the correlation of the repeated measures was 0.8. According to a previous study, a dropout rate of 17% was observed for patients on home exercise (Konstantinidou et al., 2002). With a dropout rate of 17%, a total of 112 subjects were required for the current study. 3.9. Statistical analysis Data analysis was carried out using the Statistical Package for Social Sciences (version 20.0). Descriptive statistics were used to display demographic and clinical information. Repeated measures analysis of variance (ANOVA) was employed to determine the effects of the program on continuous outcome variables with normal distribution. The Friedman test and the Mann–Whitney U test were used for data that were not normally distributed. Bonferroni corrections were used for pairwise comparisons to adjust type I errors. An intention-to-treat analysis was applied to avoid potential biases due to non-random patient drop-outs. Multiple imputation was adopted to handle missing data. All statistical tests were two-tailed, and P < 0.05 was considered statistically significant. Effect
size was estimated by calculating partial eta squared h2p for group comparisons, and Cohen’s d for comparisons of changes in mean over time. For interpretation, the small, moderate, and large effect sizes were defined as h2p < 0:01, 0.01–0.06, and >0.14, respectively; and Cohen’s d < 0.2, 0.2–0.5, and >0.8, respectively (Cohen, 1988). 4. Results Four hundred and sixty-six hemodialysis patients were assessed for eligibility, and 277 of them were excluded. A total of 113 patients were recruited and randomly allocated – 57 to the study group and 56 to the control group. Five patients in the control group and one from the study group discontinued the intervention. Fig. 3 displays the CONSORT flowchart (Moher et al., 2012). 4.1. Baseline demographics and clinical characteristics Table 1 shows that the mean age of the participants was 54.8, ranging from 27 to 74 years old. There were more males (52.2%) than females. The majority of the participants were married (82.3%) and not working (92%). Only 7.1% of the participants had received a primary education or below. Primary education refers to Grade 1 to Grade 6 or elementary school in Western countries. Chronic glomerular nephritis (25.7%) was the major cause of their renal failure. The average duration for dialysis was 84.1 months, with a range of 5–334 months. Subjects with no reported co-morbidities constituted 26.3% of the sample. 4.2. Effects of the nurse-led case management of home exercise 4.2.1. Primary outcomes With regard to the normal gait speed, as shown in Table 2, the repeated measures ANOVA indicated a significant between-group effect, with the study group experiencing greater improvements than the control group [F(1,111) = 4.42, p = 0.038, h2p ¼ 0:038]. With regard to the within-group effects, a significant improvement in the normal gait speed across the three time points was observed only in the study group [F(2,112) = 9.53, p < 0.001, h2p ¼ 0:145], with a significant mean increase (p = 0.001, Cohen’s d = 0.45) of 12.02 (3.03) centimeters per second (cm/s) from baseline to week 12. The interaction effect between groups and time points was also significant, indicating that the increase for the groups was different at the three time points [F(1.88,208.09) = 3.30, p = 0.042, partial eta squared = 0.029]. For the fast gait speed, there was a marginally significant between-group effect (F(1,111) = 3.93, p = 0.05, partial eta squared = 0.034), with the study group demonstrating greater improvement in the repeated measures ANOVA analysis. A significant interaction effect between the two groups and three time points was observed [F(1.81,201.26) = 4.21, p = 0.019, h2p ¼ 0:037]. A significant within-group difference was only noted in the study group [F(1.66,92.95) = 8.08, p = 0.001, h2p ¼ 0:126], with a significant mean improvement (p = 0.005, Cohen’s d = 0.29) of 11.08 (3.32) cm/s, from baseline to week 12.
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Enrollment
Assessed for eligibility (n = 466) Excluded (n = 353) Not meeting inclusion criteria (n = 277) Refused to participate (n = 76)
Allocated to intervention (n = 56)
Received allocated intervention (n = 57)
Received allocated intervention (n = 56)
Did not receive allocated intervention (n = 0)
Did not receive allocated intervention (n = 0)
Lost to follow up (n =0)
Lost to follow up (n = 1) (Reason: transfer to another hospital)
Follow up
Allocated to intervention (n = 57)
Discontinued intervention (n =1) (Reason: catheter infection)
Analysis
Allocation
Randomized (n = 113)
Analyzed (n = 57)
Analyzed (n = 56)
Excluded from analysis (n = 0)
Excluded from analysis (n = 0)
Discontinued intervention (n = 4) (Reasons: 1 ankle injury, 1fever, 2 withdraw: not interested)
Fig. 3. Flowchart of the participants throughout the trial.
