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

NCT ID: NCT06362382

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2026-05-01

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tele-rehabilitation training group

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.

Group Type: EXPERIMENTAL

tele-rehabilitation training

Intervention Type: BEHAVIORAL

During their stay in the hospital, the patients were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training.

After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily （a total of 3 months）training sessions and intensive supervision and management by the online community at least once a week. All patients' routines were monitored by telemetry and data, photographs and video recordings were collected by a specialized agency.

The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved.

control group

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.

Group Type: ACTIVE_COMPARATOR

health propaganda and education

Intervention Type: BEHAVIORAL

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.

Interventions

tele-rehabilitation training

During their stay in the hospital, the patients were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training.

After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily （a total of 3 months）training sessions and intensive supervision and management by the online community at least once a week. All patients' routines were monitored by telemetry and data, photographs and video recordings were collected by a specialized agency.

The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved.

Intervention Type: BEHAVIORAL

health propaganda and education

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gang Hou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoming Zhou, MD

Role: CONTACT

zhouxmcmu@163.com

+86 88396992

Facility Contacts

Xiaoming Zhou, MD

Role: primary

zhouxmcmu@163.com

+86 88396992

Other Identifiers

2024-zxm-01

Identifier Type: -

Identifier Source: org_study_id