Stepping towards precision rehabilitation; Establishing potential benefits and safety of early cardiac rehabilitation in diabetics post acute coronary syndrome
Not Applicable
- Conditions
- Acute Coronary SyndromeCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12624000389505
- Lead Sponsor
- Baker Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
1. 18-80 years
2. Fluent in English
3. Fulfills Universal definition for Type I myocardial infarction within 2 weeks of enrolment
4. Diagnosed with Type II Diabetes
5. Ability to perform a bout of exercise on a treadmill or bike
6. Access to the Internet and Smart phone
Exclusion Criteria
1. > 80 years of age
2. Stage V Chronic Kidney Disease
3. Liver disease with documented cirrhosis
4. Severe pulmonary disease (FEV < 50%)
4. Type I Diabetes
5. History of sustained ventricular tachycardia with haemodynamic collapse or aborted sudden cardiac death.
6. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants who experience functional improvement at 6 months determined by change in exercise capacity[Cardiopulmonary exercise test (CPET) using stationary cycle and a standardized ramp test protocol and activity monitoring using accelerometer (ARTG actigraph). Baseline and 6 months post-randomization.]
- Secondary Outcome Measures
Name Time Method Change in self-reported quality of life metrics[HRQOL metrics via self-reported questionnaire via telehealth. Kansas City Cardiomyopathy Questionnaire, SF-36 questionnaire, (all questionnaires relate to quality-of-life self-assessment). This will be assessed as a composite outcome as a combination of each questionnaire. <br> Baseline, 3 months and 12 months post-randomization.];Cardiovascular mortality[Exercise will be performed using a cardiopulmonary exercise test on a treadmill. <br> Baseline and 6 months post-randomization.];Metabolic parameters [ HbA1c, fasting glucose, total cholesterol on blood test Baseline and 6 months post-randomization.];Visual analogue score assessing quality of life[Visual analogue scale with questions designed specifically for this study Baseline and 6 months post-randomization]