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.
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'.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Virtual reality exercise performed during the first two hours of the hemodialysis session
Virtual reality exercise performed during the last two hours of the hemodialysis session
Hospital de Manises
Manises, Valencia, Spain
RECRUITINGNumber of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Time frame: 3 Months
Number of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Time frame: 6 Months
Number of hypotension episodes
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
Time frame: 12 Months
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.
Time frame: Baseline and 3 months
Change from baseline dialysis dose at 3 months, 6 months, and 12 months
Dialysis dose, measured through Kt/V
Time frame: Baseline, 3 Months, 6 months and 12 months
Adherence, as number of sessions performed /number of sessions offered
Sessions performed/sessions offered
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 Months, 6 months and 12 months
Change from baseline handgrip at 3 months, 6 months, and 12 months
Bilateral handgrip strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, 3 Months, 6 months and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.