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Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Active Video Games Intervention
Traditional Exercise Intervention
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, active video games

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have been diagnosed with PH Volunteering Being clinically stable New York Heart Association 1-3 class Have not received physiotherapy in the last 6 months Exclusion Criteria: Presence of unstable angina Presence of severe neurological, pulmonary and musculoskeletal disease The patient's desire to quit the study Playing more than 20 minutes of active video games 3 days a week Pregnancy Having significant and uncompensated visual and auditory deficiencies

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active Video Games Intervention

Traditional Exercise Intervention

Arm Description

Active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and sensor. Active video games consist of Rally Ball, Rive Rush and Reflex Ridge games.

Traditional Exercise Intervention consist of active exercises for the upper extremities, active exercises for the lower extremities, active exercises for the body.

Outcomes

Primary Outcome Measures

Exercise load end heart rate
It will be measured with a pulse oximeter at the end of 20 minutes of exercise loading.
Exercise load end blood pressure
It will be measured with a sphygmomanometer at the end of 20 minutes of exercise loading.

Secondary Outcome Measures

Exercise load end perceived effort
The degree of perceived effort will be evaluated with the Modified Borg Scale (M.Borg 0-10) at the end of 20 minutes of exercise loading. As the modified borg score of the person increases, the perceived effort will increase.
Exercise load end oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry at the end of 20 minutes of exercise loading.
Exercise load end shortness of breath
Shortness of breath will be assessed with the Modified Borg Scale(M.Borg 0-10) at the end of 20 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived shortness of breath will increase.
Evaluation of energy expenditure
Energy expenditure during active video games and traditional exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.
Evaluation of Arterial stiffness
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.

Full Information

First Posted
May 3, 2023
Last Updated
July 2, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05901168
Brief Title
Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension
Official Title
Comparison of Acute Responses of Active Video Games and Traditional Exercise Program in Patients With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

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
At least 20 volunteers with a diagnosis of Pulmonary Hypertension in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. The aim of this study is to examine the acute effects of active video games compared to traditional exercise and the effects on energy expenditure and enjoyment in PD patients. Demographic and clinical information of the participants will be questioned. Active video games and home-based exercise sessions will be held randomly/by the same person with a break of at least 1 day in 1 week, lasting 20 minutes. Heart rate, blood pressure, shortness of breath and oxygen saturation will be measured before and after the sessions. In addition, energy expenditure, heart rate, perceived exertion, shortness of breath and oxygen saturation will be recorded during the sessions. In addition, arterial stiffness will be evaluated with a non-invasive device. At the end of the sessions, whether people like active video games or not will be questioned with a 10-point Likert-type scale.
Detailed Description
Pulmonary hypertension (PH) is a progressive disease that can lead to death as a result of right ventricular overload and right heart failure. Early diagnosis and treatment are important. In cardiac catheterization, it is defined as the measurement of mean pulmonary artery pressure above 20 mmHg. Exercise training in Pulmonary Disease has benefits such as improving endothelial dysfunction, muscle blood supply, peripheral O2 extraction, muscle strength, ventilation efficiency, ventricular contractility, reducing adrenergic tone, increasing vagal modulation, and restoring baroreflex arterial sensitivity. There are studies and meta-analyses that show that exercise programs applied under supervision in addition to optimal medical treatment and tailored to the patient have positive effects on functional capacity and quality of life in all Pulmonary Disease groups. Active video games are reported as a useful method to increase adherence to physical exercise routines. Active video games are defined as: playing video games that require intense physical exercise, for exercise purposes, and in which the participant moves large muscle groups in response to cues. It has been reported that active video games that require physical exertion can improve physical activity. Body movements performed in active video games result in varying levels of intensity and energy expenditure. Studies investigating energy expenditure in various age groups have shown that active video games promote physical activity and increase energy expenditure at levels appropriate for moderate to vigorous physical activity. However, the effect of active video games on energy expenditure, attainment of moderate intensity, and acute responses in individuals with Pulmonary Disease compared to conventional exercise has not been clearly investigated. The aim of this study is to examine the acute effects of active video games compared to traditional exercise and the effects on energy expenditure and enjoyment in Pulmonary Disease patients. Each patient will complete the exercise training and active video game intervention in random order and different days. Active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and sensor. Active video games; will consist of River Rush, Rally Ball and Reflex Ridge games. Traditional-Based Exercise Intervention will consist of active exercises for the upper extremity (without support), active exercises for the lower extremities and body exercises.upper extremity exercises are shoulder flexion, shoulder abduction, elbow flexion at shoulder 90° flexion. Lower extremity exercises are: ankle-foot movements (ankle pumping exercise) heel raise, knee extension in sitting high, hip-knee flexion while lying supine. Body exercises are: bridging andtrunk rotations in sitting. Before and after the sessions; acute responses, vascular responses and enjoyment will be measured. In addition, energy expenditure will be recorded during the sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, active video games

