NCT06362382 Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension
| NCT ID | NCT06362382 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2026-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-04-22 with a primary completion date of 2026-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 1\. combined with VTE. * 2\. acute pulmonary embolism. * 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. * 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. * 8\. patients with a combination of other consumptive underlying diseases, such as malignant tumors, pulmonary tuberculosis, hyperthyroidism, severe depression, etc. * 9\. pregnancy. * 10\. refused to sign the informed consent form.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06362382 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06362382 currently recruiting?
Yes, NCT06362382 is actively recruiting participants. Contact the research team at zhouxmcmu@163.com for enrollment information.
Where is the NCT06362382 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06362382 clinical trial?
NCT06362382 is sponsored by China-Japan Friendship Hospital. The trial plans to enroll 80 participants.