efficAcy and Safety of Home-baSed Cardiac rehabIlitation in ChineSe Revascularized patienTs

NCT ID: NCT03102346

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Home-based Cardiac Rehabilitation group

remote instructed exercise training at home

Group Type: EXPERIMENTAL

home-based cardiac rehabilitation

Intervention Type: 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).

routine group

no instructed exercise training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

exercise training at home

Eligibility Criteria

Inclusion Criteria

all of them

1. age range from 30 to 80.

2. coronary artery disease,revascularized with stent deployment.

3. New York Heart Association (NYHA) classification Class I-III.

4. Good cognitive level.

5. Ability to perform aerobic exercise.

6. Understand be able to use a mobile smart phone by himself or with help of family members.

7. Signature of informed consent. The informed consent will be valid for the duration of the trial or until the subject withdraws.

Exclusion Criteria

1. Presence of malignant arrhythmias such as ventricular fibrillation outside the acute phase of Acute myocardial infarction (AMI) (> 24 h after AMI), ventricular tachycardia, Atrioventricular block of 2nd degree and 3rd degree, Atrial fibrilation (FA) in patients with Wolf Parkinson White, fibrillation or paroxysmal atrial flutter with response ventricular quickly and hemodynamic deterioration, premature ventricular contractions increases during exertion, paroxysmal supraventricular tachycardia uncontrolled.

2. Hypotensive response to exercise.

3. acute myocardial infarction within 2 weeks

4. Poorly controlled hypertension baseline,hyperglycemia,respiratory failure.

5. severe pulmonary hypertension

6. acute phase of heart failure

7. Pathology of musculoskeletal, neurological or breathing that impair the ability of prolonged ambulation.

8. Pregnant women.

9. Subjects unable to give informed consent.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yun Dai Chen

Director, Head of Cardiology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yundai Chen, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Director of department of Cardiology, Chinese PLA General Hospital

Locations

the First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Ma, MD,PHD

Role: CONTACT

crystalma_301@126.com

86-10-66935316

Facility Contacts

YUNMEI ZHANG, MD

Role: primary

zym888198@sina.com

8613888182536

KE ZHUANG, MD

Role: backup

zhuangke@trails1.cn

8613888901747

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Other Identifiers

S2016-142-01

Identifier Type: -

Identifier Source: org_study_id