A comparative study assessing the secondary prevention efficacy between center-based vs. home-based cardiact rehabilitation in patients with cardiovascular diseases
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0006385
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1040
1) Male or female patients aged 18-75 who had a history of recent admission in 6 mo for 1) congestive heart failure (LVEF =40%) or 2) acute myocardial infarction with enhanced risk factors (1 =)
* enhanced risk factors of MI : DM, history of old myocardial infarction, history of congestive heart failure, old stroke, peripheral artery obstructive disease, Killip calss 2=, left main disease or coronary artery multivessel (2=) disease , LVEF =40%
1) exercise is impossible or very difficult
2) high risk for exercise: ventricular arrhythmia or hypotension during basical cardiopulmonary exercise test
3) chronic kidney disease stage 4= (eGFR <30 mL/min/1.73m2)
4) active infection
5) active cancer
6) long term treatment of immune-suppresive drugs or steroid
7) congestive heart failure class 4
8) genetic disorder such as familial hypercholesterolemia
9) life expectancy < 2 yr due to accompanied disease
10) pateints already participated in other RCT (randomized controlled trial) study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a composite of total death, sudden cardiac death, nonfatal MI, nonfatal stroke, revascularization [percutaneous coronary intervention, coronary artery bypass graft surgery], hospitalization due to cardiovascular cause, cardiac transplantation
- Secondary Outcome Measures
Name Time Method compliance, exercise capacity (VO2 max, 6 minute walking test), hospital admission, HRQoL, drug compliance, economical efficiency, diabetic complication