Idiopathic Pulmonary Arterial HypertensionNCT07558460
Virtual Reality in Patients With Pulmonary Hypertension: A Randomized Controlled Trial
A study testing Virtual Reality Group in people with Idiopathic Pulmonary Arterial Hypertension, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this research is to investigate the effectiveness of exercise administered via immersive virtual reality in patients with pulmonary hypertension, thereby contributing to the existing literature on this subject. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension
- What is being tested?
- Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Idiopathic Pulmonary Arterial Hypertension,
- Stable pharmacological treatment for the past 3 months,
- Hemodynamic and clinical stability for at least the past three months,
- Age of 18-65,
- Voluntary participation in the study and signing the informed consent form,
- Being classified in the World Health Organization-Functional Classification I, II or III.
Who cannot join
- The presence of an orthopedic or neurological problem that will affect functional tests and muscle strength measurement,
- Acute decompensated heart failure,
- Unstable angina pectoris,
- Uncontrolled hypertension,
- The presence of problems that hinder communication,
- Dizziness, vertigo,
- Severe visual impairment,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa/ Cardiology Institute
Istanbul, Fatih, 34180
About this study
Official title: Effectiveness of Exercise Training Applied Through Virtual Reality in Patients With Pulmonary Hypertension
The goal of this research is to investigate the effectiveness of exercise administered via immersive virtual reality in patients with pulmonary hypertension, thereby contributing to the existing literature on this subject. The main question is whether exercises delivered via immersive virtual reality are effective to improve physical performance, functional capacity, dyspnea, muscle strength, fatigue, quality of life, depression and anxiety.
Read the detailed description
The number of studies examining the effects of exercise training in pulmonary hypertension (PH) is limited in the literature. Given the chronic nature of PH and the benefits of exercise in PH, the importance of exercise programs that include motivation as a factor becomes apparent. Therefore, the aim of this research is to investigate the effectiveness of exercise programs implemented via virtual reality under the supervision of a physiotherapist in PH patients. To investigators' knowledge, there are no studies in the literature examining the effectiveness of exercise training conducted via virtual reality in PH patients. Therefore, another aim of this research is to identify virtual reality (VR) applications that can be used to improve clinical outcomes in PH patients and to contribute to the literature on the effectiveness of using innovative technologies in rehabilitation programs.
- Being tested
- Virtual Reality Group
- Keywords
- idiopathic pulmonary arterial hypertension, immersive virtual reality, exercise
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Patients assigned to Group 2 are involved in supervised exercise sessions 3 times a week during 8 weeks. Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Patients assigned to Group 1 are involved in supervised exercise sessions 3 times a week during 8 weeks. Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality Receives: Other: Virtual Reality Group |
| Control Group | No intervention | Patients assigned to Group 2 will not included any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Lower and upper extremity strength: Measurement is performed by having the person being tested exert maximum effort against the device during the measurement, and the person conducting the test respond with maximum force in the opposite direction to prevent movement. The tests are repeated three times, and the average of the values is recorded in Newtons (N).
Measured: at the beginning of the study and at the end of 8 week,
Hand Grip Strength
The tests will be repeated three times, and the average of the values will be recorded in kilograms of force (kgF).
Measured: at the beginning of the study and at the end of 8 weeks
Functional capacity of lower extremity
Six Minute Walking Test: Participants will be asked to walk as fast as possible at their own pace for 6 minutes on a 30-meter course. The distance walked by the patient will be recorded in meters.
Measured: at the beginning of the study and at the end of 8 weeks
Functional capacity of upper extremity
Six Minute Pegboard and Ring Test: A wooden platform with bars will be used during the test. Two bars will be placed at shoulder level and the other two 20 cm above shoulder level. Ten rings, each weighing 14 grams, will be placed on the lower bars: ten on the right and ten on the left, for a total of 20 rings. Patients will be asked to place as many rings as possible from the lower bars to the upper bars and then back to the lower bars using both hands for 6 minutes. At the end of this time, the number of rings moved will be recorded as the the total score, and the resting time will be recorded in seconds.
Measured: at the beginning of the study and at the end of 8 weeks
Physical performance
Short Physical Performance Battery: The test consists of 3 tests: walking 4 meters, standing up from a chair, and standing balance test.
Each test is scored between 0-4. The scores obtained by the participants, ranging from 1-4, indicate the progressive performance required to complete the test according to the specified times.
