Home-based vs Intradialysis Exercise Guided by Nursing Staff

Study Overview
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Brief Summary
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Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.

Detailed Description
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During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program. The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.

Official Title
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Home-based vs Intradialysis Exercise Program Guided by Nursing Staff

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Other: Intradialysis exercise training
* Other: Home-based exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months Exclusion Criteria: Myocardial infarction in the previous 6 weeks Angina unstable on exercise or at rest Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia. Life expectancy less than 6 months Cognitive impairment Language barriers Illiteracy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into one of two exercise groups, intradialysis or home-based program
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradialysis exercise guided by nursing staff<br>During 16 weeks subjects will exercise during the hemodialysis session, the exercise will include both aerobic and resistance training. Guidance will be provided by nursing staff | Other: Intradialysis exercise training<br>* Combined exercise, aerobic and resistance training, implemented by nursing staff<br>|
| Active Comparator: Home-based exercise program<br>During 16 weeks subjects will exercise on their own at home. A booklet will be provided, with a diary. Instructions to do resistance exercise with intervals of walking will be provided. Initial training will be provided by physiotherapy staff from the hospital. | Other: Home-based exercise training<br>* Combined exercise, aerobic and resistance training, implemented independently home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline short physical performance battery at 16 weeks | Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score | Baseline, 16 weeks | 
| Change from baseline gait speed at 16 weeks | Speed to cover 4 meters, in meters/second | Baseline, 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline sit to stand 10 test at 16 weeks | Time to perform 10 repetitions sit to stand | Baseline, 16 weeks | 
| Change from baseline sit to stand 60 test at 16 weeks | Sit to stand repetitions performed in 60 seconds | Baseline, 16 weeks | 
| Change from baseline 6 minutes walk test at 16 weeks | Number of meters walked in 6 minutes | Baseline, 16 weeks | 
| Change from baseline handgrip strength at 16 weeks | Bilateral handgrip strength | Baseline, 16 weeks | 
| Change from baseline one-leg heel rise test at 16 weeks | Number of heel rise repetitions achieved | Baseline, 16 weeks | 
| Change from baseline one-leg standing test at 16 weeks | Time achieved while standing on one leg | Baseline, 16 weeks | 
| Change from baseline timed up and go test at 16 weeks | Time to stand up, walk 3 meters, come back and sit down again | Baseline, 16 weeks | 
| Change from baseline Physical activity level at 16 weeks | Physical activity questionnaires | Baseline, 16 weeks | 
| Change from baseline Health related quality of life at 16 weeks | Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life | Baseline, 16 weeks | 
| Adherence, as number of sessions performed /number of sessions offered | Sessions performed/sessions offered | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Hemodialysis