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

23. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

32

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Turecko (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turecko (Türkiye), 34180
        • Istanbul University-Cerrahpaşa/ Cardiology Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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,

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Jiný: 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
Žádný zásah: Control Group
Patients assigned to Group 2 will not included any intervention

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Muscle Strength
Časové okno: 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).
at the beginning of the study and at the end of 8 week,
Hand Grip Strength
Časové okno: 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).
at the beginning of the study and at the end of 8 weeks
Functional capacity of lower extremity
Časové okno: 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.
at the beginning of the study and at the end of 8 weeks
Functional capacity of upper extremity
Časové okno: 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.
at the beginning of the study and at the end of 8 weeks
Physical performance
Časové okno: 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.
at the beginning of the study and at the end of 8 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Dyspnea assessment
Časové okno: at the beginning of the study and at the end of the 8 weeks
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.
at the beginning of the study and at the end of the 8 weeks
Physical Activity Level Assessment
Časové okno: at the beginning of the study and at the end of 8 weeks
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.
at the beginning of the study and at the end of 8 weeks
Fatigue Assessment
Časové okno: at the beginning of the study and at the end of 8 weeks
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.
at the beginning of the study and at the end of 8 weeks
Quality of life assessment
Časové okno: at the beginning of the study and at the end of 8 weeks
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.
at the beginning of the study and at the end of 8 weeks
Depression and anxiety assessment
Časové okno: at the beginning of the study and at the end of the 8 weeks
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.
at the beginning of the study and at the end of the 8 weeks
Virtual Reality Experience Assessment
Časové okno: at the beginning of the study and at the end of the 8 weeks
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.
at the beginning of the study and at the end of the 8 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Istanbul University - Cerrahpasa

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

31. ledna 2026

Primární dokončení (Odhadovaný)

1. ledna 2027

Dokončení studie (Odhadovaný)

1. ledna 2027

Termíny zápisu do studia

První předloženo

19. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. dubna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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