Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Quality of Life in Pulmonary Hypertension: a Prospective Single-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- changes in muscle mass after 3 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
changes in muscle mass after 3 months
时间窗: 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).
changes in 6MWD after 3 months
时间窗: 3th month after enrollment
The participants will undergo 6-minute walk test (6WMT), and the 6-minute walk distance (6MWD) will be recoreded.
次要结局
- VO2peak%(3th month after enrollment)
- Quality of life measured by emPHasis-10 after 3 months(3th month after enrollment)
- Changes in sleep quality score after 6 months(6th month after enrollment)
- Changes in psychosocial score after 6 months(6th month after enrollment)
- VE/VCO2 slope(3th month after enrollment)
- PET CO2(3th month after enrollment)
- the time for 5 sit-to-stand test(3th month after enrollment)
- peak VO2(3th month after enrollment)
- Quality of life measured by emPHasis-10 after 6 months(6th month after enrollment)
- Quality of life measured by SF-36 after 6 months(6th month after enrollment)
- Changes in grip strength(3th month after enrollment)
- Quality of life measured by SF-36 after 3 months(3th month after enrollment)
- Change in NT-proBNP(3th month after enrollment)
- Change in TAPSE by cardiac doppler ultrasound(3th month after enrollment)
- Changes in muscle mass evaluated by CT(3th month after enrollment)
- Changes in WHO Cardiac Function Classification(3th month after enrollment)
- Changes in psychosocial score after 3 months(3th month after enrollment)
- Changes in hemodynamic indice after 6 months(6th month after enrollment)
- All-cause mortality in 6 months(6th month after enrollment)
- Changes in sleep quality score after 3 months(3th month after enrollment)
- All-cause mortality in 3 months(3th month after enrollment)
- The occurrence rate of primary events in pulmonary hypertension in 6 months(6th month after enrollment)
- The occurrence rate of primary events in pulmonary hypertension in 3 months(3th month after enrollment)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital