Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000389505
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepping towards precision rehabilitation; Establishing potential benefits and safety of early cardiac rehabilitation in diabetics post acute coronary syndrome
Scientific title
Stepping towards precision rehabilitation; Establishing potential benefits and safety of early cardiac rehabilitation in diabetics post acute coronary syndrome.
Secondary ID [1] 311411 0
Nil known
Universal Trial Number (UTN)
U1111-1303-2967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 332692 0
Condition category
Condition code
Cardiovascular 329402 329402 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327849 0
Rehabilitation
Comparator / control treatment
Standard of care - cardiac rehab. All interventions the same but intervention/rehab timeline as per standard care. The control group will receive the same program but at a delayed time. It usually takes 1-2 months to enrol in cardiac rehabilitation depending on the program, our study's comparator is specific enrolment one week after having an acute cardiac event versus the usual enrolment process (which is variable between programs, usually depending on demand).
Control group
Active

Outcomes
Primary outcome [1] 337220 0
Proportion of participants who experience functional improvement at 6 months determined by change in exercise capacity
Timepoint [1] 337220 0
Baseline and 6 months post-randomization.
Secondary outcome [1] 431104 0
Change in self-reported quality of life metrics
Timepoint [1] 431104 0
Baseline, 3 months and 12 months post-randomization.
Secondary outcome [2] 431105 0
Cardiovascular mortality
Timepoint [2] 431105 0
Baseline and 6 months post-randomization.
Secondary outcome [3] 432880 0
Metabolic parameters
Timepoint [3] 432880 0
Baseline and 6 months post-randomization.
Secondary outcome [4] 433375 0
Visual analogue score assessing quality of life
Timepoint [4] 433375 0
Baseline and 6 months post-randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization stratified by sex (male or female), with a 1:1 allocation via a computer-generated random number generator.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
27/01/2025
Actual
Date of last data collection
Anticipated
26/01/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315673 0
Charities/Societies/Foundations
Name [1] 315673 0
National Heart Foundation of Australia
Country [1] 315673 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 317776 0
None
Name [1] 317776 0
Address [1] 317776 0
Country [1] 317776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314551 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314551 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314551 0
Australia
Date submitted for ethics approval [1] 314551 0
24/08/2023
Approval date [1] 314551 0
17/10/2023
Ethics approval number [1] 314551 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131986 0
Dr Kegan Moneghetti
Address 131986 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 131986 0
Australia
Phone 131986 0
+61 03 8532 1866
Fax 131986 0
Email 131986 0
kegan.moneghetti@baker.edu.au
Contact person for public queries
Name 131987 0
Eloise Thompson
Address 131987 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 131987 0
Australia
Phone 131987 0
+61 03 8532 1862
Fax 131987 0
Email 131987 0
eloise.thompson@baker.edu.au
Contact person for scientific queries
Name 131988 0
Eloise Thompson
Address 131988 0
Baker Heart and Diabetes Institute, 75 Commercial Road, Melbourne VIC 3004
Country 131988 0
Australia
Phone 131988 0
+61 03 8532 1862
Fax 131988 0
Email 131988 0
eloise.thompson@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.