Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During Hemodialysis
NCT ID: NCT06038383
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2023-09-01
2024-12-01
Brief Summary
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Objective: To assess changes in heart rate variability modulation and the quality of life of chronic kidney disease patients undergoing virtual reality-based exercise during hemodialysis sessions.
Methods: A longitudinal, controlled, randomized crossover clinical trial. The chronic kidney disease groups will be divided into two groups, Group A (GA) and Group B (GB). Group GA will engage in 10 interventions, with each intervention involving the completion of 3 sessions of a Virtual Reality (VR) game lasting 5 minutes each, totaling 15 minutes of exercise. Group GB will participate in 10 interventions, with each intervention comprising 15 minutes of physical exercise on a cycle ergometer, referred to here as conventional exercise.
After the initial 10 interventions, the groups will switch exercises; that is, GA will cease VR interventions and begin another 10 interventions with conventional exercise, while GB will stop conventional exercise interventions and start another 10 interventions with VR.
The Kidney Disease Quality of Life Short Form questionnaire, Beck's Anxiety and Depression Inventory, and the International Physical Activity Questionnaire will also be administered to all groups.
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Detailed Description
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The main questions it aims to answer are:
What are the differences in changes in heart rate variability modulation between chronic renal patients who undergo conventional physical exercise before and during hemodialysis sessions, and those who engage in virtual environment exercises?
How does the virtual environment influence changes in heart rate variability modulation compared to conventional physical exercise in chronic renal patients before and during hemodialysis sessions?
What is the relative effectiveness of conventional physical exercise compared to virtual environment exercise in improving heart rate variability modulation in chronic renal patients before and during hemodialysis sessions?
Group A will participate in 10 interventions, each intervention consisting of playing 3 rounds of a Virtual Reality game lasting 5 minutes, totaling 15 minutes of exercise. Group B will participate in 10 interventions, each intervention consisting of 15 minutes of physical exercise on a cycle ergometer, referred to here as conventional exercise.
After the initial 10 interventions,there will be a 1-week washout period and the groups will switch exercises. Heart rate and respiratory rate, oxygen saturation, systemic blood pressure, laboratory tests, as well as the Kidney Disease Quality of Life Short Form questionnaire, the Beck Anxiety and Depression Inventory, and the International Physical Activity Questionnaire will be assessed in all groups.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A - Intervention with Virtual Reality (VR)
Group of people with kidney disease that enrolled the intervention with VR during hemodialysis.
Group A - Intervention with Virtual Reality (VR)
Group of people with kidney disease that performed VR intervention during hemodialysis.
Group B - Intervention with Stationary Bike (SB)
Group of people with kidney disease that enrolled the intervention with SB during hemodialysis.
Group B - Intervention with Stationary Bike (SB)
Group of people with kidney disease that performed SB intervention during hemodialysis.
Group A - Intervention with Stationary Bike (SB) - Crossover
Group of people with kidney disease that enrolled the intervention with SB during hemodialysis, after the period of washout.
Group A - Intervention with Stationary Bike (SB) - Crossover
Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
Group B - Intervention with Virtual Reality (VR) - Crossover
Group of people with kidney disease that enrolled the intervention with VR during hemodialysis, after the period of washout.
Group B - Intervention with Virtual Reality (VR) - Crossover
Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
Interventions
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Group A - Intervention with Virtual Reality (VR)
Group of people with kidney disease that performed VR intervention during hemodialysis.
Group B - Intervention with Stationary Bike (SB)
Group of people with kidney disease that performed SB intervention during hemodialysis.
Group A - Intervention with Stationary Bike (SB) - Crossover
Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
Group B - Intervention with Virtual Reality (VR) - Crossover
Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years.
* Possession of medical clearance for participating in physical exercise.
* Ability for lower limb movement without affecting dialysis treatment.
Exclusion Criteria
* Reports of persistent pain and fatigue arising after the start of exercise training.
* Changes in the type of renal treatment during the protocol application period.
* Absence from three consecutive exercise training sessions.
18 Years
70 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
University of Sao Paulo
OTHER
Responsible Party
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Talita Dias da Silva-Magalhães
Researcher
Principal Investigators
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Talita D Silva, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
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Comitê de Etica da Universidade Federal de São Paulo
São Paulo, , Brazil
Countries
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Other Identifiers
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5.802.024
Identifier Type: -
Identifier Source: org_study_id
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