The Effectiveness of Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 12
- Primary Endpoint
- Exercise Capacity
Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Synchronous Telerehabilitation Group
Participants with elevated pulmonary artery pressure identified by echocardiography (systolic pulmonary artery pressure ≥50 mmHg) who meet the study eligibility criteria will receive an 8-week synchronous telerehabilitation program. The program will be delivered 3 days per week, 30 minutes per session, under real-time physiotherapist supervision. The intervention will include aerobic, endurance, and strengthening exercises. Exercise intensity and progression will be individualized according to clinical status, baseline adaptation, and cardiopulmonary exercise test findings. Hemodynamic parameters, oxygen saturation, dyspnea, and fatigue will be monitored during sessions.
Intervention: Synchronous Telerehabilitation (Behavioral)
Control Group
Participants with elevated pulmonary artery pressure identified by echocardiography (systolic pulmonary artery pressure ≥50 mmHg) who meet the study eligibility criteria will perform breathing and posture exercises for 8 weeks. Participants in this group will continue routine care and receive weekly motivational follow-up by a physiotherapist. At the end of the study period, participants in the control group may be offered the exercise program if they wish to continue.
Intervention: Breathing and Posture Exercises (Behavioral)
Outcomes
Primary Outcomes
Exercise Capacity
Time Frame: Baseline and at 8 weeks
Change in 6-minute walk distance assessed by the 6-minute walk test to evaluate functional capacity.
Dyspnea severity measured by the Modified Borg Dyspnea Scale
Time Frame: Baseline and at 8 weeks
Change in dyspnea severity assessed using the Modified Borg Dyspnea Scale. The Modified Borg Dyspnea Scale is a subjective rating scale used to assess the severity of dyspnea at rest and/or during activity. Scores range from 0 to 10, with higher scores indicating greater dyspnea severity and a worse outcome.
Secondary Outcomes
- Physical activity level(Baseline and at 8 weeks)
- Pulmonary function parameters(Baseline and at 8 weeks)
- Fatigue severity measured by the Fatigue Severity Scale(Baseline and at 8 weeks)
- Anxiety and depression measured by the Hospital Anxiety and Depression Scale(Baseline and at 8 weeks)
- Quality of life measured by the Short Form-36 (SF-36)(Baseline and at 8 weeks)
- Independence in activities of daily living measured by the Barthel Index(Baseline and at 8 weeks)
Investigators
Aysel Yildiz
Professor
Marmara University