Pulmonary HypertensionNCT06362382
Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension
A study testing tele-rehabilitation training and health propaganda and education in people with Pulmonary Hypertension, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- tele-rehabilitation training and health propaganda and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Xiaoming Zhou, MD, +86 88396992, zhouxmcmu@163.com
Xiaoming Zhou, MD
About this study
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
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.
Read more
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- tele-rehabilitation training, health propaganda and education
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-rehabilitation trainingBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| tele-rehabilitation training group | Experimental | 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. Receives: Behavioral: tele-rehabilitation training |
| control group | Active comparator | 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. Receives: Behavioral: health propaganda and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3th month after enrollment
Secondary outcomes (23)
peak VO2
The participants will undergo pulmonary function test.
Measured: 3th month after enrollment
VO2peak%
The participants will undergo pulmonary function test.
Measured: 3th month after enrollment
VE/VCO2 slope
The participants will undergo pulmonary function test.
Measured: 3th month after enrollment
PET CO2
The participants will undergo pulmonary function test.
Measured: 3th month after enrollment
Changes in muscle mass evaluated by CT
Muscle mass will be measured by chest computed tomography (CT) images.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6th month after enrollment
Changes in WHO Cardiac Function Classification
The participants will Classificated according to the WHO Cardiac Function Classification.
Measured: 3th month after enrollment
Change in NT-proBNP
The participants will undergo examination for NT-proBNP in serum.
Measured: 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.
Measured: 3th month after enrollment
Changes in hemodynamic indice after 6 months
The hemodynamic indice will be measured by right heart catheter and recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6th month after enrollment
All-cause mortality in 3 months
All-cause mortality will be recorded.
Measured: 3th month after enrollment
All-cause mortality in 6 months
All-cause mortality will be recorded.
Measured: 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.
Measured: 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.
Measured: 6th month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start22 Apr 2024
- Primary completion22 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362382
- Sponsor's protocol ID
- 2024-zxm-01
- Status last verified
- Feb 2025
- First submitted
- 9 Apr 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06362382
- Acronym / sponsor ID
- 2024-zxm-01
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tele-rehabilitation training group | Experimental | Behavioral: tele-rehabilitation trainingDuring 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. |
| control group | Active comparator | Behavioral: health propaganda and educationDuring 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tele-rehabilitation trainingDuring 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. | Behavioural | tele-rehabilitation training group |
| health propaganda and educationDuring 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. | Behavioural | control group |
Primary outcome
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.
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).
23 secondary outcomes
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
Change in NT-proBNP
Time frame: 3th month after enrollment
Change in TAPSE by cardiac doppler ultrasound
Time frame: 3th month after enrollment
Changes in hemodynamic indice after 6 months
Time frame: 6th month after enrollment
Changes in sleep quality score after 3 months
Time frame: 3th month after enrollment
Changes in sleep quality score after 6 months
Time frame: 6th month after enrollment
Changes in psychosocial score after 3 months
Time frame: 3th month after enrollment
Changes in psychosocial score after 6 months
Time frame: 6th month after enrollment
All-cause mortality in 3 months
Time frame: 3th month after enrollment
All-cause mortality in 6 months
Time frame: 6th month after enrollment
The occurrence rate of primary events in pulmonary hypertension in 3 months
Time frame: 3th month after enrollment
The occurrence rate of primary events in pulmonary hypertension in 6 months
Time frame: 6th month after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-rehabilitation training and health propaganda and education in people with Pulmonary Hypertension, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Zhou, MD (+86 88396992, zhouxmcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in 6MWD after 3 months (time frame: 3th month after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.