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Stepping towards precision rehabilitation; Establishing potential benefits and safety of early cardiac rehabilitation in diabetics post acute coronary syndrome

Stepping towards precision rehabilitation; Establishing potential benefits and safety of early cardiac rehabilitation in diabetics post acute coronary syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000389505
Enrollment
3
Registered
2024-04-03
Start date
2024-07-25
Completion date
2026-01-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cardiovascular disease is the leading cause of death and disability among adults globally. In Australia it is the lead contributor to health care expenditure and with an ageing population the burden of disease is expected to increase. Cardiac rehab is an effective secondary prevention tool post acute coronary syndrome acute coronary syndrome but is underutilised and inconsistently delivered. The trial will whether early cardiac rehabilitation in high-risk acute coronary syndrome results in greater functional improvement at 6 months when compared to later and standard of care, examine the safety of cardiopulmonary testing to support exercise prescription, and define the metabolic profiles of post acute coronary syndrome.

Interventions

Immediate enrolment in cardiac rehab (12 weeks exercise-based program, Cardihab educational support, telehealth follow-up) 1-week post revascularization of acute myocardial infarction. - Accredited exercise physiologist will be supervising the exercise session. - Patient will attend individually or in group no more than 6. - Exercise prescription will be personalized based on the cardiopulmonary exercise testing and therefore will incorporate various level of exercise intensity (low, moderate

Immediate enrolment in cardiac rehab (12 weeks exercise-based program, Cardihab educational support, telehealth follow-up) 1-week post revascularization of acute myocardial infarction. - Accredited exercise physiologist will be supervising the exercise session. - Patient will attend individually or in group no more than 6. - Exercise prescription will be personalized based on the cardiopulmonary exercise testing and therefore will incorporate various level of exercise intensity (low, moderate and in some participants vigorous). Two supervised exercise sessions per week (each consisting of 30 minutes of aerobic training and 30 minutes of resistance training), one unsupervised 30–60 minute home-based aerobic exercise session per week. Each exercise program is individually prescribed based on the baseline maximal exercise test and regular submaximal incremental exercise tests performed throughout the intervention. This periodization plan follows a modified version of the 2:1 step paradigm (2 weeks of loading, 1 week unloading). - Educational session will be facilitating by a clinical research nurse through the CardiHab Platform (https://cardihab.com/). Standard educational materials will be used and selected based on intake history in order to optimize secondary prevention strategies, including diet, nutrition, and lifestyle factor modification. These are standard education materials from the CardiHab (TGA registered) platform, designed to meet TGA guidelines for secondary prevention of cardiac disease. - Telehealth follow up will be conducted by a research assistant and escalated to the clinical research nurse and or PI/Cardiology when appropriate. It will serve as a check-in, data collection, and advice provided as required. - follow up with occur 12 months following enrollment.

Sponsors

Baker Heart and Diabetes Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026