506230
2013
CRE28510.1177/0269215513506230Clinical RehabilitationPorserud et al.
CLINICAL REHABILITATION
Article
The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial
Clinical Rehabilitation 2014, Vol. 28(5) 451–459 © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215513506230 cre.sagepub.com
Andrea Porserud1,2, Amir Sherif3 and Anna Tollbäck2 Abstract Objective: Assessment of feasibility and effects of an exercise training programme in patients following cystectomy due to urinary bladder cancer. Design: Single-blind, pilot, randomized controlled trial. Setting: University hospital, Sweden. Subjects: Eighteen patients (64–78 years), of 89 suitable, cystectomized due to urinary bladder cancer, were randomized after hospital discharge to intervention or control. Interventions: The 12-week exercise programme included group exercise training twice a week and daily walks. The control group received only standardized information at discharge. Main outcome measures: Trial eligibility and compliance to inclusion were registered. Assessments of functional capacity, balance, lower body strength and health-related quality of life (HRQoL) with SF-36. Results: Out of 122 patients 89 were eligible, but 64 did not want to participate/were not invited. Twentyfive patients were included, but 7 dropped out before randomization. Eighteen patients were randomized to intervention or control. Thirteen patients completed the training period. The intervention group increased walking distance more than the control group, 109 m (75–177) compared to 62 m (36–119) (P = 0.013), and role physical domain in SF-36 more than the control group (P = 0.031). Ten patients were evaluated one year postoperatively. The intervention group had continued increasing walking distance, 20 m (19–36), whereas the control group had shortened the distance −15.5 m (−43 to −5) (P = 0.010). Conclusions: A 12-week group exercise training programme was not feasible for most cystectomy patients. However, functional capacity and the role-physical domain in HRQoL increased in the short and long term for patients in the intervention group compared with controls. Keywords Urinary bladder cancer, radical cystectomy, exercise
1Department
of Physiotherapy, Karolinska University Hospital, Stockholm, Sweden 2Karolinska Institute, Department of Neurobiology, Care Science and Society (NVS), Division of Physiotherapy, Huddinge, Sweden 3Department of Surgical and Perioperative, Sciences, Urology and Andrology, Umeå University, Umeå, Sweden
Corresponding author: Andrea Porserud, Department of Physiotherapy, Karolinska University Hospital, A6:U1, 171 76 Stockholm, Sweden. Email: [email protected]
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
452
Clinical Rehabilitation 28(5)
Introduction
Methods
High physical function is one of the health-related quality of life factors that predict longer survival in patients with urothelial urinary bladder cancer.1 The survival of patients diagnosed with cancer is constantly increasing.2 However, invasive urinary bladder cancer is an aggressive form with a fiveyear survival rate reported in 66–68% of male and 58–66% of female patients after a radical cystectomy with urinary diversion.3 For classification of tumour stage, the 2002 TNM classification is widely accepted.4 Patients diagnosed with muscle invasive urothelial urinary bladder cancer without known dissemination and acceptable renal function are preferably treated with neoadjuvant chemotherapy followed by radical cystectomy.5 Major surgery such as cystectomy is associated with the risk of a very poor general condition and suboptimal nutritional status. Furthermore, a substantial number of these patients already have a very poor performance status prior to surgery due to old age, chemotherapy or the cancer itself. Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30), Kulaksizoglu et al. found that after radical cystectomy, patients with a mean age of 55 (SD 8) years took 12 months to adapt to their new health status.6,7 The EORTC QLQ-C30 functional score decreased significantly three months postoperatively. It is well known that physical activity positively affects health, survival and quality of life in healthy people.8 It has recently been demonstrated that physical activity improves physical function, as well as different physiological and psychological aspects in patients with cancer, both during and after treatment.9–11 Despite an increasing number of studies that report the positive effects of physical exercise in patients with cancer, such patients are not routinely advised to engage in physical activity. 12,13 The effects of physical exercise in patients who have undergone radical cystectomy due to urinary bladder cancer have not been evaluated. Therefore, the aim of this study was to assess the feasibility and effects of an early exercise training programme.
Between May 2008 and May 2010, patients who underwent radical cystectomy with ileal conduit due to urinary bladder cancer at the Karolinska University Hospital, Solna, Stockholm, were invited to enter a randomized controlled trial.14 Inclusion criteria were men and women aged 60–80 years who could understand Swedish, lived in the Stockholm County Council area and were mobile with or without a walking aid. Patients with a recurring malignancy or scheduled for robot-assisted laparoscopic surgery were excluded. During their preoperative check-up approximately 10 days before surgery, the patients received oral and written information about the study and were invited to take part. During their hospital stay, all patients received individually tailored physiotherapy aimed at early mobilization and the prevention of postoperative complications. At discharge, all patients were given standardized oral and written information about the need for daily walks and to avoid lifting heavy objects. Baseline data were collected within a week after discharge from the hospital or postoperative care clinic. Thereafter, the patients were consecutively and randomly allocated to the intervention or control group in blocks of 10, where the patients drew a lot from an envelope containing 10 pieces of paper, five of which were marked “control” and five “training”. When the first envelope was empty a new envelope with 10 lots was prepared. Blocked randomization was used to ensure uniform distribution between the two groups at the beginning of the study. It was not possible to blind patients to the group to which they were allocated. However, they were instructed not to reveal their group to the person who performed the assessments. The intervention group took part in a group exercise training programme at the hospital for 45 minutes twice a week over a 12-week period. The training programme started within a week after the baseline assessment and its main aim was to increase physical function. It was led by the physiotherapist responsible for the study and consisted of strength and endurance training for the lower extremities such as walking and strengthening exercises,
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
453
Porserud et al. balance training, mobility training and stretching exercises. Music was used as inspiration. The participants were also instructed to take walks at a selfselected pace, three to five days a week for at least 15 minutes and to document them in an exercise diary. Adherence to the group exercise training programme was registered by the physiotherapist responsible. The daily walks were reported by the patients in an exercise training diary. Patients who were allocated to the control group did not receive any guidance about training from the physiotherapist connected to the study, but they were offered the same exercise as the intervention group on completion of the data collection. A physiotherapist who was not involved in the training procedure and blinded to group allocation performed all assessments in the course of the first week after discharge, the 14th week after the baseline assessment and one year after surgery. The six-minute walk test was used to evaluate patients’ functional capacity, with a walking aid if necessary.15 The test was carried out twice with a 45-minute break in between. The patients received no encouragement during the test and the one in which the longest distance was covered was used for analysis. To evaluate balance, patients walked two laps in a figure of eight drawn on the floor, with a walking aid if necessary.16 Lower body strength was assessed by means of the 30-second chair stand test.17 The SF-36 was employed to evaluate health-related quality of life.18 The patients were weighed on a regular basis in order to check that they did not continue to lose weight. A total of 23 patients was required in each group for statistical power of 80% and statistical significance of P < 0.05, as well as a 100-m increase in the distance walked in the intervention group and 75 m in the control group, with a standard deviation of 30 m. The original intention was to include a total of 50 patients in order to minimize the problem caused by drop-out. Due to the data level and the nonnormally distributed continuous data, the Wilcoxon signed rank test and the Mann–Whitney U-test were used for assessment of intragroup and intergroup differences, respectively.