Walking test: Participants will be asked to walk 4 meters in a pre-marked corridor, and the time will be recorded and scored. The use of walking aids will be permitted, and saturation monitoring will be performed.
Standing up from a chair test: Participants will be asked to stand up once from a seated position with their arms crossed over their chest. Patients who can do this will be asked to stand up and sit down five times as quickly as possible, and the time will be recorded.
Standing balance test: 3 positions will be used; feet side-by-side and together, tandem, and half-tandem.
Measured: at the beginning of the study and at the end of 8 weeks
Secondary outcomes (6)
Dyspnea assessment
Modified Medical Research Council Dyspnea Scale: This scale was developed to assess the level of dyspnea in patients. The scale evaluates how much difficulty patients experience in daily life activities due to dyspnea. Individuals indicate the degree of shortness of breath with a score between 0 and 4. Higher scores indicate a greater perception of dyspnea.
Measured: at the beginning of the study and at the end of the 8 weeks
Physical Activity Level Assessment
International Physical Activity Questionnaire - Short Form: This is a 7-question questionnaire developed to determine physical activity levels, covering the past week. The questionnaire examines activities under the headings of vigorous physical activity, moderate physical activity, and walking. All activities are recorded in terms of frequency (days/week) and duration (minutes/day). A score in MET-min/week is calculated for all categories using a defined metabolic equivalent (MET) per activity, and the sum of these scores gives the total IPAQ-SF score. Standard MET values are accepted as 3.3 for walking, 4.0 for moderate activity, and 8.0 for vigorous activity. Sitting is assessed with a separate question and is not included in the total IPAQ-SF score.
Measured: at the beginning of the study and at the end of 8 weeks
Fatigue Assessment
Fatigue Severity Scale: The scale consists of 9 questions, each rated between 1 (strongly disagree) and 7 (strongly agree). The total value is divided by 9 to obtain the final score. An increased score indicates greater fatigue severity. A score of <2.8 indicates no fatigue, while a score >6.1 indicates chronic fatigue.
Measured: at the beginning of the study and at the end of 8 weeks
Quality of life assessment
EmPHasis 10: Developed for assessing quality of life in patients diagnosed with pulmonary hypertension, the EmPHasis-10 includes inquiries about significant consequences of the disease, such as shortness of breath, fatigue, and lack of energy, which can also affect social life. The scale consists of 10 questions, each a Likert-type question scored between 0 and 5. The total score of the scale ranges from 0 to 50 points. A high score indicates a poor quality of life due to symptoms.
Measured: at the beginning of the study and at the end of 8 weeks
Depression and anxiety assessment
Hospital Anxiety and Depression Scale: The scale consists of 14 questions in total. The Likert-type scale includes 7 questions to assess anxiety levels and 7 questions to assess depression levels. Scores for both sub-assessments range from 0 to 21. Higher scores indicate a worse level. For both sub-assessments, scores of 0-7 indicate a normal level, 8-10 indicate borderline mood disorder, and ≥11 indicate a mood disorder.
Measured: at the beginning of the study and at the end of the 8 weeks
Virtual Reality Experience Assessment
Simulator Sickness Questionnaire: This is a scale that assesses the safety of experiences that alter the perception of reality, such as virtual reality, and the symptoms of motion sickness. It consists of 16 items grouped into 3 subscales (oculomotor symptoms, disorientation, nausea). Each item is rated on a four-point scale (0 = I feel nothing, 1 = somewhat, 2 = moderate, and 3 = very), and the total score is the sum of the scores of the three subscales.
Measured: at the beginning of the study and at the end of the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start31 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Besides the immersive reality group, there is a controlled group which will not be included any kind of intervention during the study in our study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Öztürk, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558460
- Sponsor's protocol ID
- 2025/574
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Training Applied Through Virtual Reality in Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07558460
- Acronym / sponsor ID
- 2025/574
- Keywords
- idiopathic pulmonary arterial hypertension, immersive virtual reality, exercise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Apr 2026 (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.
The goal of this research is to investigate the effectiveness of exercise administered via immersive virtual reality in patients with pulmonary hypertension, thereby contributing to the existing literature on this subject. The main question is whether exercises delivered via immersive virtual reality are effective to improve physical performance, functional capacity, dyspnea, muscle strength, fatigue, quality of life, depression and anxiety.
