Virtual Reality Intradialysis: Last vs. First Part of the Session
- Conditions
- End Stage Renal Disease on DialysisHemodialysis Complication
- Interventions
- Other: Conventional exerciseOther: Exercise during the last two hours of the hemodialysis session
- Registration Number
- NCT04046042
- Lead Sponsor
- Cardenal Herrera University
- Brief Summary
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
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'.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional exercise time Conventional exercise During 12 months subjects will exercise during the first two hours of the hemodialysis session. A virtual reality exercise program will be implemented Experimental group Exercise during the last two hours of the hemodialysis session During 12 months subjects will exercise during the last two hours of the hemodialysis session. A virtual reality exercise program will be implemented
- Primary Outcome Measures
Name Time Method Number of hypotension episodes 12 Months Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
- Secondary Outcome Measures
Name Time Method Adherence, as number of sessions performed /number of sessions offered Baseline, 3 Months, 6 months and 12 months Sessions performed/sessions offered
Change from baseline handgrip at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Bilateral handgrip strength
Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months Baseline and 3 months Postdialysis rebound urea, creatinine, phosphorus and potassium. All measurements presented as a percentage.
Change from baseline short physical performance battery at 3 months, 6 months, and 12 months Baseline, 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
Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Number of heel rise repetitions achieved
Change from baseline dialysis dose at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Dialysis dose, measured through Kt/V
Change from baseline gait speed at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Speed to cover 4 meters, in meters/second
Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Muscle strength measured with a handheld dynamometer on the main muscle groups during hemodialysis
Change from baseline one-leg standing test at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Time achieved while standing on one leg
Change from baseline timed up and go at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Time to stand up, walk 3 meters, come back and sit down again
Change from baseline Cognitive function at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Mini-mental State Examination questionnaire, score ranges from 0 to 30, higher scores indicates higher cognitive function
Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months Baseline, 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
Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Time to perform 10 repetitions sit to stand
Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Sit to stand repetitions performed in 60 seconds
Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Number of meters walked in 6 minutes
Change from baseline Physical activity level at 3 months, 6 months, and 12 months Baseline, 3 Months, 6 months and 12 months Physical activity questionnaires
Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months Baseline, 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.
Change from baseline Health related quality of life at 3 months, 6 months, and 12 months Baseline, 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
Trial Locations
- Locations (1)
Hospital de Manises
🇪🇸Manises, Valencia, Spain