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

Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Quality of Life in Pulmonary Hypertension: a Prospective Single-center Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Behavioral: tele-rehabilitation training; Behavioral: health propaganda and education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoming Zhou, MD; Phone Number: +86 88396992; Email: zhouxmcmu@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital
      • Contact: Xiaoming Zhou, MD; Phone Number: +86 88396992; Email: zhouxmcmu@163.com
      • Principal Investigator: Xiaoming Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak VO2	The participants will undergo pulmonary function test.	3th month after enrollment
VO2peak%	The participants will undergo pulmonary function test.	3th month after enrollment
VE/VCO2 slope	The participants will undergo pulmonary function test.	3th month after enrollment
PET CO2	The participants will undergo pulmonary function test.	3th month after enrollment
Changes in muscle mass evaluated by CT	Muscle mass will be measured by chest computed tomography (CT) images.	3th month after enrollment
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
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
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
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
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
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
Changes in WHO Cardiac Function Classification	The participants will Classificated according to the WHO Cardiac Function Classification.	3th month after enrollment
Change in NT-proBNP	The participants will undergo examination for NT-proBNP in serum.	3th month after enrollment
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
Changes in hemodynamic indice after 6 months	The hemodynamic indice will be measured by right heart catheter and recorded.	6th month after enrollment
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
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
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
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
All-cause mortality in 3 months	All-cause mortality will be recorded.	3th month after enrollment
All-cause mortality in 6 months	All-cause mortality will be recorded.	6th month after enrollment
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
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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 22, 2024
• Primary Completion (Estimated): April 22, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 2024-zxm-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No