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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362382
• Other study ID #: 2024-zxm-01
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

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