NCT06362382Recruiting
Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension
Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Quality of Life in Pulmonary Hypertension: a Prospective Single-center Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension，especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are: Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension？ Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis. Participants will: During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week. Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 22 Apr 2024
- Primary completion date
- 22 Apr 2026
- Lead sponsor
- China-Japan Friendship Hospital
- NCT number
- NCT06362382
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 22 Apr 2024 to the primary completion date, 22 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 3\. low-intensity exercise (\<3METs) or angina pectoris symptoms/signs during the recovery period.
- 4\. hemodynamic abnormality during exercise (especially systolic blood pressure doesn't rise or fall or arrhythmia occurs when the exercise load is increased).
- 5\. severe psycho-cognitive disorders.
- 8\. patients with a combination of other consumptive underlying diseases, such as malignant tumors, pulmonary tuberculosis, hyperthyroidism, severe depression, etc.
Other
- 1\. combined with VTE.
- 2\. acute pulmonary embolism.
- 6\. couldent do exercise due to the neurological or musculoskeletal dysfunction.
- 7\. patients with CTEPH who are scheduled to undergo percutaneous pulmonary artery balloon dilatation or pulmonary artery endarterectomy within 6 months.
- 9\. pregnancy.
- 10\. refused to sign the informed consent form.
Who the study is looking for
- 1\. age 18- 60 years old;
- 2\. PH were defined as: mPAP \> 20 mmHg, PAWP ≦ 15 mmHg and PVR \> 2 WU measured by right heart catheterization at sea level at rest;
- 3\. Arterial Pulmonary Hypertension (PAH), pulmonary hypertension associated with lung diseaseor and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) according to the WHO PH Classification;
- 4\. no syncope or syncopal aura during walking or recovery.
- 5\. no serious arrhythmia caused by rest or exercise such as ventricular tachycardia, ventricular fibrillation, Class III atrioventricular block, etc.
- 6\. stable medication and medication regimen for at least 3 months prior to randomization and no organized exercise training of any kind for at least 3 months prior to screening
- 7\. be proficient in the use of smartphones and monitoring devices;
- 8\. sign an informed consent form.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.