Renal Insufficiency, ChronicNCT06038383
Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During Hemodialysis
A study testing Group A - Intervention with Virtual Reality (VR), Group B - Intervention with Stationary Bike (SB) and Group A - Intervention with Stationary Bike (SB) - Crossover in people with Renal Insufficiency, Chronic, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Group A - Intervention with Virtual Reality (VR), Group B - Intervention with Stationary Bike (SB) and Group A - Intervention with Stationary Bike (SB) - Crossover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Comitê de Etica da Universidade Federal de São Paulo
São Paulo, 04.023-900
About this study
Official title: Effect of Physical Exercise Performed Through Virtual Reality Games on the Modulation of Heart Rate Variability in Chronic Renal Patients During Hemodialysis.
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.
Read more
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.
Read the detailed description
The objective of this Longitudinal CrossOver Clinical Trial is to compare changes in heart rate variability modulation in chronic renal patients undergoing conventional physical exercise and in a virtual environment during hemodialysis sessions.
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
- Renal Insufficiency, Chronic
- Being tested
- Group A - Intervention with Virtual Reality (VR), Group B - Intervention with Stationary Bike (SB), Group A - Intervention with Stationary Bike (SB) - Crossover, Group B - Intervention with Virtual Reality (VR) - Crossover
- Keywords
- hemodialysis, physical exercise, virtual reality, Renal Insufficiency, heart rate variability
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A - Intervention with Virtual Reality (VR)Device
Group of people with kidney disease that performed VR intervention during hemodialysis.
Group B - Intervention with Stationary Bike (SB)Device
Group of people with kidney disease that performed SB intervention during hemodialysis.
Group A - Intervention with Stationary Bike (SB) - CrossoverDevice
Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
Group B - Intervention with Virtual Reality (VR) - CrossoverDevice
Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Intervention with Virtual Reality (VR) | Experimental | Group of people with kidney disease that enrolled the intervention with VR during hemodialysis. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Group B - Intervention with Virtual Reality (VR) - Crossover |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (4)
Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by blood pressure in mmHg
Measured: 20 days
Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by heart rate in beats per minute.
Measured: 20 days
Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by respiratory rate in incursions per minute.
Measured: 20 days
Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by oxygen saturation in percentage.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Talita Dias da Silva-Magalhães, University of Sao Paulo
- Investigators
- Talita D Silva, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038383
- Sponsor's protocol ID
- 5.802.024
- Status last verified
- Jun 2025
- First submitted
- 29 Aug 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Exercise Performed Through Virtual Reality Games on the Modulation of Heart Rate Variability in Chronic Renal Patients During Hemodialysis.
- ClinicalTrials.gov ID
- NCT06038383
- Acronym / sponsor ID
- 5.802.024
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- hemodialysis, physical exercise, virtual reality, Renal Insufficiency, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this Longitudinal CrossOver Clinical Trial is to compare changes in heart rate variability modulation in chronic renal patients undergoing conventional physical exercise and in a virtual environment during hemodialysis sessions.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - Intervention with Virtual Reality (VR) | Experimental | Device: Group A - Intervention with Virtual Reality (VR)Group of people with kidney disease that enrolled the intervention with VR during hemodialysis. |
| Group B - Intervention with Stationary Bike (SB) | Active comparator | Device: Group B - Intervention with Stationary Bike (SB)Group of people with kidney disease that enrolled the intervention with SB during hemodialysis. |
| Group A - Intervention with Stationary Bike (SB) - Crossover | Experimental | Device: Group A - Intervention with Stationary Bike (SB) - CrossoverGroup of people with kidney disease that enrolled the intervention with SB during hemodialysis, after the period of washout. |
| Group B - Intervention with Virtual Reality (VR) - Crossover | Active comparator | Device: Group B - Intervention with Virtual Reality (VR) - CrossoverGroup of people with kidney disease that enrolled the intervention with VR during hemodialysis, after the period of washout. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A - Intervention with Virtual Reality (VR)Group of people with kidney disease that performed VR intervention during hemodialysis. | Device | Group A - Intervention with Virtual Reality (VR) |
| Group B - Intervention with Stationary Bike (SB)Group of people with kidney disease that performed SB intervention during hemodialysis. | Device | Group B - Intervention with Stationary Bike (SB) |
| Group A - Intervention with Stationary Bike (SB) - CrossoverGroup of people with kidney disease that performed SB intervention during hemodialysis after the washout period. | Device | Group A - Intervention with Stationary Bike (SB) - Crossover |
| Group B - Intervention with Virtual Reality (VR) - CrossoverGroup of people with kidney disease that performed VR intervention during hemodialysis after the washout period. | Device | Group B - Intervention with Virtual Reality (VR) - Crossover |
Primary outcome
Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis.
Time frame: 4 days
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 secondary outcomes
Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Time frame: 20 days
Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Time frame: 20 days
Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Time frame: 20 days
Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talita D Silva, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A - Intervention with Virtual Reality (VR), Group B - Intervention with Stationary Bike (SB) and Group A - Intervention with Stationary Bike (SB) - Crossover in people with Renal Insufficiency, Chronic, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis. (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.