- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535398
Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure
The Effectiveness of Telerehabilitation in Patients With Elevated Pulmonary Artery Pressure
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
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Armağan Physiotherapist, Msc
- Phone Number: 00903562521616
- Email: mehmetarm@gmail.com
Study Locations
-
-
-
Tokat Province, Turkey (Türkiye)
- Recruiting
- Tokat Gaziosmanpasa University
-
Contact:
- Mehmet Armağan
- Phone Number: 00903562521616
- Email: mehmetarm@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and at 8 weeks
|
|
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.
|
Baseline and at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level
Time Frame: Baseline and at 8 weeks
|
Change in physical activity level assessed using the International Physical Activity Questionnaire-Short Form.
|
Baseline and at 8 weeks
|
|
Pulmonary function parameters
Time Frame: 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.
|
Baseline and at 8 weeks
|
|
Fatigue severity measured by the Fatigue Severity Scale
Time Frame: 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.
|
Baseline and at 8 weeks
|
|
Anxiety and depression measured by the Hospital Anxiety and Depression Scale
Time Frame: 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.
|
Baseline and at 8 weeks
|
|
Quality of life measured by the Short Form-36 (SF-36)
Time Frame: 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.
|
Baseline and at 8 weeks
|
|
Independence in activities of daily living measured by the Barthel Index
Time Frame: 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.
|
Baseline and at 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Aysel Yıldız Özer, PhD, Marmara University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2024.165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Elevated Pulmonary Artery Pressure
-
University Hospital Inselspital, BerneCompletedPulmonary Artery PressureSwitzerland
-
Medical University of GrazEnrolling by invitationPulmonary Hypertension | Elevated Mean Pulmonary Arterial Pressure | Normal Mean Pulmonary Arterial PressureAustria
-
Mati Therapeutics Inc.CompletedElevated Intraocular Pressure (IOP)United States
-
University Hospital, MontpellierCompletedElevated Left Atrial PressureFrance
-
University of LjubljanaRecruitingHealthy | Prehypertension (Elevated Blood Pressure) or HypertensionSlovenia
-
University Health Network, TorontoCompletedElevated Intracranial Pressure (ICP)Canada
-
Lashmi VenkatraghavanUniversity Health Network, TorontoCompletedElevated Intracranial Pressure (ICP)Canada
-
University of CologneCompletedControl of Elevated Eye Pressure by Local and Systemic TherapyGermany
-
Lv YingjuanCompletedIntraocular PressureChina
-
MTI UniversityCompletedReducing the Elevated Blood Pressure for Diabetic Hypertensive PatientsEgypt
Clinical Trials on Synchronous Telerehabilitation
-
Biruni UniversityNot yet recruitingPremature Birth of Newborn | Motor Delay | Risky BabyTurkey (Türkiye)
-
Marmara UniversityCompletedHemiparetic Cerebral PalsyTurkey
-
Inonu UniversityFirat UniversityRecruitingTelerehabilitation | Anklyosing SpondylitisTurkey (Türkiye)
-
Bitlis Eren UniversityMarmara UniversityCompletedCOVID-19 | TelerehabilitationTurkey
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
University of PatrasRecruitingUrinary Incontinence,StressGreece
-
University of HaifaCompletedAutism Spectrum DisorderIsrael
-
Universiti Sains MalaysiaRecruitingPsychological Stress | Aerobic Exercise | Medical StudentsChina
-
Istanbul University - CerrahpasaNot yet recruitingExercise | Telerehabilitation | Familial Mediterranean Fever (FMF )Turkey
-
Emory UniversityNational Institute on Aging (NIA)Recruiting