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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Cardiac Rehabilitation group | Experimental | remote instructed exercise training at home |
|
| routine group | No Intervention | no instructed exercise training |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based cardiac rehabilitation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE(death, nonfatal myocardial infarction, revascularization, stroke) | defined as the incidence of composite MACCE. | during 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of hospitalization due to refractory angina pectoris | improvement of hospitalization due to refractory angina pectoris which need to be treated in hospital | during 12 months |
| improvement of cardiorespiratory fitness |
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Inclusion Criteria:
all of them
Exclusion Criteria (Enrollment):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ma, MD,PHD | Contact | 86-10-66935316 | crystalma_301@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen, MD,PHD | Director of department of Cardiology, Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First People's Hospital of Yunnan Province | Recruiting | Kunming | Yunnan | 650032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15492340 | Background | DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G. Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med. 2004 Oct 19;141(8):606-13. doi: 10.7326/0003-4819-141-8-200410190-00008. | |
| 8124838 | Background | Haskell WL, Alderman EL, Fair JM, Maron DJ, Mackey SF, Superko HR, Williams PT, Johnstone IM, Champagne MA, Krauss RM, et al. Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). Circulation. 1994 Mar;89(3):975-90. doi: 10.1161/01.cir.89.3.975. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
peak oxygen uptake adjusted by body weight measured by cardiopulmonary exercise test
| during 12 months |
| improvement of life quality | measured by medical outcomes study 36-item short form health survey | during 12 months |
| improvement of angina pectoris | measured by Seattle Angina Questionnaire. | during 12 months |
| 6381770 | Background | Froelicher V, Jensen D, Genter F, Sullivan M, McKirnan MD, Witztum K, Scharf J, Strong ML, Ashburn W. A randomized trial of exercise training in patients with coronary heart disease. JAMA. 1984 Sep 14;252(10):1291-7. |
| 1853191 | Background | Newton M, Mutrie N, McArthur JD. The effects of exercise in a coronary rehabilitation programme. Scott Med J. 1991 Apr;36(2):38-41. doi: 10.1177/003693309103600203. |
| 23711446 | Background | Conraads VM, Van Craenenbroeck EM, Pattyn N, Cornelissen VA, Beckers PJ, Coeckelberghs E, De Maeyer C, Denollet J, Frederix G, Goetschalckx K, Hoymans VY, Possemiers N, Schepers D, Shivalkar B, Vanhees L. Rationale and design of a randomized trial on the effectiveness of aerobic interval training in patients with coronary artery disease: the SAINTEX-CAD study. Int J Cardiol. 2013 Oct 9;168(4):3532-6. doi: 10.1016/j.ijcard.2013.05.007. Epub 2013 May 24. |
| 21799272 | Background | Soga Y, Yokoi H, Amemiya K, Iwabuchi M, Nobuyoshi M. Safety and efficacy of exercise training after coronary stenting in patients with stable coronary artery disease. Circ J. 2011;75(10):2379-86. doi: 10.1253/circj.cj-11-0470. Epub 2011 Jul 28. |
| 23174552 | Background | Perez-Terzic CM. Exercise in cardiovascular diseases. PM R. 2012 Nov;4(11):867-73. doi: 10.1016/j.pmrj.2012.10.003. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |