Virtual Reality in Patients With Pulmonary Hypertension: A Randomized Controlled Trial
2026年4月23日 更新者：Gamze Öztürk、Istanbul University - Cerrahpasa
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Fatih
-
Istanbul、Fatih、土耳其（türkiye）、34180
- Istanbul University-Cerrahpaşa/ Cardiology Institute
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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,
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Virtual Reality Group
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
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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
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无干预：Control Group
Patients assigned to Group 2 will not included any intervention
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle Strength
大体时间：at the beginning of the study and at the end of 8 week,
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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).
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at the beginning of the study and at the end of 8 week,
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Hand Grip Strength
大体时间：at the beginning of the study and at the end of 8 weeks
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The tests will be repeated three times, and the average of the values will be recorded in kilograms of force (kgF).
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at the beginning of the study and at the end of 8 weeks
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Functional capacity of lower extremity
大体时间：at the beginning of the study and at the end of 8 weeks
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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.
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at the beginning of the study and at the end of 8 weeks
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Functional capacity of upper extremity
大体时间：at the beginning of the study and at the end of 8 weeks
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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.
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at the beginning of the study and at the end of 8 weeks
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Physical performance
大体时间：at the beginning of the study and at the end of 8 weeks
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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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dyspnea assessment
大体时间：at the beginning of the study and at the end of the 8 weeks
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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.
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at the beginning of the study and at the end of the 8 weeks
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Physical Activity Level Assessment
大体时间：at the beginning of the study and at the end of 8 weeks
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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.
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at the beginning of the study and at the end of 8 weeks
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Fatigue Assessment
大体时间：at the beginning of the study and at the end of 8 weeks
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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.
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at the beginning of the study and at the end of 8 weeks
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Quality of life assessment
大体时间：at the beginning of the study and at the end of 8 weeks
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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.
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at the beginning of the study and at the end of 8 weeks
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Depression and anxiety assessment
大体时间：at the beginning of the study and at the end of the 8 weeks
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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.
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at the beginning of the study and at the end of the 8 weeks
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Virtual Reality Experience Assessment
大体时间：at the beginning of the study and at the end of the 8 weeks
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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.
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at the beginning of the study and at the end of the 8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月31日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年1月1日
研究注册日期
首次提交
2026年4月19日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025/574
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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