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Enrolling by invitation NCT07558460

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

No phase Interventional Idiopathic Pulmonary Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Group.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Arterial Hypertension. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effectiveness of Exercise Training Applied Through Virtual Reality in Patients With Pulmonary Hypertension

Overview

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.

Interventions

  • Other Virtual Reality Group
    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

Primary outcome measures

  • Muscle Strength [Time frame: at the beginning of the study and at the end of 8 week,]
  • Hand Grip Strength [Time frame: at the beginning of the study and at the end of 8 weeks]
  • Functional capacity of lower extremity [Time frame: at the beginning of the study and at the end of 8 weeks]
  • Functional capacity of upper extremity [Time frame: at the beginning of the study and at the end of 8 weeks]
  • Physical performance [Time frame: at the beginning of the study and at the end of 8 weeks]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University-Cerrahpaşa/ Cardiology Institute — Istanbul

Identifiers

NCT: NCT07558460 · 2025/574

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