Detailed description
The number of studies examining the effects of exercise training in pulmonary hypertension (PH) is limited in the literature. Given the chronic nature of PH and the benefits of exercise in PH, the importance of exercise programs that include motivation as a factor becomes apparent. Therefore, the aim of this research is to investigate the effectiveness of exercise programs implemented via virtual reality under the supervision of a physiotherapist in PH patients. To investigators' knowledge, there are no studies in the literature examining the effectiveness of exercise training conducted via virtual reality in PH patients. Therefore, another aim of this research is to identify virtual reality (VR) applications that can be used to improve clinical outcomes in PH patients and to contribute to the literature on the effectiveness of using innovative technologies in rehabilitation programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Besides the immersive reality group, there is a controlled group which will not be included any kind of intervention during the study in our study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupPatients assigned to Group 1 are involved in supervised exercise sessions 3 times a week during 8 weeks. Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality |
| Control Group | No intervention | –Patients assigned to Group 2 will not included any intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Idiopathic Pulmonary Arterial Hypertension,
- Stable pharmacological treatment for the past 3 months,
- Hemodynamic and clinical stability for at least the past three months,
- Age of 18-65,
- Voluntary participation in the study and signing the informed consent form,
Key exclusion criteria (7 listed)
- The presence of an orthopedic or neurological problem that will affect functional tests and muscle strength measurement,
- Acute decompensated heart failure,
- Unstable angina pectoris,
- Uncontrolled hypertension,
- The presence of problems that hinder communication,
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 |
|---|---|---|
| Virtual Reality GroupPatients assigned to Group 2 are involved in supervised exercise sessions 3 times a week during 8 weeks. Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality | Other | Virtual Reality Group |
Primary outcome
Muscle Strength
Time frame: at the beginning of the study and at the end of 8 week,
Lower and upper extremity strength: Measurement is performed by having the person being tested exert maximum effort against the device during the measurement, and the person conducting the test respond with maximum force in the opposite direction to prevent movement. The tests are repeated three times, and the average of the values is recorded in Newtons (N).
Hand Grip Strength
Time frame: at the beginning of the study and at the end of 8 weeks
The tests will be repeated three times, and the average of the values will be recorded in kilograms of force (kgF).
Functional capacity of lower extremity
Time frame: at the beginning of the study and at the end of 8 weeks
Six Minute Walking Test: Participants will be asked to walk as fast as possible at their own pace for 6 minutes on a 30-meter course. The distance walked by the patient will be recorded in meters.
Functional capacity of upper extremity
Time frame: at the beginning of the study and at the end of 8 weeks
Six Minute Pegboard and Ring Test: A wooden platform with bars will be used during the test. Two bars will be placed at shoulder level and the other two 20 cm above shoulder level. Ten rings, each weighing 14 grams, will be placed on the lower bars: ten on the right and ten on the left, for a total of 20 rings. Patients will be asked to place as many rings as possible from the lower bars to the upper bars and then back to the lower bars using both hands for 6 minutes. At the end of this time, the number of rings moved will be recorded as the the total score, and the resting time will be recorded in seconds.
Physical performance
Time frame: at the beginning of the study and at the end of 8 weeks
Short Physical Performance Battery: The test consists of 3 tests: walking 4 meters, standing up from a chair, and standing balance test. Each test is scored between 0-4. The scores obtained by the participants, ranging from 1-4, indicate the progressive performance required to complete the test according to the specified times. Walking test: Participants will be asked to walk 4 meters in a pre-marked corridor, and the time will be recorded and scored. The use of walking aids will be permitted, and saturation monitoring will be performed. Standing up from a chair test: Participants will be asked to stand up once from a seated position with their arms crossed over their chest. Patients who can do this will be asked to stand up and sit down five times as quickly as possible, and the time will be recorded. Standing balance test: 3 positions will be used; feet side-by-side and together, tandem, and half-tandem.
6 secondary outcomes
Dyspnea assessment
Time frame: at the beginning of the study and at the end of the 8 weeks
Physical Activity Level Assessment
Time frame: at the beginning of the study and at the end of 8 weeks
Fatigue Assessment
Time frame: at the beginning of the study and at the end of 8 weeks
Quality of life assessment
Time frame: at the beginning of the study and at the end of 8 weeks
Depression and anxiety assessment
Time frame: at the beginning of the study and at the end of the 8 weeks
Virtual Reality Experience Assessment
Time frame: at the beginning of the study and at the end of the 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Virtual Reality Group in people with Idiopathic Pulmonary Arterial Hypertension, run by Istanbul University - Cerrahpasa 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Muscle Strength (time frame: at the beginning of the study and at the end of 8 week,). The study lists 5 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 30 Apr 2026.