Elevated Pulmonary Artery Pressure
Conditions
Keywords
Elevated pulmonary artery pressure, pulmonary hypertension, synchronous telerehabilitation, exercise capacity, pulmonary function, quality of life
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.
Interventions
BEHAVIORALSynchronous 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.
BEHAVIORALBreathing 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.
Sponsors
Marmara University
Tokat Gaziosmanpasa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to either a synchronous telerehabilitation group or a control group. The synchronous telerehabilitation group will receive 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue severity measured by the Fatigue Severity Scale | Baseline and at 8 weeks | Change in fatigue severity assessed using the Fatigue Severity Scale. The Fatigue Severity Scale is a 9-item patient-reported outcome measure assessing the severity and impact of fatigue. Each item is scored from 1 to 7. Total score can be calculated as the sum of all items, ranging from 9 to 63, or as the mean item score, ranging from 1 to 7. Higher scores indicate greater fatigue severity and a worse outcome. |
| Physical activity level | Baseline and at 8 weeks | Change in physical activity level assessed using the International Physical Activity Questionnaire-Short Form. |
| Anxiety and depression measured by the Hospital Anxiety and Depression Scale | Baseline and at 8 weeks | Change in anxiety and depression levellevel assessed using the Hospital Anxiety and Depression Scale. The Hospital Anxiety and Depression Scale is a 14-item self-report questionnaire developed to assess psychological distress in patients with physical health problems. It consists of 2 subscales, anxiety and depression, with 7 items in each subscale. Each item is scored from 0 to 3. Total scores range from 0 to 42, with higher scores indicating worse psychological status and a worse outcome. |
| Pulmonary function parameters | Baseline and at 8 weeks | Change in pulmonary function parameters including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio. |
| Quality of life measured by the Short Form-36 (SF-36) | Baseline and at 8 weeks | Change in health-related quality of life assessed using the Short Form-36 questionnaire. The 36-Item Short Form Survey (SF-36) is a validated self-report questionnaire used to assess health-related quality of life. It includes 8 domains: physical functioning, bodily pain, general health perception, role limitations due to physical problems, role limitations due to emotional problems, social functioning, mental health, and vitality. Scores range from 0 to 100, with higher scores indicating better health-related quality of life and a better outcome. |
| Independence in activities of daily living measured by the Barthel Index | Baseline and at 8 weeks | Change in functional independence in activities of daily living assessed using the Barthel Index. The Barthel Index is a standardized measure used to assess independence in activities of daily living. Scores range from 0 to 100, with higher scores indicating greater independence in daily activities and a better outcome. A score of 100 indicates full independence, while lower scores indicate increasing levels of dependency. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMehmet Armağan Physiotherapist, Msc
STUDY_DIRECTORAysel Yıldız Özer, PhD
Marmara University
Outcome results
None listed