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Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure

ConditionElevated Pulmonary Artery Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Synchronous Telerehabilitation

    Behavioral

    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.

  • Breathing and Posture Exercises

    Behavioral

    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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Synchronous Telerehabilitation GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Capacity

Change in 6-minute walk distance assessed by the 6-minute walk test to evaluate functional capacity.

Time frame
Baseline and at 8 weeks
2

Dyspnea severity measured by the Modified Borg Dyspnea Scale

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.

Time frame
Baseline and at 8 weeks

Secondary outcomes

1

Fatigue severity measured by the Fatigue Severity Scale

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.

Time frame
Baseline and at 8 weeks
2

Physical activity level

Change in physical activity level assessed using the International Physical Activity Questionnaire-Short Form.

Time frame
Baseline and at 8 weeks
3

Anxiety and depression measured by the Hospital Anxiety and Depression Scale

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.

Time frame
Baseline and at 8 weeks
4

Pulmonary function parameters

Change in pulmonary function parameters including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio.

Time frame
Baseline and at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Tokat Gaziosmanpasa University

Collaborator

Source ClinicalTrials.gov
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