The Regional Ethical Review Board at the Karolinska Institute approved the study, no. 2007/ 1401-31/3.
Results Figure 1 illustrates the progression of the study. The 25 patients who were recruited signed a written consent form the day before surgery, but seven dropped out before the baseline assessment (Figure 1). Thus 18 patients, 4 women and 14 men with a mean age of 66.7 years (range 64–68) and 73.7 years (65– 78), respectively, with T1G3 + CIS N0 M0 – T4bG3 N0–N1 M0 urothelial urinary bladder cancer took part in the study. The results are presented as a median (range). The length of the patients’ hospital stay was 13.5 days (10–25). In addition, four of the last patients to be recruited received extra postoperative care at another clinic for 5.5 days (3–8) and two were readmitted to hospital for 9 and 26 days respectively. At baseline, 25.5 days (19–139) after surgery, there were no significant differences between the groups in terms of the patients’ age, BMI before surgery, length of hospital stay or days from discharge to baseline. Nor were any significant differences found between them in the six-minute walk test, figure of eight, 30-second chair stand test or the SF-36 (Table 1). The patients attended 76% (67–95) of the group exercise training sessions. According to their exercise diaries, they had taken daily walks on 87% (56–100) of the days during the 12-week period, averaging 3.5 hours (2–11.5) per week (Table 2). After the training period, both the intervention and the control group members had increased the distance walked (P = 0.043 and P = 0.012, respectively) (Table 3), but the increase was higher among the intervention group members (P = 0.013) (Table 4). In the SF-36 role physical domain, the intervention group improved more than the control group (P = 0.031) (Table 4). One year after surgery, the patients in the intervention group had increased the distance walked more than the control group (P = 0.010) (Table 4). The members in the intervention group had increased the distance walked one year after surgery (P = 0.018), whereas the members in
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
454
Clinical Rehabilitation 28(5)
Assessed for eligibility (n=122)
Excluded (n=33) -Age (n=27) -Language (n=2) -Laparoscopic surgery (n=4) Did not want to par cipate/not invited (n=64)
Assigned to study (n=25)
Re-admi ed to hospital before randomiza on (n=2)
Extra postopera ve care a er discharge (n=4)
Home a er discharge (n=21)
Drop-out (n=7) -Too poor general condi on according to pa ent (n=5) -Did not need assistance with exercise, according to pa ent (n=1) -Received an orthotopic bladder subs tu on (n=1) Randomiza on, by lot in blocks (n=18)
Interven on group (n=9) Drop-out (n=4) -Deceased (n=3) -Did not need assistance with exercise: (n=1)
Within the first week a er discharge
Control group (n=9)
Drop-out (n=1) -Deceased
Interven on group (n=5)
Drop-out (n=1) -Unknown reason Interven on group (n=4)
Within the 14th week a er discharge
Control group (n=8)
One year a er surgery
Drop out (n=2) -Deceased (n=1) -Too poor general condi on (n=1) Control group (n=6)
Figure 1. CONSORT flowchart illustrating all identified patients (n = 122).
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
455
Porserud et al. Table 1. Baseline data. Intervention n = 9
Median (range)
Age BMI before surgery Days at hospital Days from discharge to baseline Physical assessments 6MWT (m) Figure of eight (s) Steps outside (n) 30-s chair stand test (n) SF-36 Physical functioning Role physical Bodily pain General health Vitality Social functioning Role emotional Mental health Physical health score Mental health score
Control n = 9 Mean (SD)
Median (range)
P-value Mean (SD)
74 (64–78) 22 (19–29) 13 (10–21) 9 (4–37)
72 (5) 23 (3) 14 (3) 13 (11)
73 (65–76) 24 (20–29) 14 (11–25) 14 (4–126)
72 (4) 25 (3) 15 (4) 28 (39)
0.657 0.233 0.168 0.376
431 (359–598) 27 (21–98) 2 (0–14) 11 (8–14)
438 (73) 34 (24) 4 (5) 11 (2)
483 (217–558) 33 (19–55) 2 (0–17) 10 (7–12)
460 (99) 33 (10) 4 (6) 10 (2)
0.145 0.309 0.891 0.465
55 (35–85) 0 (0–50) 62 (22–84) 62 (30–100) 40 (25–95) 63 (25–100) 0 (0–100) 76 (56–100) 37 (26–42) 38 (32–66)
61 (15) 8 (18) 59 (24) 62 (21) 48 (25) 63 (23) 41 (49) 80 (16) 35 (5) 44 (13)
50 (20–90) 0 (0–25) 52 (31–100) 65 (20–82) 45 (10–65) 63 (25–100) 0 (0–100) 60 (28–88) 37 (19–49) 35 (17–60)
56 (19) 3 (8) 62 (31) 59 (19) 40 (21) 58 (29) 30 (42) 60 (20) 36 (9) 37 (13)
0.394 0.496 0.894 0.859 0.722 0.653 0.768 0.063 0.825 0.310
BMI, body mass index; 6MWT, six-minute walk test.
Table 2. Individual exercise during 12 weeks. Patient
Sessions of group exercise (n)
Individual walks (h/week)
3 7 8 13 18 25
15 16 18 20 12 16
3.0 11.5 4.5 4.0 2.4 2.0
the control group had decreased the distance walked one year after surgery (P = 0.002) (Table 3). No other differences were observed within or between the groups (Table 4).
