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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
32
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Fatih
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Istanbul、Fatih、トルコ（Türkiye）、34180
- Istanbul University-Cerrahpaşa/ Cardiology Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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,
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Control Group
Patients assigned to Group 2 will not included any intervention
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle Strength
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dyspnea assessment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月31日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年4月19日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月23日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025/574
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はい
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