4.3. Secondary outcomes 4.3.1. 10-STS performance For the 10-STS performance, the repeated measures ANOVA revealed that the between-group differences approached significance [F(1,111) = 3.92, p = 0.050], with the increases in the study group being greater than those in the control group. A significant interaction effect [F(1.65,182.66) = 6.11, p = 0.005] was also observed, suggesting that the trends of increase for the two groups were different over time. Significant within-group increases across the three time points were noted for both the study [F(2,112) = 101.99, p < 0.001] and control groups [F(1.47,80.76) = 21.22, p < 0.001]. The time taken by the
patients in the study group to complete the 10-STS test decreased from 19.78 (6.57) to 14.03 (4.97) seconds, from baseline to week 12, p < 0.001. The mean actual improvement was 5.75 (3.88) s. A similar trend was noted in the control group with the mean actual improvement of 4.93 (+13.88) s. However, the study group patients took less time than the control group patients to complete the 10-STS after finishing the program (F(1,111) = 8.72, p = 0.004). For details, please refer to Table 3. 4.3.2. HRQOL For HRQOL, the result of the Friedman tests showed that significant within-group effects in the study group were
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Table 1 Baseline demographic and clinical characteristics. Characteristics Age (years; M, SD) Gender (male) Marital status Married Single Divorced/widowed Education level Primary or below Secondary Tertiary or above Employment Full time Part time Retired Homemaker Others Insurance Government insurance Self-pay Financial status More than sufficient Barely sufficient Insufficient Extremely insufficient Primary cause for renal failure Chronic glomerular nephritis Hypertension Diabetes Gout Unknown Others Comorbidity No other diseases Hypertension Cardiac disease Diabetes Respiratory disease Others Hemodialysis duration (months; M, SD) Hemoglobin (g/L; M, SD)
Study (n = 57)
Control (n = 56)
Total (n = 113)
53.02 (11.62) 29 (50.9%)
56.68 (9.67) 30 (53.6%)
54.83 (10.81) 59 (52.2%)
42 (73.7%) 7 (12.3%) 8 (14%)
51 (91.1%) 0 (0.0%) 5 (8.9%)
93 (82.3%) 7 (6.2%) 13 (11.5%)
4 (7.0%) 43 (75.4%) 10 (17.5%)
4 (7.2%) 39 (69.6%) 13 (23.2%)
8 (7.1%) 82 (72.5%) 23 (20.4%)
4 1 36 6 10
2 2 45 2 5
6 3 81 8 15
(7.0%) (1.8%) (63.2%) (10.5%) (17.5%)
(3.6%) (3.6%) (80.4%) (3.6%) (8.9%)
(5.3%) (2.7%) (71.7%) (7.1%) (13.3%)
47 (82.5%) 10 (17.5%)
52 (91.0%) 5 (9.0%)
98 (86.7%) 15 (13.3%)
9 27 12 9
(15.8%) (47.4%) (21.1%) (15.8%)
8 37 9 2
(14.3%) (66.1%) (16.1%) (3.6%)
17 64 21 11
(15.0%) (56.6%) (18.6%) (9.7%)
13 (22.8%) 10 (17.5%) 7(12.3%) 9 (15.8%) 13 (22.8%) 5(8.8%)
16 16 9 5 6 4
(28.6%) (28.6%) (16.1%) (8.9%) (10.7%) (7.2%)
29 26 16 14 19 9
(25.7%) (23.0%) (14.2%) (12.4%) (16.8%) (8.0%)
16 (23.5%) 30 (44.1%) 15 (22.1%) 5 (7.4%) 0 (0%) 2 (2.9%) 83.46 (61.37) 105.18 (12.00)
19 (29.2%) 26 (40.0%) 11 (16.9%) 3 (4.6%) 1 (1.5%) 5 (7.7%) 84.70 (70.55) 106.94 (13.53)
35 (26.3%) 56 (42.1%) 26 (19.5%) 8 (6.0%) 1 (0.7%) 7 (5.3%) 84.07 (65.78) 106.05 (12.74)
Note: some participants suffered more than one disease, causing the number of the comorbidities greater than the number of patients for each trial group. M = mean; SD = standard deviation.
demonstrated for all kidney disease-specific domains. The scores on Symptom and Problem List increased over time, with x2 (2, n = 57) = 7.92, p = 0.019. A post hoc analysis indicated a significant improvement in the Symptom and Problem List from week 6 to week 12, with z = 2.53, p = 0.011. With regard to the Burden of Kidney Disease subscale, a statistically significant within-group effect for the study group across the three time points was found, with x2 (2, n = 57) = 9.31, p = 0.01. The patients’ perception of the Burden of Kidney Disease decreased from baseline to week 12, with z = 2.51, p = 0.012. With regard to the Effects of Kidney Disease subscale, a significant withingroup effect was likewise only observed in the study group, with x2 (2, n = 57) = 11.08, p = 0.004. No significant between-group differences were noted for any of the kidney disease-specific subscales at either time point in the Mann–Whitney U tests. With regard to scores on the PCS and MCS subscales, neither a between-group nor a within-group effect was found. For details, please refer to Table 3.
5. Discussion The results of the study indicated that the 12-week program on nurse case management of home exercise is effective at improving the physical function of patients and further improving their overall quality of life. 5.1. Effectiveness of the program on physical function The significant improvements in gait speed and 10-STS performance support the claim that the 12-week nurse case management program on home exercise is effective at enhancing physical function. For the study group, a mean increase of 12.01 cm/s (equivalent to 0.12 m/s) on the normal gait speed from baseline to week 12 was found. Previous studies suggested that a change of 0.1 m/s on the normal gait speed constitutes substantial meaningful change (Chui et al., 2012); indicating that the improvements on gait speed in the current study were both statistically and clinically significant.
X. Tao et al. / International Journal of Nursing Studies 52 (2015) 1029–1041
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Table 2 Comparisons of physical performance tests by groups over three time points. Physical performance tests
Baseline n
Mean (SD)
At 6 weeks
At 12 weeks
Between Groups
Within groups
Interaction effect
Mean (SD)
Mean (SD)
F (p-value)
F (p-value) [A,B,C]
F (p-value)
Normal gait speed (cm/s)
4.422 (*0.038)
Study
57
120.88 (25.46)
128.44 (24.00)
132.90 (27.89)
Control
56
116.65 (27.53)
119.19 (23.44)
119.38 (23.18)
F (p-value) Fast gait speed (cm/s)
4.302 (*0.040)
0.719 (0.398)
57
167.57 (37.92)
174.54 (35.54)
178.65 (37.66)
Control
56
159.71 (40.40)
161.36 (37.96)
159.73 (35.85)
Control
9.528 (*
