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NCT Number: NCT06362382

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Xiaoming Zhou, MD

CONTACT

[email protected]

+86 88396992

Xiaoming Zhou, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tele-rehabilitation training

Behavioral

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

Behavioral

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 outcomes

  1. changes in 6MWD after 3 months

    Time frame: 3th month after enrollment

    The participants will undergo 6-minute walk test (6WMT), and the 6-minute walk distance (6MWD) will be recoreded.

  2. changes in muscle mass after 3 months

    Time frame: 3th month after enrollment

    Muscle mass will be measured by bioelectrical impedance analysis using the InBody S10 (Biospace, Seoul, Korea) or MC-780A (Tanita, Tokyo, Japan).

Secondary outcomes

  1. peak VO2

    Time frame: 3th month after enrollment

    The participants will undergo pulmonary function test.

  2. VO2peak%

    Time frame: 3th month after enrollment

    The participants will undergo pulmonary function test.

  3. VE/VCO2 slope

    Time frame: 3th month after enrollment

    The participants will undergo pulmonary function test.

  4. PET CO2

    Time frame: 3th month after enrollment

    The participants will undergo pulmonary function test.

  5. Changes in muscle mass evaluated by CT

    Time frame: 3th month after enrollment

    Muscle mass will be measured by chest computed tomography (CT) images.

  6. Changes in grip strength

    Time frame: 3th month after enrollment

    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.

  7. the time for 5 sit-to-stand test

    Time frame: 3th month after enrollment

    The participants will undergo 5 sit-to-stand test (5STS), and the time for 5STS will be recorded.

  8. Quality of life measured by SF-36 after 3 months

    Time frame: 3th month after enrollment

    The participants will undergo SF-36 questionnaire survey, and the score will be recorded.

  9. Quality of life measured by SF-36 after 6 months

    Time frame: 6th month after enrollment

    The participants will undergo SF-36 questionnaire survey, and the score will be recorded.

  10. Quality of life measured by emPHasis-10 after 3 months

    Time frame: 3th month after enrollment

    The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded.

  11. Quality of life measured by emPHasis-10 after 6 months

    Time frame: 6th month after enrollment

    The participants will undergo emPHasis-10 questionnaire survey, and the score will be recorded.

  12. Changes in WHO Cardiac Function Classification

    Time frame: 3th month after enrollment

    The participants will Classificated according to the WHO Cardiac Function Classification.

  13. Change in NT-proBNP

    Time frame: 3th month after enrollment

    The participants will undergo examination for NT-proBNP in serum.

  14. Change in TAPSE by cardiac doppler ultrasound

    Time frame: 3th month after enrollment

    The participants will undergo cardiac doppler ultrasound, and the tricuspid annular plane systolic excursion (TAPSE) will be recorded.

  15. Changes in hemodynamic indice after 6 months

    Time frame: 6th month after enrollment

    The hemodynamic indice will be measured by right heart catheter and recorded.

  16. Changes in sleep quality score after 3 months

    Time frame: 3th month after enrollment

    The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded.

  17. Changes in sleep quality score after 6 months

    Time frame: 6th month after enrollment

    The sleep quality scores will be measured using Pittsburgh Sleep Quality Index and recorded.

  18. Changes in psychosocial score after 3 months

    Time frame: 3th month after enrollment

    The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded.

  19. Changes in psychosocial score after 6 months

    Time frame: 6th month after enrollment

    The psychosocial score will be measured using Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) and recorded.

  20. All-cause mortality in 3 months

    Time frame: 3th month after enrollment

    All-cause mortality will be recorded.

  21. All-cause mortality in 6 months

    Time frame: 6th month after enrollment

    All-cause mortality will be recorded.

  22. The occurrence rate of primary events in pulmonary hypertension in 3 months

    Time frame: 3th month after enrollment

    The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment.

  23. The occurrence rate of primary events in pulmonary hypertension in 6 months

    Time frame: 6th month after enrollment

    The primary events in pulmonary hypertension will be recorded, which includes aggravation of pulmonary hypertension, worsening of heart failure, and upgrading of medication treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoming Zhou, MD

CONTACT

[email protected]

+86 88396992

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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