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Geriatr Gerontol Int 2016; 16: 492–499

ORIGINAL ARTICLE: EPIDEMIOLOGY, CLINICAL PRACTICE AND HEALTH

Effects of two physical exercise protocols on physical performance related to falls in the oldest old: A randomized controlled trial Juliana Hotta Ansai, Thais Rabiatti Aurichio, Raquel Gonçalves and José Rubens Rebelatto Postgraduate Program of Physiotherapy, Federal University of São Carlos, São Carlos, Brazil

Aim: To compare the effects of 16-week multicomponent and resistance training, and 6-week detraining on physical variables related to a higher risk of falls in very old people. Methods: A randomized, three-arm, controlled trial was carried out. A total of 69 community-dwelling older adults aged 80 years and older were allocated to three groups: control, multicomponent training and resistance training. They were assessed at baseline, after 16-week training and 6-week detraining. The control group did not perform any intervention. The multicomponent group performed protocol consisting of warm-up, aerobic, strength, balance and cool-down exercises. The resistance group underwent strength exercises using six adapted machines. The training sessions had progressive intensity, lasted 16 weeks and 12 included three 1-h sessions per week. The assessment consisted of anamneses, five-repetition sit-to-stand, one-leg standing, tandem and dual task tests. For statistical analysis, α = 0.05 was used. Results: There were no significant differences between groups and assessments in any variable when analyzed by intention to treat. However, when analyzed, the older adults who adhered to the training, the multicomponent group, had a significant improvement in the sit-to-stand and the one-leg standing (right support) tests. There was a significant main effect between times on the one-leg standing (left support) test. Conclusion: In very old people, multicomponent training seems to be more beneficial and presents fewer adverse events when the adherence to protocol is higher. Geriatr Gerontol Int 2016; 16: 492–499. Keywords: exercise, falls, oldest old, postural balance, randomized controlled trial.

Introduction People aged over 85 years are more vulnerable to multiple chronic conditions and disabilities, therefore concerns about healthcare are increasing in this age group.1 Haber et al. found that balance, lower limb strength and gait in healthy community-dwelling women are maintained until 45–55 years-of-age.2 After this age, there is a non-linear relationship between increasing age and deterioration of these abilities. Falkner et al. reported that after 80 years-of-age, approximately 50% of the

Accepted for publication 22 February 2015. Correspondence: Master Juliana Hotta Ansai MD, Physiotherapy Department, Washington Luiz highway, 235 km, postal code 13565-905, São Carlos, Brazil. Email: [email protected] Permanent address: Physiotherapy Department, Washington Luiz highway, 235 km, postal code 13565-905, São Carlos, Brazil.

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doi: 10.1111/ggi.12497

muscle fibers of the lower limbs are lost.3 In addition, physical and functional limitations, and advanced age are important risk factors for falls.4 To prevent or compensate motor changes and maintain functionality in the elderly, the effectiveness of different protocols of physical activity have been studied.5 Forte et al. compared multicomponent training and resistance training in older adults.6 After 3 months, there were improvements in both forms of training on gait speed (normal gait and associated with a motor task), but only resistance training improved lower limb strength. However, Gillespie et al. suggested that multicomponent training is more effective in reducing the risk of falls in older adults than other forms of training.7 Additionally, multicomponent training is recommended by the American College of Sports in Medicine to improve and maintain physical function in the elderly.8 None of the aforementioned studies verified the effects of different forms of training in those aged over 80 years. © 2015 Japan . . Geriatrics Society

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Although studies report that physical exercise helps mitigate the physiological effects of aging, there is insufficient evidence on which protocols are recommended more for factors related to falls in those aged over 80 years.9–11 The purpose of the present study was to compare the effects of 16-week multicomponent and resistance training programs on physical variables related to a higher risk of falls, and the fall rate in community-dwelling oldest-old people. Furthermore, the same variables were analyzed after 6 weeks of detraining. It was hypothesized that there would be improvements for both training programs after the intervention, but with higher benefits for the multicomponent training. After detraining, a trend in worsening performance in both intervention groups would be expected.

Materials and methods Study design A randomized, three-arm, controlled trial was carried out at the Federal University of São Carlos (UFSCar, São Paulo, Brazil; Clinical Trials Registration ID: NCT01983397). The study was approved by the UFSCar Ethics Research Committee (ID: 72053/2012). All participants signed the informed consent form.

