Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure

NCT07535398 | Recruiting

• 1 other identifier: 09.2024.165
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Elevated Pulmonary Artery Pressure

Keywords

Elevated pulmonary artery pressure; pulmonary hypertension; synchronous telerehabilitation; exercise capacity; pulmonary function; quality of life

Outcome Measures

Primary Outcomes (2)

• Exercise Capacity

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

  Baseline and at 8 weeks

• 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.

  Baseline and at 8 weeks

Secondary Outcomes (6)

• Fatigue severity measured by the Fatigue Severity Scale

  Baseline and at 8 weeks

• Physical activity level

  Baseline and at 8 weeks

• Anxiety and depression measured by the Hospital Anxiety and Depression Scale

  Baseline and at 8 weeks

• Pulmonary function parameters

  Baseline and at 8 weeks

• Quality of life measured by the Short Form-36 (SF-36)

  Baseline and at 8 weeks

Study Arms (2)

Synchronous Telerehabilitation Group

EXPERIMENTAL

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.

Behavioral: Synchronous Telerehabilitation

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Breathing and Posture Exercises

Interventions

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.

Control Group

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.

Synchronous Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead
• Tokat Gaziosmanpasa University: collaborator

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Respiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Aysel Yıldız Özer, PhD

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Mehmet Armağan Physiotherapist, Msc

CONTACT

00903562521616; mehmetarm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TU (1)