Virtual Reality in Patients With Pulmonary Hypertension: A Randomized Controlled Trial

NCT07558460 | Enrolling By Invitation DMC

• 1 other identifier: 2025/574
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

idiopathic pulmonary arterial hypertension; immersive virtual reality; exercise

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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.

  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.

  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.

  at the beginning of the study and at the end of 8 weeks

Secondary Outcomes (6)

• Dyspnea assessment

  at the beginning of the study and at the end of the 8 weeks

• Physical Activity Level Assessment

  at the beginning of the study and at the end of 8 weeks

• Fatigue Assessment

  at the beginning of the study and at the end of 8 weeks

• Quality of life assessment

  at the beginning of the study and at the end of 8 weeks

• Depression and anxiety assessment

  at the beginning of the study and at the end of the 8 weeks

Study Arms (2)

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

Other: Virtual Reality Group

Control Group

NO INTERVENTION

Patients assigned to Group 2 will not included any intervention

Interventions

Virtual Reality Group OTHER

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

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa/ Cardiology Institute

Istanbul, Fatih, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 30, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)