Virtual Reality Intradialysis: Last vs. First Part of the Session

Study Overview
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Brief Summary
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The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session. The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.

Detailed Description
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Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months. The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.

Official Title
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Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session

Conditions
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End Stage Renal Disease on Dialysis, Hemodialysis Complication

Intervention / Treatment
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* Other: Conventional exercise
* Other: Exercise during the last two hours of the hemodialysis session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 months in hemodialysis treatment Clinically stable Exclusion Criteria: Recent cardiac events (less than 3 months) Unable to exercise

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, during the first two hours of hemodialysis or during the last two hours of hemodialysis
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional exercise time<br>During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented | Other: Conventional exercise<br>* Virtual reality exercise performed during the first two hours of the hemodialysis session<br>|
| Experimental: Experimental group<br>During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented | Other: Exercise during the last two hours of the hemodialysis session<br>* Virtual reality exercise performed during the last two hours of the hemodialysis session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 3 Months | 
| Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 6 Months | 
| Number of hypotension episodes | Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months | Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage. | Baseline and 3 months | 
| Change from baseline dialysis dose at 3 months, 6 months, and 12 months | Dialysis dose, measured through Kt/V | Baseline, 3 Months, 6 months and 12 months | 
| Adherence, as number of sessions performed /number of sessions offered | Sessions performed/sessions offered | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline short physical performance battery at 3 months, 6 months, and 12 months | 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, 3 Months, 6 months and 12 months | 
| Change from baseline gait speed at 3 months, 6 months, and 12 months | Speed to cover 4 meters, in meters/second | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline handgrip at 3 months, 6 months, and 12 months | Bilateral handgrip strength | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months | Muscle strength measured with a handheld dynamometer on the main muscle groups during hemodialysis | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline one-leg standing test at 3 months, 6 months, and 12 months | Time achieved while standing on one leg | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months | Time to perform 10 repetitions sit to stand | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months | Sit to stand repetitions performed in 60 seconds | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline timed up and go at 3 months, 6 months, and 12 months | Time to stand up, walk 3 meters, come back and sit down again | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months | Number of heel rise repetitions achieved | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months | Number of meters walked in 6 minutes | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline Physical activity level at 3 months, 6 months, and 12 months | Physical activity questionnaires | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline Health related quality of life at 3 months, 6 months, and 12 months | 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, 3 Months, 6 months and 12 months | 
| Change from baseline Cognitive function at 3 months, 6 months, and 12 months | Mini-mental State Examination questionnaire, score ranges from 0 to 30, higher scores indicates higher cognitive function | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months | Functional evaluation by Barthel Index, to evaluate capacity to perform daily tasks without assistance. Score ranges from 0 to 100. Higher scores indicates higher capacity to perform activities. | Baseline, 3 Months, 6 months and 12 months | 
| Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months | Frailty will be measured from 0 to 5, depending on how many of the 5 components are present in each subject, being 5 the highest frailty score | Baseline, 3 Months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Virtual reality, physical function, health-related quality of life, hemodynamic instability