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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06362382
Other study ID # 2024-zxm-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 22, 2024
Est. completion date May 1, 2026

Study information

Verified date April 2024
Source China-Japan Friendship Hospital
Contact Xiaoming Zhou, MD
Phone +86 88396992
Email zhouxmcmu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 1, 2026
Est. primary completion date April 22, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

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 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.
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.

Locations

Country Name City State
China Fuwai Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in 6MWD after 3 months The participants will undergo 6-minute walk test (6WMT), and the 6-minute walk distance (6MWD) will be recoreded. 3th month after enrollment
Primary changes in muscle mass after 3 months Muscle mass will be measured by bioelectrical impedance analysis using the InBody S10 (Biospace, Seoul, Korea) or MC-780A (Tanita, Tokyo, Japan). 3th month after enrollment
Secondary peak VO2 The participants will undergo pulmonary function test. 3th month after enrollment
Secondary VO2peak% The participants will undergo pulmonary function test. 3th month after enrollment
Secondary VE/VCO2 slope The participants will undergo pulmonary function test. 3th month after enrollment
Secondary PET CO2 The participants will undergo pulmonary function test. 3th month after enrollment
Secondary Changes in muscle mass evaluated by CT Muscle mass will be measured by chest computed tomography (CT) images. 3th month after enrollment
Secondary Changes in grip strength Grip strength, a measure of muscle strength, was assessed using a grip dynamometer T.K.K. 5401 Grip-D (Takei Scientific Instruments Co, Ltd, Niigata, Japan). The patient was seated in a chair with the digital hand dynamometer placed at 90? elbow flexion and the upper arm resting on the torso. The patient held the dynamometer with maximum force for 3 s, resting and then alternating left and right twice. The average of the highest values on the left and right sides was taken. 3th month after enrollment
Secondary the time for 5 sit-to-stand test The participants will undergo 5 sit-to-stand test (5STS), and the time for 5STS will be recorded. 3th month after enrollment
Secondary Quality of life measured by SF-36 after 3 months The participants will undergo SF-36 questionnaire survey, and the score will be recorded. 3th month after enrollment
Secondary Quality of life measured by SF-36 after 6 months The participants will undergo SF-36 questionnaire survey, and the score will be recorded. 6th month after enrollment
Secondary Quality of life measured by emPHasis-10 after 3 months The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded. 3th month after enrollment
Secondary Quality of life measured by emPHasis-10 after 6 months The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded. 6th month after enrollment
Secondary Changes in WHO Cardiac Function Classification The participants will Classificated according to the WHO Cardiac Function Classification. 3th month after enrollment
Secondary Change in NT-proBNP The participants will undergo examination for NT-proBNP in serum. 3th month after enrollment
Secondary Change in TAPSE by cardiac doppler ultrasound The participants will undergo cardiac doppler ultrasound, and the tricuspid annular plane systolic excursion (TAPSE) will be recorded. 3th month after enrollment
Secondary Changes in hemodynamic indice after 6 months The hemodynamic indice will be measured by right heart catheter and recorded. 6th month after enrollment
Secondary Changes in sleep quality score after 3 months The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded. 3th month after enrollment
Secondary Changes in sleep quality score after 6 months The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded. 6th month after enrollment
Secondary Changes in psychosocial score after 3 months The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded. 3th month after enrollment
Secondary Changes in psychosocial score after 6 months The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded. 6th month after enrollment
Secondary All-cause mortality in 3 months All-cause mortality will be recorded. 3th month after enrollment
Secondary All-cause mortality in 6 months All-cause mortality will be recorded. 6th month after enrollment
Secondary The occurrence rate of primary events in pulmonary hypertension in 3 months The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment. 3th month after enrollment
Secondary The occurrence rate of primary events in pulmonary hypertension in 6 months The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment. 6th month after enrollment
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