Discussion This study demonstrated that a 12-week group exercise training programme for seriously ill patients who had recently undergone open radical cystectomy due to urinary bladder cancer increased
physical function and positively affected the role physical domain of health-related quality of life in those patients who completed the programme. However, the programme was not feasible for the majority of the patients. There were many dropouts before randomization, and during the training period and follow-up period. Also, the recruitment procedure was not satisfactory. The major limitation in this study is the lack of feasibility. The three parts that contribute to that we cannot demonstrate feasibility are the unknown
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
456
Clinical Rehabilitation 28(5)
Table 3. Group results from the 6MWT after the training period and one year after surgery. T1
T2
T3
Median (range) Mean (SD) Median (range)
Completed test at T1,T2 and T3 Intervention (n = 4) 435 (359–455) Control (n = 6) 495 (432–558) Completed test at T1 and T2 Intervention (n = 5) 438 (359–598) Control (n = 8) 495 (217–558)
421 (43) 494 (42)
Mean (SD) Median (range)
526 (478–608) 535 (55) 558 (519–606) 560 (29)
P-value Mean (SD)
554 (498–627) 558 (53) 537 (488–600) 537 (36)
456 (87) 539 (478–707) 569 (91) 463 (106) 556 (282–606) 525 (101)
0.018 0.002 0.043 0.012
T1, Baseline assessments; T2, assessments after the training period within 14 weeks after baseline; T3, assessments one year after surgery. 6MWT, six-minute walk test.
number of patients who were not interested to enter the study, the unknown number of patients who were not invited to participate, and the large number of drop-outs. Unfortunately there was no registration of when patients were asked to participate but declined, it is therefore not possible to know how many they were, nor why they had no interest in participating. Furthermore, not all patients assessed for eligibility were invited to enter the study. Due to misunderstandings and shortcomings in information routines concerning new patients in the department we cannot know how many would have agreed to participate in the study. Another obstacle in the present study, as is the case with most studies of patients with a high mortality rate, was the large number of drop-outs. Five of the seven patients that left the study before randomization declared that they were too physically and mentally exhausted after discharge to travel back to the hospital for baseline assessments and randomization. During the training period, three patients in the intervention group and one patient in the control group dropped out due to advanced cancer, and deceased later on. One of the patients who left the intervention group attended the 12 weeks of training but died before the assessments after the training period. One patient died during the longterm follow-up, also due to advanced cancer. Despite major surgery, approximately 50% of the patients died within five years after a radical cystectomy. However, there were no systematic biases due
to drop-outs. Because of the difficulties recruiting patients during the two-year study period and the many drop-outs, we decided to evaluate the results in this pilot study based on the existing number of patients. The small sample size could therefore cause Type II errors. According to Jones et al., surgery is the most common form of cancer therapy for solid tumours.19 Nevertheless, to our knowledge the effects of physical exercise after abdominal surgery have only been evaluated in one study (randomized controlled trial),20 where the highly intensive postoperative mobilization of all 119 participants could be one reason why no differences in physical function between the groups were observed. Such intensive mobilization would not have been appropriate for the seriously ill patients in this study. In the present study, both groups walked a longer distance after the 12 weeks, but the intervention group had improved more than the control group. This indicates that the patients who took part in the exercise programme benefitted from physical exercise shortly after discharge from hospital. However, even more interesting is the fact that one year after surgery, the patients in the intervention group had continued to improve the distance walked, whereas the patients in the control group had reduced it. According to the American Thoracic Society, no reliable reference values for the six-minute walk test have been reported.15 However, the clinical relevance of the increased physical function in the
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
457
Porserud et al. Table 4. Results after the training period and one year after surgery. Difference n Physical assessments 6MWT (m) T2–T1 T3–T2 Figure of T2–T1 eight (s) T3–T2 Steps T2–T1 outside (n) T3–T2 30-s chair T2–T1 stand test T3–T2 (n) SF-36 Physical T2–T1 functioning T3–T2 Role physical T2–T1 T3–T2 Bodily pain T2–T1 T3–T2 General T2–T1 health T3–T2 Vitality T2–T1 T3–T2 Social T2–T1 functioning T3–T2 Role T2–T1 emotional T3–T2 Mental T2−T1 health T3–T2 T2–T1 Physical health score T3–T2 Mental T2–T1 health score T3–T2
Intervention Median (range)
Control Mean (SD)
P-value
n
Median (range)
8 6 8 6 8 6 7 6
61.5 (36.0–119.0) 62.8 (26.3) −15.5 (−43.0–−4.5) −19.2 (15.3) −5 (−8.0–0.0) −4.6 (2.8) 3.8 (−4.0–6.0) 2.6 (3.6) 0.0 (−6.0–25.0) 3.1 (9.3) −0.5 (−5.0–3.0) −0.7 (2.7) 3.0 (0.0–4.0) 2.6 (1.6) 0.0 (−2.0–1.0) −0.3 (1.0)
5 4 5 4 5 4 5 4
109.0 (75.0–177.0) 112.9 (40.1) 20.0 (19.0–36.0) 23.8 (8.2) −2.0 (−75.0–0.0) −17.0 (32.5) 3.4 (0.2–22.0) 7.2 (10.0) −2.0 (−7.0–0.0) −2.0 (2.9) −1.5 (−4.0–5.0) −0.5 (4.0) 4.0 (0.0–6.0) 3.2 (2.3) 4.0 (−1.0–6.0) 3.3 (3.4)
5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4
25.0 (20.0–40.0) 28.0 (7.6) 8 5.0 (0.0–5.0) 3.8 (2.5) 6 100.0 (50.0–100.0) 90.0 (22.4) 8 −12.5 (−25.0–0.0) −12.5 (14.4) 6 22.0 (−10.0–43.0) 15.4 (22.0) 8 18.0 (16.0–59.0) 27.7 (20.9) 6 10.0 (−10.0–32.0) 11.8 (17.7) 8 −5.0 (−15.0–10.0) −3.7 (11.1) 6 25.0 (5.0–35.0) 25.0 (12.2) 8 2.5 (−5.0–10.0) 2.5 (6.5) 6 37.5 (0.0–37.5) 27.5 (16.3) 8 0.0 (0.0–25.0) 6.3 (12.5) 6 33.3 (0.0–100.0) 33.3 (40.8) 8 0.0 (0.0–33.3) 8.3 (16.7) 6 4.0 (0.0−24.0) 7.2 (10.0) 8 4.0 (0.0–8.0) 4.0 (4.6) 6 17.7 (11.0–22.8) 16.4 (5.0) 8 0.7 (−4.2–8.2) 1.4 (5.5) 6 5.4 (−6.7–20.9) 5.6 (10.0) 8 1.1 (−2.8–10.1) 2.4 (5.6) 6
22.5 (15.0–65.0) 5.0 (−25.0–15.0) 37.5 (0.0–100.0) 12.5 (−75.0–50.0) 2.0 (−30.0–69.0) 0.0 (−48.0–69.0) 6.0 (−31.3–27.0) −2.5 (−34.5–10.0) 20.0 (−18.3–45.0) −3.3 (−25.0–25.0) 6.3 (−37.5–37.5) 6.3 (−25.0–50.0) 0.0 (−100.0–100.0) 0.0 (−66.7−33.3) 12.0 (−20.0–44.0) 6.0 (−12.0–8.0) 10.4 (0.7–20.3) 2.9 (−19.7–9.6) 7.3 (−33.1–14.6) 1.4 (−11.1–9.9)
Mean (SD)
28.1 (17.3) 0.0 (15.2) 40.6 (44.2) 4.2 (43.1) 12.5 (34.0) 2.8 (39.2) 3.8 (20.1) −9.1 (17) 19.0 (21.4) −2.8 (17.7) 7.8 (25.8) 4.2 (28.1) 8.3 (55.6) 0.0 (36.5) 12.5 (22.4) 1.3 (9.0) 10.7 (6.3) −0.4 (10.8) 2.1 (16.0) 0.4 (8.1)
0.013 0.010 0.605 0.831 0.098 0.915 0.554 0.103 0.504 0.914 0.031 0.184 1.000 0.130 0.508 0.745 0.766 0.454 0.150 0.912 0.389 0.903 0.339 0.819 0.079 1.000 1.000 0.670
T1, Baseline assessments; T2, assessments after the training period within 14 weeks after baseline; T3, assessments one year after surgery. 6MWT, six-minute walk test.
