Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During Hemodialysis

NCT06038383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-27

No results posted yet for this study

Summary

Patients with chronic kidney diseases, especially those requiring hemodialysis, are characterized by an increased risk of numerous morbidities. This is a condition that significantly impacts the patient's quality of life, leads to dependence, and involves high-cost treatment. The physical condition of chronic kidney disease patients falls well below the recommendations set by the World Health Organization, indicating effective difficulties in the approaches used for implementing physical activity programs. New approaches must be considered. Physical activity through virtual reality can foster greater social integration of patients with physical exercise during hemodialysis, enabling improved quality of life and decreased frailty levels for these individuals due to its playful and motivational nature.

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.

Conditions

  • Renal Insufficiency, Chronic

Interventions

DEVICE

Group A - Intervention with Virtual Reality (VR)

Group of people with kidney disease that performed VR intervention during hemodialysis.

DEVICE

Group B - Intervention with Stationary Bike (SB)

Group of people with kidney disease that performed SB intervention during hemodialysis.

DEVICE

Group A - Intervention with Stationary Bike (SB) - Crossover

Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.

DEVICE

Group B - Intervention with Virtual Reality (VR) - Crossover

Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER
  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Talita D Silva, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-11-01
Completion
2024-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06038383 on ClinicalTrials.gov