Virtual Reality Versus Conventional Exercise Intradialysis

Study Overview
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Brief Summary
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All participants exercised during 16 weeks following a conventional intradialysis exercise program. The last 4 weeks of the study participants were randomized into two different exercise programs intradialysis. One group exercised through a virtual reality exercise adapted specially for patients while receiving hemodialysis treatment. The other group exercised with a conventional exercise program, combining aerobic cycling and strengthening exercises.

Detailed Description
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The first 16 weeks all participants followed an intradialysis exercise program. The exercise program consisted of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program included isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands were used to apply resistance. Progression was achieved from increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part lasted no more than 30 minutes. The program also included aerobic exercise (cycling) for up to 30 minutes. Intensity was adapted through the duration of the study so that the participant felt the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance were adapted progressively. The last four weeks of the program participants were randomized into virtual reality exercise or conventional exercise group. The virtual reality exercise group undertook 30 minutes of exercise. After warming up, participants had to play to an adapted 'treasure hunt' game. Their legs movements were the players projected into an individual tv that gave them feedback regarding their achievements. The aim of the game was to achieve the higher possible score.They moved to pick up coins and to avoid bombs. An adapted Kinect technology was used for the game development.

Official Title
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Comparison of Two Exercise Programs Intradialysis: Virtual Reality Exercise Versus Conventional Exercise

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Virtual Reality Exercise
* Other: Conventional exercise intradialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients in HD therapy at least 3 months Exclusion Criteria: recent myocardial infarction (within 6 weeks) unstable angina malignant arrhythmias above the knee amputation without replacement cerebral vascular disease (ictus, transient ischemia) musculoskeletal and respiratory disorders that can get worse with exercise impossibility to achieve functional testing

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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtural reality exercise<br>Virtual reality exercise performed during the hemodialysis session, using the Kinect, specially adapted for patients undertaking hemodialysis | Other: Virtual Reality Exercise<br>* Game developed by the Kinect, adapted to the lying position of participants.<br>|
| Active Comparator: Conventional exercise intradialysis<br>Exercise combining both aerobic (cycling) and strengthening exercise of lower limbs for patients during the hemodialysis session | Other: Conventional exercise intradialysis<br>* Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit to Stand to Sit test 10 | Time required to stand up from a chair and sit down 10 consecutive times | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery | Balance, gait speed and sit to stand to sit 5 times | 20 weeks | 
| Timed Up and Go | Time to stand up, walk a short distance, turn, walk back and sit down to the chair again | 20 weeks | 
| One leg stand test | Time to keep balance on one leg | 20 weeks | 
| Sit to Stand to Sit test 60 seconds | Number of repetitions achieved of standing up from a chair during 60 seconds | 20 weeks | 
| Handgrip | Handgrip strength right and left hands | 20 weeks | 
| One leg heel rise test | Number of repetitions of standing on toes in both legs | 20 weeks | 
| 6 minutes walk test | Number of meters covered during 6 minutes of walking | 20 weeks | 
| Adherence | Sessions performed/offered | 20 weeks | 
| Physical Activity | Human activity profile, adjusted and maximal activity score | 16 weeks | 
| Physical Activity | Physical activity score for the elderly | 16 weeks | 
| Inflammatory markers | Interleukin 6 (IL6) | 16 weeks | 
| Inflammatory markers | Monocyte chemoattractant protein-1 (MCP-1) | 16 weeks | 
| Inflammatory markers | C-Reactive Protein (CRP) | 16 weeks | 
| Inflammatory markers | Human Tumor Necrosis Factor α (TNF-α) | 16 weeks | 
| Health-related quality of life | SF-36 subscales and components | 16 weeks | 
| Oxidative stress markers | Malondialdehyde (MDA) | 16 weeks | 
| Oxidative stress markers | Carbonylated proteins | 16 weeks | 

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