Virtual Reality During Hemodialysis
- Conditions
- Hemodialysis-Induced SymptomEnd Stage Renal Disease
- Interventions
- Other: Virtual reality exercise during hemodialysis
- Registration Number
- NCT03456414
- Lead Sponsor
- Cardenal Herrera University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- At least 3 months in hemodialysis treatment
- Clinically stable
- Recent cardiac events (less than 3 months)
- Unable to exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Virtual reality during hemodialysis Virtual reality exercise during hemodialysis During 12 weeks subjects will exercise during hemodialysis. The intervention will be virtual reality exercise during hemodialysis.
- Primary Outcome Measures
Name Time Method Change from baseline gait speed at 12 weeks Baseline, 12 weeks Speed to cover 4 meters at normal speed
- Secondary Outcome Measures
Name Time Method Change from baseline short physical performance battery at 12 weeks Baseline, 12 weeks Score achieved at the battery that includes balance tests, sit to stand to sit 5 and and gait speed
Adherence 12 weeks Sessions performed/sessions offered
Change from baseline sit to stand 10 at 12 weeks Baseline, 12 weeks Time to perform 10 sit to stand repetitions,
Change from baseline timed up and go at 12 weeks Baseline, 12 weeks Time to stand up, walk 3 meters, come back and sit down again
Change from baseline one-leg standing test at 12 weeks Baseline, 12 weeks Time achieved while standing on one leg
Change from baseline one-leg heel rise test at 12 weeks Baseline, 12 weeks Number of heel rise repetitions achieved
Healthcare resources expenditure and costs 12 months before starting the exercise program- 12 months after the starting date Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation.
Change from baseline sit to stand 60 at 12 weeks Baseline, 12 weeks Sit to stand repetitions performed in 60 seconds
Change from baseline handgrip at 12 weeks Baseline, 12 weeks Bilateral handgrip strength
Change from baseline 6 minutes walk test at 12 weeks Baseline, 12 weeks Number of meters walked in 6 minutes
Change from baseline Physical activity level at 12 weeks Baseline, 12 weeks Physical activity questionnaires
Change from baseline Cognitive function at 12 weeks Baseline, 12 weeks Mini-mental State Examination questionnaire
Change from baseline Health related quality of life at 12 weeks Baseline, 12 weeks Short Form 36 questionnaire to measure health-related quality of life
Trial Locations
- Locations (1)
Hospital de Manises
🇪🇸Manises, Valencia, Spain