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active Video Games Intervention
Arm Type
Active Comparator
Arm Description
Active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and sensor. Active video games consist of Rally Ball, Rive Rush and Reflex Ridge games.
Arm Title
Traditional Exercise Intervention
Arm Type
Active Comparator
Arm Description
Traditional Exercise Intervention consist of active exercises for the upper extremities, active exercises for the lower extremities, active exercises for the body.
Intervention Type
Other
Intervention Name(s)
Active Video Games Intervention
Intervention Description
Participants will complete active video games in the same order until they fill 20 minutes after the first 5 minutes of warm-up. In addition, during the change between games (lasting approximately 20 seconds), patients will be instructed by a therapist to perform combined exercises to minimize immobility time. These exercises are: elbow flexion and foot flexion, shoulder flexion and unilateral hip extension, and arm abduction and squat exercises that will prevent the patient from cooling down.
Intervention Type
Other
Intervention Name(s)
Traditional Exercise Intervention
Intervention Description
Active exercises for the upper extremities (without support): Shoulder flexion, Shoulder abduction, Elbow flexion at shoulder 90° flexion. Active exercises for the lower extremities: Ankle-foot movements (ankle pumping exercise), heel raise, Knee extension in sitting high, Hip-knee flexion while lying supine Body: Bridging, Trunk rotations in sitting These exercises will be done in 1 set of 8-10 repetitions. It will take about 20 minutes.
Primary Outcome Measure Information:
Title
Exercise load end heart rate
Description
It will be measured with a pulse oximeter at the end of 20 minutes of exercise loading.
Time Frame
Change from baseline to end of 20 minutes of exercise loading
Title
Exercise load end blood pressure
Description
It will be measured with a sphygmomanometer at the end of 20 minutes of exercise loading.
Time Frame
Change from baseline to end of 20 minutes of exercise loading
Secondary Outcome Measure Information:
Title
Exercise load end perceived effort
Description
The degree of perceived effort will be evaluated with the Modified Borg Scale (M.Borg 0-10) at the end of 20 minutes of exercise loading. As the modified borg score of the person increases, the perceived effort will increase.
Time Frame
Change from baseline to end of 20 minutes of exercise loading
Title
Exercise load end oxygen saturation
Description
Oxygen saturation will be evaluated by pulse oximetry at the end of 20 minutes of exercise loading.
Time Frame
Change from baseline to end of 20 minutes of exercise loading
Title
Exercise load end shortness of breath
Description
Shortness of breath will be assessed with the Modified Borg Scale(M.Borg 0-10) at the end of 20 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived shortness of breath will increase.
Time Frame
Change from baseline to end of 20 minutes of exercise loading
Title
Evaluation of energy expenditure
Description
Energy expenditure during active video games and traditional exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.
Time Frame
During exercise intervention, average 20 minutes
Title
Evaluation of Arterial stiffness
Description
Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.
Time Frame
Change from baseline to end of 20 minutes of exercise loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with PH Volunteering Being clinically stable New York Heart Association 1-3 class Have not received physiotherapy in the last 6 months Exclusion Criteria: Presence of unstable angina Presence of severe neurological, pulmonary and musculoskeletal disease The patient's desire to quit the study Playing more than 20 minutes of active video games 3 days a week Pregnancy Having significant and uncompensated visual and auditory deficiencies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi Ceren OZCAN
Phone
+905532704351
Email
ezgicerenozcan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Buse OZCAN KAHRAMAN, Study Director
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
State/Province
Balcova
ZIP/Postal Code
35140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension

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