intervention group is reflected in the improved SF-36 role physical domain. Patients who undergo major surgery are not expected to have a high health-related quality of life, but when comparing the patients in the present study to the general Swedish population aged 65
years and older, there are some interesting differences in the SF-36 scores.21 At baseline, the participants’ scores were lower than the 25th percentile of the matched population in five out of the eight SF-36 domains. The very low scores underline the importance of rehabilitation after a radical
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
458
Clinical Rehabilitation 28(5)
cystectomy. This conclusion is probably confirmed in a study from 2007 in which Karvinen et al. reported that out of 525 urinary bladder cancer survivors, of whom 20% had undergone a cystectomy, only 22% adhered to public health exercise guidelines.22 Furthermore, 16% exercised occasionally but insufficiently and 62% were completely sedentary. They concluded that although only a few of the patients adhered to the guidelines, exercise was positively associated with quality of life in urinary bladder cancer survivors. This first pilot study on the feasibility and effects of an early exercise training programme after an open radical cystectomy due to urinary bladder cancer gives rise to new research questions. Due to poor health status at discharge from hospital, all patients were not expected to be able to participate in an early exercise training programme, but the majority of the patients.. Unfortunately, due to shortcomings in routines for inviting patients to the study, we cannot show that the training programme was feasible for the patients. However, what is important is that those who took part benefitted from the programme in the short and long term. In order to achieve the best possible outcome, such patients should be offered training at a location close to their home as soon as their health allows it. It seems important to explore what kinds of exercise and intensity level benefit these patients the most, as well as where the exercise programme should be located. In view of the results of the study, at our hospital we now aim to improve the health-related quality of life of patients who have undergone a cystectomy due to urinary bladder cancer by providing individual guidance about physical exercise. Clinical messages •• A 12-week exercise training programme following radical cystectomy was not feasible in a majority of patients. •• For patients completing the exercise training programme in the intervention group, functional capacity and role physical domain of health-related quality of life increased in short and long term compared to controls.
Acknowledgements The authors wish to thank Ulrika Holdar for performing all the assessments with endless patience and enthusiasm and Lisbet Broman for her valuable assistance with the statistical analyses.
Conflict of interest The author declares that there is no conflict of interest.
Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
References 1. Roychowdhury DF, Hayden A and Liepa AM. Healthrelated quality-of-life parameters as independent prognostic factors in advanced or metastatic bladder cancer. J Clin Oncol 2003; 21: 673–678. 2. Stull VB, Snyder DC and Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr 2007; 137(suppl): 243S–248S. 3. Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: longterm results in 1,054 patients. J Clin Oncol 2001; 19: 666–675. 4. Oosterlinck W, Lobel B, Jakse G, Malmstrom PU, Stockle M and Sternberg C. Guidelines on bladder cancer. Eur Urol 2002; 41: 105–112. 5. Stenzl A, Cowan NC, De Santis M, et al. Treatment of muscle-invasive and metastatic bladder cancer: update of the EAU guidelines. Eur Urol 2011; 59: 1009–1018. 6. Kulaksizoglu H, Toktas G, Kulaksizoglu IB, Aglamis E and Unluer E. When should quality of life be measured after radical cystectomy? Eur Urol 2002; 42: 350–355. 7. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–376. 8. Warburton DE, Nicol CW and Bredin SS. Health benefits of physical activity: the evidence. Cmaj 2006; 174: 801–809. 9. Galvao DA and Newton RU. Review of exercise intervention studies in cancer patients. J Clin Oncol 2005; 23: 899–909. 10. Ingram C and Visovsky C. Exercise intervention to modify physiologic risk factors in cancer survivors. Semin Oncol Nurs 2007; 23: 275–284. 11. Knols R, Aaronson NK, Uebelhart D, Fransen J and Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
459
Porserud et al. of randomized and controlled clinical trials. J Clin Oncol 2005; 23: 3830–3842. 12. Jones LW and Courneya KS. Exercise discussions during cancer treatment consultations. Cancer Pract 2002; 10: 66–74. 13. Stevinson C and Fox KR. Role of exercise for cancer rehabilitation in UK hospitals: a survey of oncology nurses. Eur J Cancer Care (Engl) 2005; 14: 63–69. 14. Bricker EM. Bladder substitution after pelvic evisceration. Surg Clin North Am 1950; 30: 1511–1521. 15. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166: 111–117. 16. Frändin K, Sonn U, Svantesson U, et al. Functional balance tests in 76-year-olds in relation to performance, activities of daily living and platform tests. Scand J Rehabil Med 1995; 27: 231–241. 17. Jones CJ, Rikli RE and Beam WC. A 30-s chair-stand test as a measure of lower body strength in communityresiding older adults. Res Q Exerc Sport 1999; 70: 113–119.
18. Sullivan M, Karlsson J and Ware JE, Jr. The Swedish SF-36 Health Survey – I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med 1995; 41: 1349–1358. 19. Jones LW, Peppercom J, Scott JM and Battaglini C. Exercise therapy in the management of solid tumors. Curr Treat Options Oncol 2010; 11: 45–58. 20. Houborg KB, Jensen MB, Rasmussen P, Gandrup P, Schroll M and Laurberg S. Postoperative physical training following colorectal surgery: a randomised, placebo-controlled study. Scand J Surg 2006; 95: 17–22. 21. Sullivan M, Karlsson J and Taft C. SF-36 Hälsoenkät: Swedish manual and interpretation guide, second edition. Gothenburg: Sahlgrenska University Hospital, 2002. 22. Karvinen KH, Courneya KS, North S and Venner P. Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Cancer Epidemiol Biomarkers Prev 2007; 16: 984–990.
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
2013
CRE28510.1177/0269215513506230Clinical RehabilitationPorserud et al.
