Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Pulmonary Hypertension

Treatments: Behavioral: health propaganda and education; Behavioral: tele-rehabilitation training

Study type: Interventional

Funder types: Other

Identifiers

NCT06362382

2024-zxm-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

tele-rehabilitation training group

Experimental group

Description:

During their stay in the hospital, the patients were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle ofstandardized training. 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.

Treatment:

Behavioral: tele-rehabilitation training

control group

Active Comparator group

Description:

During their stay in the hospital, participants of the control group received health propaganda and education (7 days ± 3 days 1 week/times). After discharge from the hospital, the control group followed their daily routine.

Treatment:

Behavioral: health propaganda and education