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

Overview

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.

Interventions

• Behavioral 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 vide
• 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.

Primary outcome measures

• changes in 6MWD after 3 months [Time frame: 3th month after enrollment]
• changes in muscle mass after 3 months [Time frame: 3th month after enrollment]

Secondary outcome measures (12)

• peak VO2 [Time frame: 3th month after enrollment]
• VO2peak% [Time frame: 3th month after enrollment]
• VE/VCO2 slope [Time frame: 3th month after enrollment]
• PET CO2 [Time frame: 3th month after enrollment]
• Changes in muscle mass evaluated by CT [Time frame: 3th month after enrollment]
• Changes in grip strength [Time frame: 3th month after enrollment]
• the time for 5 sit-to-stand test [Time frame: 3th month after enrollment]
• Quality of life measured by SF-36 after 3 months [Time frame: 3th month after enrollment]
• Quality of life measured by SF-36 after 6 months [Time frame: 6th month after enrollment]
• Quality of life measured by emPHasis-10 after 3 months [Time frame: 3th month after enrollment]
• Quality of life measured by emPHasis-10 after 6 months [Time frame: 6th month after enrollment]
• Changes in WHO Cardiac Function Classification [Time frame: 3th month after enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Hospital — Beijing

Identifiers

NCT: NCT06362382 · 2024-zxm-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