CLINICAL REHABILITATION
Article
The effects of a physical exercise programme after radical cystectomy for urinary bladder cancer. A pilot randomized controlled trial
Clinical Rehabilitation 2014, Vol. 28(5) 451–459 © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215513506230 cre.sagepub.com
Andrea Porserud1,2, Amir Sherif3 and Anna Tollbäck2 Abstract Objective: Assessment of feasibility and effects of an exercise training programme in patients following cystectomy due to urinary bladder cancer. Design: Single-blind, pilot, randomized controlled trial. Setting: University hospital, Sweden. Subjects: Eighteen patients (64–78 years), of 89 suitable, cystectomized due to urinary bladder cancer, were randomized after hospital discharge to intervention or control. Interventions: The 12-week exercise programme included group exercise training twice a week and daily walks. The control group received only standardized information at discharge. Main outcome measures: Trial eligibility and compliance to inclusion were registered. Assessments of functional capacity, balance, lower body strength and health-related quality of life (HRQoL) with SF-36. Results: Out of 122 patients 89 were eligible, but 64 did not want to participate/were not invited. Twentyfive patients were included, but 7 dropped out before randomization. Eighteen patients were randomized to intervention or control. Thirteen patients completed the training period. The intervention group increased walking distance more than the control group, 109 m (75–177) compared to 62 m (36–119) (P = 0.013), and role physical domain in SF-36 more than the control group (P = 0.031). Ten patients were evaluated one year postoperatively. The intervention group had continued increasing walking distance, 20 m (19–36), whereas the control group had shortened the distance −15.5 m (−43 to −5) (P = 0.010). Conclusions: A 12-week group exercise training programme was not feasible for most cystectomy patients. However, functional capacity and the role-physical domain in HRQoL increased in the short and long term for patients in the intervention group compared with controls. Keywords Urinary bladder cancer, radical cystectomy, exercise
1Department
of Physiotherapy, Karolinska University Hospital, Stockholm, Sweden 2Karolinska Institute, Department of Neurobiology, Care Science and Society (NVS), Division of Physiotherapy, Huddinge, Sweden 3Department of Surgical and Perioperative, Sciences, Urology and Andrology, Umeå University, Umeå, Sweden
Corresponding author: Andrea Porserud, Department of Physiotherapy, Karolinska University Hospital, A6:U1, 171 76 Stockholm, Sweden. Email: [email protected]
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
452
Clinical Rehabilitation 28(5)
Introduction
Methods
High physical function is one of the health-related quality of life factors that predict longer survival in patients with urothelial urinary bladder cancer.1 The survival of patients diagnosed with cancer is constantly increasing.2 However, invasive urinary bladder cancer is an aggressive form with a fiveyear survival rate reported in 66–68% of male and 58–66% of female patients after a radical cystectomy with urinary diversion.3 For classification of tumour stage, the 2002 TNM classification is widely accepted.4 Patients diagnosed with muscle invasive urothelial urinary bladder cancer without known dissemination and acceptable renal function are preferably treated with neoadjuvant chemotherapy followed by radical cystectomy.5 Major surgery such as cystectomy is associated with the risk of a very poor general condition and suboptimal nutritional status. Furthermore, a substantial number of these patients already have a very poor performance status prior to surgery due to old age, chemotherapy or the cancer itself. Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30), Kulaksizoglu et al. found that after radical cystectomy, patients with a mean age of 55 (SD 8) years took 12 months to adapt to their new health status.6,7 The EORTC QLQ-C30 functional score decreased significantly three months postoperatively. It is well known that physical activity positively affects health, survival and quality of life in healthy people.8 It has recently been demonstrated that physical activity improves physical function, as well as different physiological and psychological aspects in patients with cancer, both during and after treatment.9–11 Despite an increasing number of studies that report the positive effects of physical exercise in patients with cancer, such patients are not routinely advised to engage in physical activity. 12,13 The effects of physical exercise in patients who have undergone radical cystectomy due to urinary bladder cancer have not been evaluated. Therefore, the aim of this study was to assess the feasibility and effects of an early exercise training programme.
Between May 2008 and May 2010, patients who underwent radical cystectomy with ileal conduit due to urinary bladder cancer at the Karolinska University Hospital, Solna, Stockholm, were invited to enter a randomized controlled trial.14 Inclusion criteria were men and women aged 60–80 years who could understand Swedish, lived in the Stockholm County Council area and were mobile with or without a walking aid. Patients with a recurring malignancy or scheduled for robot-assisted laparoscopic surgery were excluded. During their preoperative check-up approximately 10 days before surgery, the patients received oral and written information about the study and were invited to take part. During their hospital stay, all patients received individually tailored physiotherapy aimed at early mobilization and the prevention of postoperative complications. At discharge, all patients were given standardized oral and written information about the need for daily walks and to avoid lifting heavy objects. Baseline data were collected within a week after discharge from the hospital or postoperative care clinic. Thereafter, the patients were consecutively and randomly allocated to the intervention or control group in blocks of 10, where the patients drew a lot from an envelope containing 10 pieces of paper, five of which were marked “control” and five “training”. When the first envelope was empty a new envelope with 10 lots was prepared. Blocked randomization was used to ensure uniform distribution between the two groups at the beginning of the study. It was not possible to blind patients to the group to which they were allocated. However, they were instructed not to reveal their group to the person who performed the assessments. The intervention group took part in a group exercise training programme at the hospital for 45 minutes twice a week over a 12-week period. The training programme started within a week after the baseline assessment and its main aim was to increase physical function. It was led by the physiotherapist responsible for the study and consisted of strength and endurance training for the lower extremities such as walking and strengthening exercises,
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
453
Porserud et al. balance training, mobility training and stretching exercises. Music was used as inspiration. The participants were also instructed to take walks at a selfselected pace, three to five days a week for at least 15 minutes and to document them in an exercise diary. Adherence to the group exercise training programme was registered by the physiotherapist responsible. The daily walks were reported by the patients in an exercise training diary. Patients who were allocated to the control group did not receive any guidance about training from the physiotherapist connected to the study, but they were offered the same exercise as the intervention group on completion of the data collection. A physiotherapist who was not involved in the training procedure and blinded to group allocation performed all assessments in the course of the first week after discharge, the 14th week after the baseline assessment and one year after surgery. The six-minute walk test was used to evaluate patients’ functional capacity, with a walking aid if necessary.15 The test was carried out twice with a 45-minute break in between. The patients received no encouragement during the test and the one in which the longest distance was covered was used for analysis. To evaluate balance, patients walked two laps in a figure of eight drawn on the floor, with a walking aid if necessary.16 Lower body strength was assessed by means of the 30-second chair stand test.17 The SF-36 was employed to evaluate health-related quality of life.18 The patients were weighed on a regular basis in order to check that they did not continue to lose weight. A total of 23 patients was required in each group for statistical power of 80% and statistical significance of P < 0.05, as well as a 100-m increase in the distance walked in the intervention group and 75 m in the control group, with a standard deviation of 30 m. The original intention was to include a total of 50 patients in order to minimize the problem caused by drop-out. Due to the data level and the nonnormally distributed continuous data, the Wilcoxon signed rank test and the Mann–Whitney U-test were used for assessment of intragroup and intergroup differences, respectively.
