efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs (ASSIST)
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|ClinicalTrials.gov Identifier: NCT03102346|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : April 16, 2019
Home-based CR (HBCR) was reported to improve the clinical outcomes of coronary artery disease (CAD) patients. There is no data published to investigate whether HBCR is also effective for Chinese CAD patients who have been revascularized.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI (Percutaneous Coronary Intervention) procedure. This is a multicenter, randomized, controlled and observational study.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: home-based cardiac rehabilitation||Not Applicable|
Numerous studies have revealed that cardiac rehabilitation (CR) after myocardial Cardiac rehabilitation (CR) after revascularization results in better clinical outcomes, and have been strongly recommended for patients with coronary artery disease. In China, as compared to the exponential increase of PCI (Percutaneous Coronary Intervention) volume, only a very small amount of hospitals are able to develop CR programs. There is no large-scale study to explore the feasible CR pattern either. Home-based CR might be more favorable and practical for so many Chinese revascularized coronary artery disease (CAD) patients due to its feasibility and flexibility as well as low medical cost.
This trial was designed to investigate the safety and efficacy of CR program at home for Chinese patients who underwent PCI procedure. This is a multicenter, randomized, controlled and observational study. The efficacy and safety of Home-based CR (HBCR) in revascularized patients will be evaluated through observation of its clinical characteristics and safety indicators. The study will involve 14 sites nationwide, with an expected sample size of 2,000 followed up for 12 months. The primary endpoints is the incidence of composite major adverse cardiac and cerebrovascular events (MACCE,death from any cause, nonfatal myocardial infarction, revascularization, stroke).Secondary endpoints are defined as decrease of hospitalization due to refractory angina pectoris，the improvements of cardiorespiratory fitness,life quality,as well as angina pectoris.
The subjects will be randomized into 2 different groups, HBCR group and control group. After comprehensive evaluation, the orders from CR staff will be given. Besides the routine health education in both groups, the subjects in HBCR group will be further introduced the instructions of exercise training. The effect of HBCR on cardiorespiratory fitness, improvement of angina, cardiac function, quality of life, levels of anxiety and depression, as well as risk factor profile will also be evaluated. The investigators also aim to explore the factors which influence the adherence of subjects to our HBCR program.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Perspective Randomized Controlled Clinical Trial to Investigate the Effect of Home-based Cardiac Rehabilitation Monitored by Mobile Phone Interaction on Exercise Capacity and One-year Clinical Outcome in Chinese Revascularized Patients|
|Actual Study Start Date :||November 9, 2017|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Home-based Cardiac Rehabilitation group
remote instructed exercise training at home
Other: home-based cardiac rehabilitation
The exercise training includes aerobic exercise (fast walking or cycling ,30-40 minutes per day,5-6 times a week), stretching exercise (15 minutes every time, 5-6 times a week), and resistance and balance training (each of 15 minutes every time, twice to 3 times a week).
Other Name: exercise training at home
No Intervention: routine group
no instructed exercise training
- MACCE(death, nonfatal myocardial infarction, revascularization, stroke) [ Time Frame: during 12 months ]defined as the incidence of composite MACCE.
- improvement of hospitalization due to refractory angina pectoris [ Time Frame: during 12 months ]improvement of hospitalization due to refractory angina pectoris which need to be treated in hospital
- improvement of cardiorespiratory fitness [ Time Frame: during 12 months ]peak oxygen uptake adjusted by body weight measured by cardiopulmonary exercise test
- improvement of life quality [ Time Frame: during 12 months ]measured by medical outcomes study 36-item short form health survey
- improvement of angina pectoris [ Time Frame: during 12 months ]measured by Seattle Angina Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102346
|Contact: Jing Ma, MD,PHDemail@example.com|
|Principal Investigator:||Yundai Chen, MD,PHD||Director of department of Cardiology, Chinese PLA General Hospital|