Pulmonary HypertensionNCT05901168
Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension
A study testing Active Video Games Intervention and Traditional Exercise Intervention in people with Pulmonary Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Active Video Games Intervention and Traditional Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Active Video Games Intervention, Traditional Exercise Intervention
- Keywords
- pulmonary hypertension, active video games
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Video Games InterventionOther
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.
Traditional Exercise InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Video Games Intervention | Active comparator | 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. Receives: Other: Active Video Games Intervention |
| Traditional Exercise Intervention | Active comparator | Traditional Exercise Intervention consist of active exercises for the upper extremities, active exercises for the lower extremities, active exercises for the body. Receives: Other: Traditional Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise load end heart rate
It will be measured with a pulse oximeter at the end of 20 minutes of exercise loading.
Measured: Change from baseline to 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.
Measured: Change from baseline to end of 20 minutes of exercise loading
Secondary outcomes (5)
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.
Measured: Change from baseline to end of 20 minutes of exercise loading
Exercise load end oxygen saturation
Oxygen saturation will be evaluated by pulse oximetry at the end of 20 minutes of exercise loading.
Measured: Change from baseline to 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.
Measured: Change from baseline to end of 20 minutes of exercise loading
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.
Measured: During exercise intervention, average 20 minutes
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.
Measured: Change from baseline to end of 20 minutes of exercise loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start1 Aug 2023
- Primary completion1 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Ceren Ozcan, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901168
- Sponsor's protocol ID
- DokuzEU-PAH-001
- Status last verified
- Dec 2025
- First submitted
- 3 May 2023
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Responses of Active Video Games and Traditional Exercise Program in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05901168
- Acronym / sponsor ID
- DokuzEU-PAH-001
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, active video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 13 Jun 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Video Games Intervention | Active comparator | Other: Active Video Games InterventionActive 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 | Active comparator | Other: Traditional Exercise InterventionTraditional Exercise Intervention consist of active exercises for the upper extremities, active exercises for the lower extremities, active exercises for the body. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Active Video Games InterventionParticipants 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. | Other | Active Video Games Intervention |
| Traditional Exercise InterventionActive 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. | Other | Traditional Exercise Intervention |
Primary outcome
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.
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.
5 secondary outcomes
Exercise load end perceived effort
Time frame: 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
Exercise load end shortness of breath
Time frame: Change from baseline to end of 20 minutes of exercise loading
Evaluation of energy expenditure
Time frame: During exercise intervention, average 20 minutes
Evaluation of Arterial stiffness
Time frame: Change from baseline to end of 20 minutes of exercise loading
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 2 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Video Games Intervention and Traditional Exercise Intervention in people with Pulmonary Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 2 Jan 2026. 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 Turkey (Türkiye). 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?
Exercise load end heart rate (time frame: Change from baseline to end of 20 minutes of exercise loading). The study lists 2 primary outcomes in all. 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 2 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.