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

December 29, 2025 updated by: Ezgi Ceren Ozcan, Dokuz Eylul University

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

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 PH 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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Balcova
      • Izmir, Balcova, Turkey (Türkiye), 35140
        • Dokuz Eylul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Video Games Intervention

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.

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise load end heart rate
Time Frame: Change from baseline to end of 20 minutes of exercise loading
It will be measured with a pulse oximeter at the end of 20 minutes of exercise loading.
Change from baseline to end of 20 minutes of exercise loading
Exercise load end blood pressure
Time Frame: Change from baseline to end of 20 minutes of exercise loading
It will be measured with a sphygmomanometer at the end of 20 minutes of exercise loading.
Change from baseline to end of 20 minutes of exercise loading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise load end perceived effort
Time Frame: Change from baseline to end of 20 minutes of exercise loading
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.
Change from baseline to end of 20 minutes of exercise loading
Exercise load end oxygen saturation
Time Frame: Change from baseline to end of 20 minutes of exercise loading
Oxygen saturation will be evaluated by pulse oximetry at the end of 20 minutes of exercise loading.
Change from baseline to end of 20 minutes of exercise loading
Exercise load end shortness of breath
Time Frame: Change from baseline to end of 20 minutes of exercise loading
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.
Change from baseline to end of 20 minutes of exercise loading
Evaluation of energy expenditure
Time Frame: During exercise intervention, average 20 minutes
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.
During exercise intervention, average 20 minutes
Evaluation of Arterial stiffness
Time Frame: Change from baseline to end of 20 minutes of exercise loading
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.
Change from baseline to end of 20 minutes of exercise loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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