Virtual Reality During Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

Detailed Description
-----------------
Participants will be randomized into one of two groups. The first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. The second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks. 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 the game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

Official Title
-----------------
Virtual Reality Exercise During Hemodialysis

Conditions
-----------------
End Stage Renal Disease, Hemodialysis-Induced Symptom

Intervention / Treatment
-----------------
* Other: Virtual reality exercise during hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will receive during hemodialysis the conditions 'virtual reality exercise' for 12 weeks and 'control period-no exercise' for 12 more weeks
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality during hemodialysis<br>During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis. | Other: Virtual reality exercise during hemodialysis<br>* Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment<br>|
| No Intervention: Control period - no exercise<br>During 12 weeks subjects will not exercise during hemodialysis | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline gait speed at 12 weeks | Speed to cover 4 meters at normal speed | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline sit to stand 10 at 12 weeks | Time to perform 10 sit to stand repetitions, | Baseline, 12 weeks | 
| Change from baseline sit to stand 60 at 12 weeks | Sit to stand repetitions performed in 60 seconds | Baseline, 12 weeks | 
| Change from baseline timed up and go at 12 weeks | Time to stand up, walk 3 meters, come back and sit down again | Baseline, 12 weeks | 
| Change from baseline short physical performance battery at 12 weeks | Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed | Baseline, 12 weeks | 
| Change from baseline handgrip at 12 weeks | Bilateral handgrip strength | Baseline, 12 weeks | 
| Change from baseline one-leg standing test at 12 weeks | Time achieved while standing on one leg | Baseline, 12 weeks | 
| Change from baseline one-leg heel rise test at 12 weeks | Number of heel rise repetitions achieved | Baseline, 12 weeks | 
| Change from baseline 6 minutes walk test at 12 weeks | Number of meters walked in 6 minutes | Baseline, 12 weeks | 
| Change from baseline Physical activity level at 12 weeks | Physical activity questionnaires | Baseline, 12 weeks | 
| Change from baseline Health related quality of life at 12 weeks | Short Form 36 questionnaire to measure health-related quality of life | Baseline, 12 weeks | 
| Change from baseline Cognitive function at 12 weeks | Mini-mental State Examination questionnaire | Baseline, 12 weeks | 
| Adherence | Sessions performed/sessions offered | 12 weeks | 
| Healthcare resources expenditure and costs | Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation. | 12 months before starting the exercise program- 12 months after the starting date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, physical function, health related quality of life