Participants and randomization Participants were recruited through telephone contact among older adults from health centers and the Open University for older adults (São Carlos-SP). In addition, the study was disclosed by flyers, radio channels and local television. The inclusion criteria were being aged over 80 years, community-dwelling individual, sedentary, able to walk alone and reported availability to come to the training site three times a week. The exclusion criteria were the presence of any injury listed in the absolute contraindications of the Physical Activity Readiness Medical Examination; relative cognition, neurological or skeletal muscle contraindications, which made participation in protocols impossible; and a Mini-Mental State Examination score below the cut-off designated by educational level minus one standard deviation.12 Initially, there were 570 eligible older adults. Of these, 69 met the inclusion criteria and were randomized into three groups (control [CO], multicomponent training [MT] or resistance training [RT]) after initial assessment (n = 23 per group) by a computerized random-number generator, with blocks of variable sizes (3, 6, 9). All randomizations were concealed. The process of randomization was carried out by a researcher not affiliated with the study. According to the sequence of randomization, each volunteer corresponded to an opaque and © 2015 Japan Geriatrics Society

sealed envelope, which contained a card stating which group the volunteer would be allocated to. The envelopes were opened after the first evaluation.

Interventions The CO group did not carry out any intervention. The MT and RT groups underwent a 1-week familiarization period. The training lasted 16 weeks and included three 1-h sessions per week on non-consecutive days. The same researcher who carried out the assessment monitored the interventions with help from trained physical educators. After the intervention period, the participants underwent a 6-week detraining period. There was no guidance during the detraining phase.

MT group Each MT session had the following structure: 5 min of warm-up using a cycle ergometer; 13 min of aerobic exercise using a cycle ergometer; 15–20 min of strength exercises of major muscle groups (diagonal upper limb, abdominal, squat and ankle strengthen); 10 min of balance activities; and 5 min of cool-down exercise (stretching of the major muscle groups and deep breathing). The aerobic exercise intensity ranged from 60 to 85% reserve heart rate, adjusted by age and sex.9 We used an interval protocol with increased and decreased intensity every 3 min.13 The reserve heart rate progression was increased every 3 weeks. The intensity of strength exercises ranged from 14 to 17 on the Borg conventional scale (6–20).14 Progression was carried out by increasing repetitions (up to 15), series (up to three) and incremental load of 1 kg. Balance exercises included static balance, dynamic and static weight transfer, walking on a line, walking on unstable surfaces, obstacle transposition, and deviation. The difficulty level was gradually increased if the volunteer could carry out exercises properly through reducing sensory inputs, reducing the support base, increasing the complexity of movements and adding motor/ cognitive tasks to disturb their center of gravity.

RT group Six machines adapted for older adults were used for the RT group: leg press, chest press, calf, back extension, abdominal and rowing. The participants carried out three sets of 10–12 maximal repetitions at moderate speed (2 s for the concentric phase and 3 s for the eccentric phase) and 1-min resting periods between sets. The participants carried out the first two sets of 12 repetitions and the third set until fatigue. The load was adjusted so that fatigue occurred between the 10th and | 493

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12th repetition of the third set.15 The upper and lower limbs exercises were interspersed during training.

Measures The volunteers were assessed at baseline, after training and after detraining. Descriptive variables were assessed using a questionnaire at baseline and the volunteers were asked about falls in the past 3 months.16

Physical performance outcomes Muscle strength of the lower limbs was assessed through the five-repetition sit-to-stand test, and the time spent was noted (in seconds).17 The one-leg standing and tandem tests were used to assess balance. In both tests, the participants were instructed to keep their eyes opened, have bare feet, keep their arms alongside their body and stare at a reference point 1 m away. The one-leg standing and the tandem tests were carried out as described by Michikawa et al.18 and El-Sobkey,19 respectively. The dual task was assessed using the Timed Up and Go test (TUGT) at a normal pace while carrying a full cup of water (TUGT-motor), as described by Hofheinz and Schusterschitz.20 A total of 10 volunteers used a cane to walk, and the test was carried out with a cane. A pretest was carried out for familiarization with a 1-min interval between attempts.