The Regional Ethical Review Board at the Karolinska Institute approved the study, no. 2007/ 1401-31/3.
Results Figure 1 illustrates the progression of the study. The 25 patients who were recruited signed a written consent form the day before surgery, but seven dropped out before the baseline assessment (Figure 1). Thus 18 patients, 4 women and 14 men with a mean age of 66.7 years (range 64–68) and 73.7 years (65– 78), respectively, with T1G3 + CIS N0 M0 – T4bG3 N0–N1 M0 urothelial urinary bladder cancer took part in the study. The results are presented as a median (range). The length of the patients’ hospital stay was 13.5 days (10–25). In addition, four of the last patients to be recruited received extra postoperative care at another clinic for 5.5 days (3–8) and two were readmitted to hospital for 9 and 26 days respectively. At baseline, 25.5 days (19–139) after surgery, there were no significant differences between the groups in terms of the patients’ age, BMI before surgery, length of hospital stay or days from discharge to baseline. Nor were any significant differences found between them in the six-minute walk test, figure of eight, 30-second chair stand test or the SF-36 (Table 1). The patients attended 76% (67–95) of the group exercise training sessions. According to their exercise diaries, they had taken daily walks on 87% (56–100) of the days during the 12-week period, averaging 3.5 hours (2–11.5) per week (Table 2). After the training period, both the intervention and the control group members had increased the distance walked (P = 0.043 and P = 0.012, respectively) (Table 3), but the increase was higher among the intervention group members (P = 0.013) (Table 4). In the SF-36 role physical domain, the intervention group improved more than the control group (P = 0.031) (Table 4). One year after surgery, the patients in the intervention group had increased the distance walked more than the control group (P = 0.010) (Table 4). The members in the intervention group had increased the distance walked one year after surgery (P = 0.018), whereas the members in
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
454
Clinical Rehabilitation 28(5)
Assessed for eligibility (n=122)
Excluded (n=33) -Age (n=27) -Language (n=2) -Laparoscopic surgery (n=4) Did not want to par cipate/not invited (n=64)
Assigned to study (n=25)
Re-admi ed to hospital before randomiza on (n=2)
Extra postopera ve care a er discharge (n=4)
Home a er discharge (n=21)
Drop-out (n=7) -Too poor general condi on according to pa ent (n=5) -Did not need assistance with exercise, according to pa ent (n=1) -Received an orthotopic bladder subs tu on (n=1) Randomiza on, by lot in blocks (n=18)
Interven on group (n=9) Drop-out (n=4) -Deceased (n=3) -Did not need assistance with exercise: (n=1)
Within the first week a er discharge
Control group (n=9)
Drop-out (n=1) -Deceased
Interven on group (n=5)
Drop-out (n=1) -Unknown reason Interven on group (n=4)
Within the 14th week a er discharge
Control group (n=8)
One year a er surgery
Drop out (n=2) -Deceased (n=1) -Too poor general condi on (n=1) Control group (n=6)
Figure 1. CONSORT flowchart illustrating all identified patients (n = 122).
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
455
Porserud et al. Table 1. Baseline data. Intervention n = 9
Median (range)
Age BMI before surgery Days at hospital Days from discharge to baseline Physical assessments 6MWT (m) Figure of eight (s) Steps outside (n) 30-s chair stand test (n) SF-36 Physical functioning Role physical Bodily pain General health Vitality Social functioning Role emotional Mental health Physical health score Mental health score
Control n = 9 Mean (SD)
Median (range)
P-value Mean (SD)
74 (64–78) 22 (19–29) 13 (10–21) 9 (4–37)
72 (5) 23 (3) 14 (3) 13 (11)
73 (65–76) 24 (20–29) 14 (11–25) 14 (4–126)
72 (4) 25 (3) 15 (4) 28 (39)
0.657 0.233 0.168 0.376
431 (359–598) 27 (21–98) 2 (0–14) 11 (8–14)
438 (73) 34 (24) 4 (5) 11 (2)
483 (217–558) 33 (19–55) 2 (0–17) 10 (7–12)
460 (99) 33 (10) 4 (6) 10 (2)
0.145 0.309 0.891 0.465
55 (35–85) 0 (0–50) 62 (22–84) 62 (30–100) 40 (25–95) 63 (25–100) 0 (0–100) 76 (56–100) 37 (26–42) 38 (32–66)
61 (15) 8 (18) 59 (24) 62 (21) 48 (25) 63 (23) 41 (49) 80 (16) 35 (5) 44 (13)
50 (20–90) 0 (0–25) 52 (31–100) 65 (20–82) 45 (10–65) 63 (25–100) 0 (0–100) 60 (28–88) 37 (19–49) 35 (17–60)
56 (19) 3 (8) 62 (31) 59 (19) 40 (21) 58 (29) 30 (42) 60 (20) 36 (9) 37 (13)
0.394 0.496 0.894 0.859 0.722 0.653 0.768 0.063 0.825 0.310
BMI, body mass index; 6MWT, six-minute walk test.
Table 2. Individual exercise during 12 weeks. Patient
Sessions of group exercise (n)
Individual walks (h/week)
3 7 8 13 18 25
15 16 18 20 12 16
3.0 11.5 4.5 4.0 2.4 2.0
the control group had decreased the distance walked one year after surgery (P = 0.002) (Table 3). No other differences were observed within or between the groups (Table 4).
