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

NCT06038383 | Completed

• 1 other identifier: 5.802.024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hemodialysis; physical exercise; virtual reality; Renal Insufficiency; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis.

  Measurements made by heart rate variability indices, using both linear and non-linear measurements, using a chest trap that captures the R-R intervals in milliseconds.

  4 days

Secondary Outcomes (4)

• Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis

  20 days

• Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis

  20 days

• Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis

  20 days

• Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis

  20 days

Study Arms (4)

Group A - Intervention with Virtual Reality (VR)

EXPERIMENTAL

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

Device: Group A - Intervention with Virtual Reality (VR)

Group B - Intervention with Stationary Bike (SB)

ACTIVE COMPARATOR

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

Device: Group B - Intervention with Stationary Bike (SB)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

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

Interventions

Group A - Intervention with Virtual Reality (VR) DEVICE

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

Group A - Intervention with Virtual Reality (VR)

Group B - Intervention with Stationary Bike (SB) DEVICE

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

Group B - Intervention with Stationary Bike (SB)

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed chronic renal insufficiency requiring hemodialysis at any classification level.
• Age over 18 years.
• Possession of medical clearance for participating in physical exercise.
• Ability for lower limb movement without affecting dialysis treatment.

You may not qualify if:

• Acute use of medications that affect the cardiovascular system and/or alter the function of the nervous system, unless they are part of the disease treatment protocol and are part of the patient's routine.
• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Comitê de Etica da Universidade Federal de São Paulo

São Paulo, 04.023-900, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Renal Insufficiency

Interventions

Cross-Over Studies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Talita D Silva, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)