Fall outcomes After baseline assessment, the volunteers received a fall calendar, which should be completed until the end of the study. Once a month, they were asked about falls by phone or during days of training.

to carry out a comparative analysis. The MANOVA test was used to verify interaction and differences between groups and assessments. If a significant interaction was identified, analyses of simple main effects by group and post-hoc (Tukey test) tests were carried out. Because of the low adherence to training sessions, in addition to the analysis by intention to treat, differences were analyzed at baseline among the CO group and people who adhered (attended at least 24 sessions for 16 weeks) or not to training sessions using one-way ANOVA and χ2-tests. The MANOVA test was used to verify the interaction and differences between the participants who adhered in the MT, RT and CO groups, and the assessments.

Results After 16 weeks from the baseline, all volunteers were re-evaluated, except one individual from the MT group who refused to participate. After the detraining phase, three elderly individuals from the CO group did not carry out the assessment (one because of failure to contact and two because of refusal; Fig. 1). Table 1 shows the major sociodemographic characteristics of the sample. There were no differences between groups for the sociodemographic characteristics, except for the percentage of osteoarthritis, which was higher in the MT group and lower in the CO group. All volunteers were independent in basic activities of daily living. Among participants who reported falls in the previous 3 months, there was no difference between groups regarding the number, location or consequences of falls (52% reported any consequences). There was an average of 1.1 falls.

Adherence to treatment Statistical analysis The sample size was calculated using G*Power 3.1 software (Universität Düsseldorf, Düsseldorf, Germany). Assuming the type of study design (MANOVA), type I error at 5%, statistical power at 80% and an effect size of 0.4, a minimum of 66 participants should constitute the total sample. For analysis, a significance level of α = 0.05 was used, and SPSS software was used (version 17.0; SPSS, Chicago, IL, USA) to run the tests. The analysis was carried out by intention to treat. Rejecting the normality hypothesis, the z-score calculation was used to standardize quantitative data. Descriptive analysis was carried out using the χ2-test of association and the one-way ANOVA. The χ2-test of association was used to verify differences in the frequency of fallers between groups and between the first two assessments. Because of the low frequency of loss of water in the TUGT-motor test, it was not possible 494 |

Overall, 34.7% of the MT group and 56.5% of the RT group carried out at least 24 sessions for 16 weeks (half of the intervention). The reasons for not participating or participating in less than one-quarter of the sessions for the MT group were transportation problems (n = 3), personal health problems (n = 6), spouse health (n = 4) and refusal to participate (n = 1). Possible adverse effects were mild muscle pain (n = 4), mild hematoma (n = 1) and dizziness (n = 1). The reasons for participating in less than one-quarter of the sessions for the RT group were personal health problems (n = 3) and refusal to participate (n = 2). Possible adverse effects were mild muscle pain (n = 9). At baseline, the participants who adhered in the MT group carried out the sit-to-stand test significantly slower (mean = 25.1 s [3.9 s]) than the participants who adhered in the RT group, those who did not adhere in the MT group and those in the CO group. The © 2015 Japan Geriatrics Society

Exercises protocols in oldest old

Assessed for elegibility (n=570)

Excluded (n=501)  Not being sedentary (n=26)  Health problems/Problemas de saude/unable to walk alone (n=145)  Low MMSE score (n=6)  Difficulty in transport/long distance (n=109)  Unavailability related to spouse health (n=14)  Refusal to participate for other reasons (n=201)

Randomized (n=69)

Allocated to MT (n=23)  Received at least a quarter of allocated intervention (n=9) -difficulty in transport (n=3) -health problems (n=6) -spouse health (n=4) -refusal to participate (n=1)

Allocated to CO (n=23)

Allocated to RT (n=23)  Received at least a quarter of allocated intervention (n=18)  Received less than a quarter/did not received allocated intervention: -health problems (n=3) -refusal to participate (n=2)

Post intervention (16 weeks)

 

Analyzed (n=22) Lost to follow-up (refusal to participate) (n=1)





Analyzed (n=23)

Analyzed (n=23)

Detraining (6 weeks)





Analyzed (n=22)

Analyzed (n=23)

 

Analyzed (n=20) Lost to follow-up: -refusal to participate (n=2) -failure to contact (n=1)

Figure 1 Participants’ flowchart. CO, control group; MMSE, Mini-Mental State Examination; MT, multicomponent training group; RT, resistance training Group.