Discussion This study demonstrated that a 12-week group exercise training programme for seriously ill patients who had recently undergone open radical cystectomy due to urinary bladder cancer increased
physical function and positively affected the role physical domain of health-related quality of life in those patients who completed the programme. However, the programme was not feasible for the majority of the patients. There were many dropouts before randomization, and during the training period and follow-up period. Also, the recruitment procedure was not satisfactory. The major limitation in this study is the lack of feasibility. The three parts that contribute to that we cannot demonstrate feasibility are the unknown
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
456
Clinical Rehabilitation 28(5)
Table 3. Group results from the 6MWT after the training period and one year after surgery. T1
T2
T3
Median (range) Mean (SD) Median (range)
Completed test at T1,T2 and T3 Intervention (n = 4) 435 (359–455) Control (n = 6) 495 (432–558) Completed test at T1 and T2 Intervention (n = 5) 438 (359–598) Control (n = 8) 495 (217–558)
421 (43) 494 (42)
Mean (SD) Median (range)
526 (478–608) 535 (55) 558 (519–606) 560 (29)
P-value Mean (SD)
554 (498–627) 558 (53) 537 (488–600) 537 (36)
456 (87) 539 (478–707) 569 (91) 463 (106) 556 (282–606) 525 (101)
0.018 0.002 0.043 0.012
T1, Baseline assessments; T2, assessments after the training period within 14 weeks after baseline; T3, assessments one year after surgery. 6MWT, six-minute walk test.
number of patients who were not interested to enter the study, the unknown number of patients who were not invited to participate, and the large number of drop-outs. Unfortunately there was no registration of when patients were asked to participate but declined, it is therefore not possible to know how many they were, nor why they had no interest in participating. Furthermore, not all patients assessed for eligibility were invited to enter the study. Due to misunderstandings and shortcomings in information routines concerning new patients in the department we cannot know how many would have agreed to participate in the study. Another obstacle in the present study, as is the case with most studies of patients with a high mortality rate, was the large number of drop-outs. Five of the seven patients that left the study before randomization declared that they were too physically and mentally exhausted after discharge to travel back to the hospital for baseline assessments and randomization. During the training period, three patients in the intervention group and one patient in the control group dropped out due to advanced cancer, and deceased later on. One of the patients who left the intervention group attended the 12 weeks of training but died before the assessments after the training period. One patient died during the longterm follow-up, also due to advanced cancer. Despite major surgery, approximately 50% of the patients died within five years after a radical cystectomy. However, there were no systematic biases due
to drop-outs. Because of the difficulties recruiting patients during the two-year study period and the many drop-outs, we decided to evaluate the results in this pilot study based on the existing number of patients. The small sample size could therefore cause Type II errors. According to Jones et al., surgery is the most common form of cancer therapy for solid tumours.19 Nevertheless, to our knowledge the effects of physical exercise after abdominal surgery have only been evaluated in one study (randomized controlled trial),20 where the highly intensive postoperative mobilization of all 119 participants could be one reason why no differences in physical function between the groups were observed. Such intensive mobilization would not have been appropriate for the seriously ill patients in this study. In the present study, both groups walked a longer distance after the 12 weeks, but the intervention group had improved more than the control group. This indicates that the patients who took part in the exercise programme benefitted from physical exercise shortly after discharge from hospital. However, even more interesting is the fact that one year after surgery, the patients in the intervention group had continued to improve the distance walked, whereas the patients in the control group had reduced it. According to the American Thoracic Society, no reliable reference values for the six-minute walk test have been reported.15 However, the clinical relevance of the increased physical function in the
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
457
Porserud et al. Table 4. Results after the training period and one year after surgery. Difference n Physical assessments 6MWT (m) T2–T1 T3–T2 Figure of T2–T1 eight (s) T3–T2 Steps T2–T1 outside (n) T3–T2 30-s chair T2–T1 stand test T3–T2 (n) SF-36 Physical T2–T1 functioning T3–T2 Role physical T2–T1 T3–T2 Bodily pain T2–T1 T3–T2 General T2–T1 health T3–T2 Vitality T2–T1 T3–T2 Social T2–T1 functioning T3–T2 Role T2–T1 emotional T3–T2 Mental T2−T1 health T3–T2 T2–T1 Physical health score T3–T2 Mental T2–T1 health score T3–T2
Intervention Median (range)
Control Mean (SD)
P-value
n
Median (range)
8 6 8 6 8 6 7 6
61.5 (36.0–119.0) 62.8 (26.3) −15.5 (−43.0–−4.5) −19.2 (15.3) −5 (−8.0–0.0) −4.6 (2.8) 3.8 (−4.0–6.0) 2.6 (3.6) 0.0 (−6.0–25.0) 3.1 (9.3) −0.5 (−5.0–3.0) −0.7 (2.7) 3.0 (0.0–4.0) 2.6 (1.6) 0.0 (−2.0–1.0) −0.3 (1.0)
5 4 5 4 5 4 5 4
109.0 (75.0–177.0) 112.9 (40.1) 20.0 (19.0–36.0) 23.8 (8.2) −2.0 (−75.0–0.0) −17.0 (32.5) 3.4 (0.2–22.0) 7.2 (10.0) −2.0 (−7.0–0.0) −2.0 (2.9) −1.5 (−4.0–5.0) −0.5 (4.0) 4.0 (0.0–6.0) 3.2 (2.3) 4.0 (−1.0–6.0) 3.3 (3.4)
5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4 5 4
25.0 (20.0–40.0) 28.0 (7.6) 8 5.0 (0.0–5.0) 3.8 (2.5) 6 100.0 (50.0–100.0) 90.0 (22.4) 8 −12.5 (−25.0–0.0) −12.5 (14.4) 6 22.0 (−10.0–43.0) 15.4 (22.0) 8 18.0 (16.0–59.0) 27.7 (20.9) 6 10.0 (−10.0–32.0) 11.8 (17.7) 8 −5.0 (−15.0–10.0) −3.7 (11.1) 6 25.0 (5.0–35.0) 25.0 (12.2) 8 2.5 (−5.0–10.0) 2.5 (6.5) 6 37.5 (0.0–37.5) 27.5 (16.3) 8 0.0 (0.0–25.0) 6.3 (12.5) 6 33.3 (0.0–100.0) 33.3 (40.8) 8 0.0 (0.0–33.3) 8.3 (16.7) 6 4.0 (0.0−24.0) 7.2 (10.0) 8 4.0 (0.0–8.0) 4.0 (4.6) 6 17.7 (11.0–22.8) 16.4 (5.0) 8 0.7 (−4.2–8.2) 1.4 (5.5) 6 5.4 (−6.7–20.9) 5.6 (10.0) 8 1.1 (−2.8–10.1) 2.4 (5.6) 6
22.5 (15.0–65.0) 5.0 (−25.0–15.0) 37.5 (0.0–100.0) 12.5 (−75.0–50.0) 2.0 (−30.0–69.0) 0.0 (−48.0–69.0) 6.0 (−31.3–27.0) −2.5 (−34.5–10.0) 20.0 (−18.3–45.0) −3.3 (−25.0–25.0) 6.3 (−37.5–37.5) 6.3 (−25.0–50.0) 0.0 (−100.0–100.0) 0.0 (−66.7−33.3) 12.0 (−20.0–44.0) 6.0 (−12.0–8.0) 10.4 (0.7–20.3) 2.9 (−19.7–9.6) 7.3 (−33.1–14.6) 1.4 (−11.1–9.9)
Mean (SD)
28.1 (17.3) 0.0 (15.2) 40.6 (44.2) 4.2 (43.1) 12.5 (34.0) 2.8 (39.2) 3.8 (20.1) −9.1 (17) 19.0 (21.4) −2.8 (17.7) 7.8 (25.8) 4.2 (28.1) 8.3 (55.6) 0.0 (36.5) 12.5 (22.4) 1.3 (9.0) 10.7 (6.3) −0.4 (10.8) 2.1 (16.0) 0.4 (8.1)
0.013 0.010 0.605 0.831 0.098 0.915 0.554 0.103 0.504 0.914 0.031 0.184 1.000 0.130 0.508 0.745 0.766 0.454 0.150 0.912 0.389 0.903 0.339 0.819 0.079 1.000 1.000 0.670
T1, Baseline assessments; T2, assessments after the training period within 14 weeks after baseline; T3, assessments one year after surgery. 6MWT, six-minute walk test.
