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Набор по приглашению NCT07558460

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

Без фазы С лечением Idiopathic Pulmonary Arterial Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Reality Group.
Кому может быть актуально
Состояния в реестре: Idiopathic Pulmonary Arterial Hypertension. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Muscle Strength [Срок оценки: at the beginning of the study and at the end of 8 week,]
  • Hand Grip Strength [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Functional capacity of lower extremity [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Functional capacity of upper extremity [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Physical performance [Срок оценки: at the beginning of the study and at the end of 8 weeks]
Вторичные конечные точки (6)
  • Dyspnea assessment [Срок оценки: at the beginning of the study and at the end of the 8 weeks]
  • Physical Activity Level Assessment [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Fatigue Assessment [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Quality of life assessment [Срок оценки: at the beginning of the study and at the end of 8 weeks]
  • Depression and anxiety assessment [Срок оценки: at the beginning of the study and at the end of the 8 weeks]
  • Virtual Reality Experience Assessment [Срок оценки: at the beginning of the study and at the end of the 8 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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,

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT07558460 · 2025/574

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