Comitê de Etica da Universidade Federal de São Paulo
São Paulo, 04.023-900, Brazil
NCT Number: NCT06038383
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
São Paulo, 04.023-900, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group of people with kidney disease that performed VR intervention during hemodialysis.
Group of people with kidney disease that performed SB intervention during hemodialysis.
Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
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.
Time frame: 20 days
Measurements made by blood pressure in mmHg
Time frame: 20 days
Measurements made by heart rate in beats per minute.
Time frame: 20 days
Measurements made by respiratory rate in incursions per minute.
Time frame: 20 days
Measurements made by oxygen saturation in percentage.
University of Sao Paulo
Other
Effect of Physical Exercise Performed Through Virtual Reality Games on the Modulation of Heart Rate Variability in Chronic Renal Patients During Hemodialysis.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04876963
Arrhythmias, Cardiac, Cardiovascular Diseases
Copenhagen, Denmark
View Trial DetailsNCT02458248
Chronic Disease, Disease Attributes
Galway, Ireland
View Trial DetailsNCT03836508
Chronic Disease, Dialysis Related Complication
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03095391
Acute Kidney Injury, Chronic Disease
Birmingham, Alabama, United States
View Trial Details