Table 1 Descriptive data Variable

Total (n = 69)

Control group (n = 23)

Multicomponent group (n = 23)

Resistance group (n = 23)

P-value

Mean age, years (SD) Female, n (%) Mean body mass index, kg/m2 (SD) Mean educational level (SD) Not using walking aid, n (%) Not wearing bi/multifocal glasses No complaint of dizziness Mean no. medications (SD) Diseases Mean total n, (SD) Diabetes, n (%) Hypertension, n (%) Osteoarthritis, n (%) Depression, n (%) Fall in the past 3 months, n (%) Mean MMSE, 0–30 (SD)

82.4 (2.4) 47 (68.1) 28.1 (4.5) 4.7 (5.2) 57 (82.6) 49 (71) 50 (72.4) 3.8 (2.3)

82.6 (2.6) 15 (65.2) 27.5 (4) 5.6 (5.2) 22 (95.6) 18 (78.2) 18 (78.2) 3.4 (2.6)

81.9 (1.9) 17 (73.9) 28 (5) 3.3 (3) 16 (69.5) 14 (60.8) 16 (69.5) 3.9 (2.2)

82.8 (2.8) 15 (65.2) 28.8 (4.6) 5.4 (6.8) 19 (82.6) 17 (73.9) 16 (69.5) 4.1 (2.2)

0.412 0.766 0.641 0.255 0.219 0.612 0.862 0.607

3.6 (1.9) 16 (23.2) 47 (68.1) 30 (43.5) 12 (17.4) 25 (36.2) 24.9 (3.3)

3.4 (2.6) 5 (21.7) 15 (65.2) 4 (17.4)† 2 (8.7) 8 (34.8) 25.3 (3.5)

3.7 (1.8) 6 (26.1) 18 (78.3) 16 (69.6)† 5 (21.7) 10 (43.5) 24.3 (3.3)

3.7 (1.3) 5 (21.7) 14 (60.9) 10 (43.5) 5 (21.7) 7 (30.4) 25.1 (3.4)

0.837 0.922 0.420 0.002** 0.403 0.645 0.603

**P < 0.01 (χ2 = 12.73), †Residual adjustment ≥2 (multicomponent group tended to have osteoarthritis and control group tended not to have osteoarthritis). MMSE, Mini-Mental State Examination; SD, standard deviation.

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25.3 (9.3) 2 (10.0) 24.7 (6.9) 5 (25) 28.0 (15.2) 2 (8.7) 25.8 (7.0) 8 (34.8) 25.3 (8.4) 1 (4.3) 24.9 (5.1) 8 (34.8) 26.7 (22.2) 1 (4.3) 26.9 (14.0) 1 (4.3) 28.1 (15.3) 0 (0) 27.6 (13.4) 8 (34.8) 29.0 (15.5) 2 (8.7) 27.7 (12.1) 7 (30.4) 31.1 (22.8) 0 (0) 27.0 (9.2) 4 (18.2) 30.4 (12.2) 0 (0) 26.4 (7.2) 10 (43.5)

29.8 (13.1) 1 (4.5) 27.2 (9.7) 2 (9.1)

18.7 (11.9) 17.6 (12.3) 16.5 (11.6) 18.2 (12.8) 20.6 (12.2) 18.3 (11.6) 17.9 (12.7) 17.3 (12.9)

19.8 (13.1)

7.0 (7.7) 5.5 (7.1) 5.4 (6.0) 7.9 (8.1) 7.4 (7.1) 6.6 (7.7) 10.7 (11.0) 10.3 (11.2) 8.7 (10.5)

16.4 (5.4) 4.9 (8.0) 16.0 (4.7) 5.1 (6.5) 15.0 (7.3) 6.7 (7.4) 16.2 (6.4) 7.0 (7.0) 18.1 (8.8) 6.0 (6.7) 16.1 (5.1) 11.1 (11.7)

Data presented as mean (standard deviation). P > 0.05 for all analyses between groups and assessments. DT, detraining; TUGT, Timed Up and Go Test.

Discussion

15.8 (7.7) 10.9 (11.8)

The volunteers were instructed to deliver the fall calendar at the third assessment. However, 25 volunteers did not deliver the calendar and four calendars were not delivered because of sample loss. The results obtained from the calendars and the calls were compatible in 31 of the elderly individuals, but one volunteer noted more falls on the calendar and eight volunteers reported more falls during the calls. Thus, we used only the data obtained from the calls for analysis. There was no difference in the frequency of fallers between groups or between the first and the second assessments. However, we verified a clinically relevant decrease in the frequency of fallers between assessments in the MT group (Table 2). Among people who adhered in the interventions, there was no significant difference in the frequency of fallers.

Table 2 Physical performance and fall outcomes

Fall outcomes

Multicomponent group Baseline 16 weeks (n = 23) (n = 22)

6 weeks of DT (n = 22)

Resistance group Baseline 16 weeks (n = 23) (n = 23)

6 weeks of DT (n = 23)

Five elderly participants from the CO group, two from the MT group and one from the RT group were not entered into the analysis of the sit-to-stand performance (four older adults did not participate in any assessment and four older adults failed to carry out the test). Table 2 shows the performance of groups at each assessment on the physical tests. There was no significant interaction between group and assessment for any variable. There was no significant main effect for groups or assessments by intention to treat. Although the MT group presented a growing improvement in the one-leg standing test (right support), this change was not statistically significant. When analyzing the older adults who adhered to the interventions, there was a significant interaction between groups and assessments in the sit-to-stand (F = 5.316, P = 0.001) and the one-leg standing (right support) (F = 5.780, P < 0.001) tests. The MT group had a significant improvement in the sit-to-stand and the one-leg standing (right support) tests between the first and second assessments, and between the first and the third assessments. There was a significant main effect between times regarding the one-leg standing (left support) test (P = 0.035; Table 3, Fig. 2).

18.9 (8.6) 7.1 (8.6)

Physical performance outcomes

Sit-to-stand (s) One-leg standing (right support), s (0–30) One-leg standing (left support), s (0–30) Tandem, s (0–30) TUGT-motor Time, s Loss of water, n (%) No. steps Report of falls, n (%)

Control group Baseline 16 weeks (n = 23) (n = 23)

6 weeks of DT (n = 20)

percentage of osteoarthritis was higher for volunteers who adhered (75%) than for those who did not (69%) in the MT group, and lower for the CO group (17.4%). Other baseline variables did not differ between the subgroups.

15.5 (6.3) 5.5 (5.9)

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© 2015 Japan Geriatrics Society

Groups of adherence to resistance training (n = 13), multicomponent training (n = 8) and control (n = 20) groups. †Analysis between resistance training (n = 12), multicomponent training (n = 8) and control (n = 18). TUGT, Timed Up and Go Test.

>0.05 >0.05 5.3 (−5.5–16.3) 4.3 (−3.4–12.0)

– – −2.0 (−11.4–7.2) −1.9 (−8.5–4.6) −7.4 (−19.2–4.3) −6.2 (−14.6–2.0)

0.05 5.316 5.780 – – −1.3 (−5.8–3.1) 3.5 (−3.1–10.1) 3.5 (−2.5–9.6) 1.8 (−8.0–11.7) −3.8 (−9.4–1.6) −0.1 (−8.5–8.2) 2.2 (−5.4–9.8) 0.7 (−11.6–13.2)

Sit-to-stand (s)† One-leg standing (right support), s (0–30) One-leg standing (left support), s (0–30) Tandem, s (0–30) TUGT-motor Time (s) Loss of water, n (%)

2.5 (−2.5–7.6) 3.6 (−4.1–11.4) 1.2 (−5.8–8.4) 1.0 (−10.5–12.6)

F2.35 value Absolute mean difference between groups (confidence interval 95%) Resistance group – Resistance group – Multicomponent group – multicomponent group control group control group

