Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure

Официальное название

The Effectiveness of Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure

Обзор

The goal of this clinical trial is to learn if synchronous telerehabilitation is effective in patients with elevated pulmonary artery pressure identified by echocardiography (systolic pulmonary artery pressure ≥50 mmHg). It will also evaluate the effects of telerehabilitation on exercise capacity, dyspnea, fatigue, functional status, and quality of life. The main questions it aims to answer are: Does synchronous telerehabilitation improve exercise and functional capacity in these patients? Does synchronous telerehabilitation improve dyspnea, fatigue, psychological status, and quality of life? Researchers will compare synchronous telerehabilitation with breathing and posture exercises to see if telerehabilitation provides greater clinical and functional benefit. Participants will: Be randomly assigned to one of 2 groups Follow an 8-week program, 3 times per week, for 30 minutes per session Perform aerobic, endurance, and strengthening exercises by synchronous telerehabilitation, or breathing and posture exercises in the control group Complete assessments before and after treatment

Подробное описание

Pulmonary hypertension is associated with impaired cardiopulmonary function, reduced aerobic capacity, decreased oxygen consumption, and exercise intolerance. Dyspnea, fatigue, reduced physical activity, and limitations in daily activities negatively affect functional status, psychological well-being, and quality of life in this patient population. Exercise-based rehabilitation has been reported to improve functional capacity, exercise performance, and overall well-being in patients with pulmonary vascular disease, despite earlier concerns that exercise might worsen symptoms in these patients.

Telerehabilitation refers to the delivery of rehabilitation services through telecommunication technologies. Synchronous telerehabilitation is based on real-time interaction between the clinician and the patient and may be a useful, accessible, and safe alternative when attendance at center-based rehabilitation is difficult. Previous studies have shown beneficial effects of exercise-based telerehabilitation in cardiopulmonary populations; however, evidence regarding synchronous telerehabilitation in patients with elevated pulmonary artery pressure remains limited.

The aim of this study is to investigate the effectiveness of a synchronous telerehabilitation program in patients with elevated pulmonary artery pressure identified by echocardiography, defined as systolic pulmonary artery pressure (sPAP) of 50 mmHg or higher. Participants will be randomly assigned to either a synchronous telerehabilitation group or a control group. The telerehabilitation group will receive a supervised program including aerobic, endurance, and strengthening exercises, while the control group will perform breathing and posture exercises. Both groups will participate in the program 3 days per week, 30 minutes per session, for 8 weeks. At the end of the 8-week period, participants in the control group who wish to continue may be offered the synchronous rehabilitation program.

The study will evaluate the effects of the intervention on cardiopulmonary and functional outcomes, including dyspnea, fatigue, physical activity level, psychological status, pulmonary function, exercise capacity, functional capacity, and quality of life. Assessments will be performed before and after the intervention period using standardized outcome measures.

The findings of this study may help clarify the role of synchronous telerehabilitation as an accessible rehabilitation strategy for patients with elevated pulmonary artery pressure, particularly for individuals who have difficulty accessing in-person rehabilitation services. Given the limited evidence in this specific population, this study is expected to contribute clinically relevant data regarding the effectiveness of remote exercise-based rehabilitation.

Вмешательства

• Поведенческое Synchronous Telerehabilitation
  A supervised synchronous telerehabilitation program delivered via videoconferencing, including aerobic, endurance, and strengthening exercises for 8 weeks, 3 times per week, 30 minutes per session. The program will be individualized based on participant tolerance and clinical findings, with monitoring of symptoms and physiologic responses during exercise.
• Поведенческое Breathing and Posture Exercises
  A control intervention consisting of breathing exercises, positions to relieve breathing discomfort, breathing control techniques, energy conservation strategies, and posture exercises, performed for 8 weeks, together with routine care and weekly motivational follow-up.

Первичные конечные точки

• Exercise Capacity [Срок оценки: Baseline and at 8 weeks]
• Dyspnea severity measured by the Modified Borg Dyspnea Scale [Срок оценки: Baseline and at 8 weeks]

Вторичные конечные точки (6)

• Fatigue severity measured by the Fatigue Severity Scale [Срок оценки: Baseline and at 8 weeks]
• Physical activity level [Срок оценки: Baseline and at 8 weeks]
• Anxiety and depression measured by the Hospital Anxiety and Depression Scale [Срок оценки: Baseline and at 8 weeks]
• Pulmonary function parameters [Срок оценки: Baseline and at 8 weeks]
• Quality of life measured by the Short Form-36 (SF-36) [Срок оценки: Baseline and at 8 weeks]
• Independence in activities of daily living measured by the Barthel Index [Срок оценки: Baseline and at 8 weeks]

Критерии участия

Критерии включения

• Adults aged 18 to 65 years
• Elevated pulmonary artery pressure identified by echocardiography, defined as systolic pulmonary artery pressure (sPAP) of 50 mmHg or higher
• Clinically stable and receiving medical treatment under cardiology follow-up World Health Organization functional class I or II
• New York Heart Association (NYHA) functional class I or II
• Living with a caregiver, family member, or another person who can provide assistance if needed
• Access to the internet and adequate visual, cognitive, and functional ability to participate in videoconference-based sessions
• Willing to participate and able to provide informed consent

Критерии исключения

• Requirement for oxygen therapy
• Musculoskeletal problems limiting participation in exercise
• Ongoing treatment for psychiatric or psychological disorders
• Cognitive impairment based on Mini-Mental State Examination findings
• Severe chronic obstructive pulmonary disease (COPD)
• Other significant cardiac disease that may interfere with participation or assessment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Tokat Gaziosmanpaşa University — Tokat Province

Идентификаторы

NCT: NCT07535398 · 09.2024.165

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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