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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoming Zhou, MD | Contact | +86 88396992 | zhouxmcmu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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