Table 3 Physical performance outcomes between adherence groups

P-value

Exercises protocols in oldest old

training protocols on physical variables related to risk of falls in community-dwelling people aged over 80 years. Furthermore, the same variables were analyzed after a 6-week detraining period. In the analysis by intention to treat, no significant differences between groups and assessments were found for any variable. When analyzing the older adults who adhered in the interventions, the MT group had a significant improvement in the sit-to-stand and the one-leg standing (right support) tests between the first and second assessments, as well as between the first and the third assessments. There was a significant main effect of assessments in the oneleg standing (left support) test, with a tendency to improve from the first to the second assessment. Other studies found some positive effects of multicomponent training on strength, balance and rate of falls, analyzed by no intention to treat.21,22 Clemson et al. found that home multicomponent training integrated with daily activities was effective in increasing static balance and decreasing the rate of falls in elderly fallers (mean age 83 years).22 Thus, a multicomponent protocol could effectively improve physical performance in people aged over 80 years. Additionally, some studies found positive effects of resistance training on strength and balance.23,24 Caserotti et al. found that community-dwelling people aged over 80 years who underwent resistance training with high intensity showed similar improvements on the muscle strength of their lower limbs compared with people aged between 60 and 65 years.24 The aforementioned studies did not analyze data by intention to treat, and had a greater adherence to training, which could have accounted for the discrepancies of results. Physical performance was maintained between the short detraining phase and after the MT protocol. Other studies also found positive changes in the detraining phase after multicomponent training on the dual task and sit-to-stand tests compared with baseline.11,25 Toraman and Ayceman analyzed responses to detraining after only a 9-week training protocol.26 In people aged over 80 years, there was a worsening in the performance of the sit-to-stand test after the 2-week detraining. After the 6-week detraining, the performance of TUG declined, but strength gains were maintained compared with baseline. By comparing the results of the present study, we suggest that a long training period (≥16 weeks) is enough to maintain physical benefits for more than 2 months, regardless of the type of training used. Serra-Rexach et al. studied the effects of 8-week training focused on strength in institutionalized nonagenarian people.27 After a 4-week detraining period, the gains in strength of the lower limbs and the TUG, and the decreases in the number of falls were maintained. However, Kalapotharakos et al. found that a 6-week detraining protocol led to a decrease in performance on | 497

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Figure 2

Strength and balance performance outcomes between adherence groups. *P < 0.05, **P < 0.01.

the TUG and sit-to-stand tests in the elderly individuals aged over 80 years who underwent 8-week resistance training.28 Intensity and duration of training as well as the previous physical condition of people who underwent training could be decisive for outcomes after detraining. We did not identify any significant change in the frequency of falls, but there was a clinically relevant decrease after the MT training. Gillespie et al. suggested multicomponent exercise protocols and home safety interventions to reduce the rate of falls.7 People aged over 80 years could require a combination of interventions to reduce the incidence of falls, because this event is multifactorial. Still, they suggested that falls should be recorded daily and monitored monthly. Hannan et al.29 and Fleming et al.30 suggested the calendar was the preferred method for screening falls. However, the present study did not have good adherence to the calendar, perhaps because of differences in the methods of screening and the sample’s level of education. This study presents some limitations, such as lack of blinding, high standard deviations of variables because 498 |

of the diversity of the older adults aged over 80 years, difference in sit-to-stand performance between the subgroups of adherence, and poor adherence to the fall calendar and training, especially in the MT group. The RT group used the same space as the younger elderly participants who practiced physical exercise, had more social contact and a better view of the benefits of physical activity, which could have influenced the difference in the adherence between the groups. Literature involving only older adults aged over 80 years and analyzing data by intention to treat is limited, which makes comparison of the results difficult. Nevertheless, the authors used tests with less risk of adverse events that were more functional and focused on clinical practice. This study presented new information about the effects of physical activity and a detraining phase in elderly individuals aged over 80 years on variables related to a higher risk of falls. No significant differences between training and assessments were found in any variable related to the risk of falls. However, multicomponent training seems to be more beneficial and present fewer adverse events © 2015 Japan Geriatrics Society

Exercises protocols in oldest old

when the adherence to protocol is higher. There is a need for new approaches regarding dosages and components of interventions as well as new studies to determine how long the benefits of exercise can be maintained in older adults aged over 80 years.

Disclosure statement No potential conflicts of interest were disclosed.

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Effects of two physical exercise protocols on physical performance related to falls in the oldest old: A randomized controlled trial.

To compare the effects of 16-week multicomponent and resistance training, and 6-week detraining on physical variables related to a higher risk of fall...
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