Clinical trial NCT06362382: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension
Official title: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Quality of Life in Pulmonary Hypertension: a Prospective Single-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: changes in 6MWD after 3 months
timeFrame: 3th month after enrollment
measure: changes in muscle mass after 3 months
timeFrame: 3th month after enrollment
Secondary outcomes:
measure: peak VO2
timeFrame: 3th month after enrollment
measure: VO2peak%
timeFrame: 3th month after enrollment
measure: VE/VCO2 slope
timeFrame: 3th month after enrollment
measure: PET CO2
timeFrame: 3th month after enrollment
measure: Changes in muscle mass evaluated by CT
timeFrame: 3th month after enrollment
measure: Changes in grip strength
timeFrame: 3th month after enrollment
measure: the time for 5 sit-to-stand test
timeFrame: 3th month after enrollment
measure: Quality of life measured by SF-36 after 3 months
timeFrame: 3th month after enrollment
measure: Quality of life measured by SF-36 after 6 months
timeFrame: 6th month after enrollment
measure: Quality of life measured by emPHasis-10 after 3 months
timeFrame: 3th month after enrollment
measure: Quality of life measured by emPHasis-10 after 6 months
timeFrame: 6th month after enrollment
measure: Changes in WHO Cardiac Function Classification
timeFrame: 3th month after enrollment
measure: Change in NT-proBNP
timeFrame: 3th month after enrollment
measure: Change in TAPSE by cardiac doppler ultrasound
timeFrame: 3th month after enrollment
measure: Changes in hemodynamic indice after 6 months
timeFrame: 6th month after enrollment
measure: Changes in sleep quality score after 3 months
timeFrame: 3th month after enrollment
measure: Changes in sleep quality score after 6 months
timeFrame: 6th month after enrollment
measure: Changes in psychosocial score after 3 months
timeFrame: 3th month after enrollment
measure: Changes in psychosocial score after 6 months
timeFrame: 6th month after enrollment
measure: All-cause mortality in 3 months
timeFrame: 3th month after enrollment
measure: All-cause mortality in 6 months
timeFrame: 6th month after enrollment
measure: The occurrence rate of primary events in pulmonary hypertension in 3 months
timeFrame: 3th month after enrollment
measure: The occurrence rate of primary events in pulmonary hypertension in 6 months
timeFrame: 6th month after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References: