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

Primary Purpose

Renal Insufficiency, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
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
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring hemodialysis, physical exercise, virtual reality, Renal Insufficiency, heart rate variability

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Comitê de Etica da Universidade Federal de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by blood pressure in mmHg
Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by heart rate in beats per minute.
Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by respiratory rate in incursions per minute.
Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Measurements made by oxygen saturation in percentage.

Full Information

First Posted
August 29, 2023
Last Updated
September 12, 2023
Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT06038383
Brief Title
Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During Hemodialysis
Official Title
Effect of Physical Exercise Performed Through Virtual Reality Games on the Modulation of Heart Rate Variability in Chronic Renal Patients During Hemodialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
hemodialysis, physical exercise, virtual reality, Renal Insufficiency, heart rate variability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - Intervention with Virtual Reality (VR)
Arm Type
Experimental
Arm Description
Group of people with kidney disease that enrolled the intervention with VR during hemodialysis.
Arm Title
Group B - Intervention with Stationary Bike (SB)
Arm Type
Active Comparator
Arm Description
Group of people with kidney disease that enrolled the intervention with SB during hemodialysis.
Arm Title
Group A - Intervention with Stationary Bike (SB) - Crossover
Arm Type
Experimental
Arm Description
Group of people with kidney disease that enrolled the intervention with SB during hemodialysis, after the period of washout.
Arm Title
Group B - Intervention with Virtual Reality (VR) - Crossover
Arm Type
Active Comparator
Arm Description
Group of people with kidney disease that enrolled the intervention with VR during hemodialysis, after the period of washout.
Intervention Type
Device
Intervention Name(s)
Group A - Intervention with Virtual Reality (VR)
Intervention Description
Group of people with kidney disease that performed VR intervention during hemodialysis.
Intervention Type
Device
Intervention Name(s)
Group B - Intervention with Stationary Bike (SB)
Intervention Description
Group of people with kidney disease that performed SB intervention during hemodialysis.
Intervention Type
Device
Intervention Name(s)
Group A - Intervention with Stationary Bike (SB) - Crossover
Intervention Description
Group of people with kidney disease that performed SB intervention during hemodialysis after the washout period.
Intervention Type
Device
Intervention Name(s)
Group B - Intervention with Virtual Reality (VR) - Crossover
Intervention Description
Group of people with kidney disease that performed VR intervention during hemodialysis after the washout period.
Primary Outcome Measure Information:
Title
Heart Rate Variability behavior during interventions with Virtual Reality and Stationary Bike while in hemodialysis.
Description
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
4 days
Secondary Outcome Measure Information:
Title
Blood pressure during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Description
Measurements made by blood pressure in mmHg
Time Frame
20 days
Title
Heart rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Description
Measurements made by heart rate in beats per minute.
Time Frame
20 days
Title
Respiratory rate during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Description
Measurements made by respiratory rate in incursions per minute.
Time Frame
20 days
Title
Oxygen saturation during interventions with Virtual Reality and Stationary Bike while in hemodialysis
Description
Measurements made by oxygen saturation in percentage.
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline C Macedo-Dias, Masters
Phone
+5515991929494
Email
jacqueline.macedo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Talita D Silva, PhD
Phone
+5511998590188
Email
ft.talitadias@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talita D Silva, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comitê de Etica da Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04.023-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Jorge
Phone
+55(11)55711062
Email
cep@unifesp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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

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