Actively Recruiting
Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Quality of Life in Pulmonary Hypertension: a Prospective Single-center Randomized Controlled Study
Led by China-Japan Friendship Hospital · Updated on 2025-02-10
80
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension. The study aims to determine if tele-rehabilitation training can improve patients' prognostic function and quality of life compared to a control group receiving only health education and continuing their usual routine. This is a prospective single-center randomized controlled study led by China-Japan Friendship Hospital. Participants in the tele-rehabilitation group receive a full cycle of standardized training during their hospital stay, guided by a rehabilitation trainer and psychotherapist. After discharge, they perform 3 to 5 daily training sessions per week for three months, with weekly supervision and support via an online community. The control group receives health education during their hospital stay and follows their usual routine after discharge. The rehabilitation program includes impedance training and involves a professional team of cardiologists, trainers, psychotherapists, and radiologists. During the study, participants visit the clinic after three months for evaluations, with an optional extended follow-up up to six months. Researchers will measure changes in walking distance and muscle mass as primary outcomes. Secondary outcomes include assessments of peak oxygen uptake, muscle strength, cardiac function, quality of life, sleep quality, psychosocial scores, mortality rates, and pulmonary hypertension events. Data collection involves telemetry monitoring, photographs, and video recordings to track adherence and progress throughout the program.
CONDITIONS
Brief Title
Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years old
- Pulmonary hypertension defined by mPAP > 20 mmHg, PAWP ≤ 15 mmHg, and PVR > 2 WU measured by right heart catheterization
- Diagnosis of Arterial Pulmonary Hypertension, pulmonary hypertension related to lung disease, or Chronic Thromboembolic Pulmonary Hypertension
- No syncope or fainting episodes during walking or recovery
- No serious arrhythmias caused by rest or exercise such as ventricular tachycardia, ventricular fibrillation, or Class III atrioventricular block
- Stable medication regimen for at least 3 months before randomization and no organized exercise training in prior 3 months
- Proficient in using smartphones and monitoring devices
- Signed informed consent form
You will not qualify if you...
- Presence of venous thromboembolism (VTE)
- Acute pulmonary embolism
- Low-intensity exercise (<3 METs) or angina symptoms during recovery
- Abnormal hemodynamics during exercise such as no rise or fall in systolic blood pressure or arrhythmias
- Severe psychological or cognitive disorders
- Inability to perform exercise due to neurological or musculoskeletal dysfunction
- Scheduled for pulmonary artery balloon dilation or endarterectomy within 6 months for CTEPH
- Other serious diseases such as malignant tumors, pulmonary tuberculosis, hyperthyroidism, or severe depression
- Pregnancy
- Refusal to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days ± 3 days
Participants stay in the hospital for a complete cycle of standardized rehabilitation training or health education, accompanied by trainers and psychotherapists.
Daily visits during hospital stay
Duration - 3 months
After discharge, participants in the tele-rehabilitation group perform 3-5 weekly training sessions with intensive online supervision, while control group participants follow their daily routine.
3-5 weekly training sessions and at least 1 online supervision visit per week for tele-rehabilitation group; no required visits for control group
Duration - Up to 6 months
Participants are monitored for quality of life and clinical outcomes up to 6 months after enrollment.
Visits at 3 months and 6 months after enrollment
Trial Site Locations
Total: 1 location
1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
X
Xiaoming Zhou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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