intervention group is reflected in the improved SF-36 role physical domain. Patients who undergo major surgery are not expected to have a high health-related quality of life, but when comparing the patients in the present study to the general Swedish population aged 65
years and older, there are some interesting differences in the SF-36 scores.21 At baseline, the participants’ scores were lower than the 25th percentile of the matched population in five out of the eight SF-36 domains. The very low scores underline the importance of rehabilitation after a radical
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
458
Clinical Rehabilitation 28(5)
cystectomy. This conclusion is probably confirmed in a study from 2007 in which Karvinen et al. reported that out of 525 urinary bladder cancer survivors, of whom 20% had undergone a cystectomy, only 22% adhered to public health exercise guidelines.22 Furthermore, 16% exercised occasionally but insufficiently and 62% were completely sedentary. They concluded that although only a few of the patients adhered to the guidelines, exercise was positively associated with quality of life in urinary bladder cancer survivors. This first pilot study on the feasibility and effects of an early exercise training programme after an open radical cystectomy due to urinary bladder cancer gives rise to new research questions. Due to poor health status at discharge from hospital, all patients were not expected to be able to participate in an early exercise training programme, but the majority of the patients.. Unfortunately, due to shortcomings in routines for inviting patients to the study, we cannot show that the training programme was feasible for the patients. However, what is important is that those who took part benefitted from the programme in the short and long term. In order to achieve the best possible outcome, such patients should be offered training at a location close to their home as soon as their health allows it. It seems important to explore what kinds of exercise and intensity level benefit these patients the most, as well as where the exercise programme should be located. In view of the results of the study, at our hospital we now aim to improve the health-related quality of life of patients who have undergone a cystectomy due to urinary bladder cancer by providing individual guidance about physical exercise. Clinical messages •• A 12-week exercise training programme following radical cystectomy was not feasible in a majority of patients. •• For patients completing the exercise training programme in the intervention group, functional capacity and role physical domain of health-related quality of life increased in short and long term compared to controls.
Acknowledgements The authors wish to thank Ulrika Holdar for performing all the assessments with endless patience and enthusiasm and Lisbet Broman for her valuable assistance with the statistical analyses.
Conflict of interest The author declares that there is no conflict of interest.
Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
References 1. Roychowdhury DF, Hayden A and Liepa AM. Healthrelated quality-of-life parameters as independent prognostic factors in advanced or metastatic bladder cancer. J Clin Oncol 2003; 21: 673–678. 2. Stull VB, Snyder DC and Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr 2007; 137(suppl): 243S–248S. 3. Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: longterm results in 1,054 patients. J Clin Oncol 2001; 19: 666–675. 4. Oosterlinck W, Lobel B, Jakse G, Malmstrom PU, Stockle M and Sternberg C. Guidelines on bladder cancer. Eur Urol 2002; 41: 105–112. 5. Stenzl A, Cowan NC, De Santis M, et al. Treatment of muscle-invasive and metastatic bladder cancer: update of the EAU guidelines. Eur Urol 2011; 59: 1009–1018. 6. Kulaksizoglu H, Toktas G, Kulaksizoglu IB, Aglamis E and Unluer E. When should quality of life be measured after radical cystectomy? Eur Urol 2002; 42: 350–355. 7. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993; 85: 365–376. 8. Warburton DE, Nicol CW and Bredin SS. Health benefits of physical activity: the evidence. Cmaj 2006; 174: 801–809. 9. Galvao DA and Newton RU. Review of exercise intervention studies in cancer patients. J Clin Oncol 2005; 23: 899–909. 10. Ingram C and Visovsky C. Exercise intervention to modify physiologic risk factors in cancer survivors. Semin Oncol Nurs 2007; 23: 275–284. 11. Knols R, Aaronson NK, Uebelhart D, Fransen J and Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
459
Porserud et al. of randomized and controlled clinical trials. J Clin Oncol 2005; 23: 3830–3842. 12. Jones LW and Courneya KS. Exercise discussions during cancer treatment consultations. Cancer Pract 2002; 10: 66–74. 13. Stevinson C and Fox KR. Role of exercise for cancer rehabilitation in UK hospitals: a survey of oncology nurses. Eur J Cancer Care (Engl) 2005; 14: 63–69. 14. Bricker EM. Bladder substitution after pelvic evisceration. Surg Clin North Am 1950; 30: 1511–1521. 15. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166: 111–117. 16. Frändin K, Sonn U, Svantesson U, et al. Functional balance tests in 76-year-olds in relation to performance, activities of daily living and platform tests. Scand J Rehabil Med 1995; 27: 231–241. 17. Jones CJ, Rikli RE and Beam WC. A 30-s chair-stand test as a measure of lower body strength in communityresiding older adults. Res Q Exerc Sport 1999; 70: 113–119.
18. Sullivan M, Karlsson J and Ware JE, Jr. The Swedish SF-36 Health Survey – I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med 1995; 41: 1349–1358. 19. Jones LW, Peppercom J, Scott JM and Battaglini C. Exercise therapy in the management of solid tumors. Curr Treat Options Oncol 2010; 11: 45–58. 20. Houborg KB, Jensen MB, Rasmussen P, Gandrup P, Schroll M and Laurberg S. Postoperative physical training following colorectal surgery: a randomised, placebo-controlled study. Scand J Surg 2006; 95: 17–22. 21. Sullivan M, Karlsson J and Taft C. SF-36 Hälsoenkät: Swedish manual and interpretation guide, second edition. Gothenburg: Sahlgrenska University Hospital, 2002. 22. Karvinen KH, Courneya KS, North S and Venner P. Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Cancer Epidemiol Biomarkers Prev 2007; 16: 984–990.
Downloaded from cre.sagepub.com at University of Bath - The Library on June 14, 2015
