Skip to content

Cardiac Rehabilitation for transient ischaemic Attack and Mild-Stroke: the CRAMS randomised controlled trial.

Is an integrated traditional exercise-based cardiac rehabilitation program effective in improving functional exercise capacity for people with TIA or mild-stroke during the 6-months following commencement of the traditional cardiac rehabilitation program compared to usual care?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001586808
Acronym
CRAMS trial
Enrollment
140
Registered
2021-11-19
Start date
2022-04-08
Completion date
2024-03-22
Last updated
2025-12-01

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

Conditions

None listed

Brief summary

One in three strokes in Australia are repeat events. These repeat strokes are more likely to result in death and are costly, for both individuals and the healthcare system. Cardiac rehabilitation is a well-established and widely available secondary prevention program that reduces disease risk and death from heart disease and could help prevent repeat strokes as both share similar risk factors, such as physical inactivity, high blood pressure and poor diet. However, our research has found that less than 2% of Australian cardiac rehabilitation programs include people with stroke. This is despite Australian stroke health professionals and cardiac rehabilitation coordinators agreeing that cardiac rehabilitation is suitable for people after a transient ischaemic attack (TIA) or mild-stroke. Here the University of Canberra (UC) will partner with Canberra Health Services and Calvary Public Hospital, supported by the Stroke Foundation and Heart Foundation, to investigate the effectiveness of a 6-week integrated (TIA, mild-stroke, heart disease) traditional cardiac rehabilitation program (Cardiovascular rehabilitation) at the UC Health Clinics. Together we will recruit 140 Canberrans who have had a TIA or mild stroke over 2-years. These study participants will be randomly allocated to the Cardiovascular Rehabilitation program or a 6-month wait list group. We will then measure physical fitness, hospital admissions, blood pressure and other risk factors for stroke to determine the effectiveness of the program, as well as costs. Feedback from participants and health professionals will also be sought to guide the implementation of this novel program in other health services. Results will be disseminated to health professionals and the public via presentations, webinars and publications. If successful, the results will guide future research, policy and practice, potentially reducing the risk of repeat strokes locally, nationally and internationally. By reducing the risk of further strokes through the use of this existing secondary prevention program, we aim to help more Canberrans live longer after TIA and mild-stroke and avoid hospital readmissions.

Interventions

Cardiovascular Rehabilitation (CVR) program The CVR program included in this study is typical of most contemporary phase II cardiac rehabilitation programs in Australia. The cardiac rehabilitation program is multidisciplinary, time-limited (once a week, 6-weeks), conducted in groups, health service-based, and has educational and supervised exercise components (one hour education plus one hour exercise). Members of the multidisciplinary team include exercise physiologists, physiotherapists, dieti

Cardiovascular Rehabilitation (CVR) program The CVR program included in this study is typical of most contemporary phase II cardiac rehabilitation programs in Australia. The cardiac rehabilitation program is multidisciplinary, time-limited (once a week, 6-weeks), conducted in groups, health service-based, and has educational and supervised exercise components (one hour education plus one hour exercise). Members of the multidisciplinary team include exercise physiologists, physiotherapists, dietitians, psychologists, pharmacists and supervised university health students. The main aim of the exercise sessions will be to increase cardiovascular fitness or exercise capacity by exercising large muscle groups. The best predictor of an increased risk of death from any cause in men with cardiovascular disease is exercise capacity. For every 1-MET increase in exercise, there is a 9% improvement in survival. The exercise sessions will be conducted in the same way as a typical cardiac rehabilitation program as many cardiac rehabilitation participants have co-morbidities, including stroke. All exercise sessions will be individually tailored for each of the participants and supervised by a physiotherapist and/or exercise physiologist. Participants will be encouraged to exercise at a moderate intensity as recommended in cardiac rehabilitation guidelines. This will be monitored and measured using the modified Borg Rate of Perceived Exertion (RPE) scale, encouraging participants to exercise at an RPE of 4-6. The 'talk test' will also be used to monitor intensity of exercise, encouraging participants to exercise at a level where they can talk in full sentences but they cannot sing. Examples of the types of exercises they will be completing in the exercise class are walking on a treadmill, cycling on a stationary bike, stepping up and down on a set of steps, where appropriate. Members of the multi-disciplinary team will conduct group education sessions to increase the participant’s knowledge of their cardiovascular disease (CVD) condition and increase self-management skills for risk factor management. The education will be slightly modified compared to a typical cardiac rehabilitation program to include the anatomy and physiology of the brain, transient ischaemic attack (TIA) and ischemic stroke, and the management of stroke risk factors. The education sessions will cover: cardiac and brain anatomy and physiology; cardiac and stroke risk factors, modification and management of symptoms; how to deal with stress, anxiety and depression; cardiac and stroke medications; benefits of exercise and physical activity; and nutrition advice. The mode of delivery of these education sessions will be at the discretion of the health professional delivering each session. For example, they may involve multimedia presentations, informal group discussions and interactive activities. A CVR program attendance list will be maintained to record participants adherence to the 6 session program, including both the exercise and education session, which will be run in succession over a 2-hour period one day a week. People with heart disease will be recruited to this program to replicate a standard phase II cardiac rehabilitation program currently offered in Australia and to enable the integration of people with TIA, mild-stroke and heart disease in the same program. People with heart disease can be referred by cardiac rehabilitation health professionals, Cardiologists, General Practitioners or they can self-refer. All people with heart disease attending the program will complete initial and 6-week assessments and will take part in all exercise and education sessions. Although research outcomes will not be collected or analysed for this group as the evidence base for exercise-based cardiac rehabilitation for people with heart disease is well established.

Sponsors

A/Prof Nicole Freene
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

Eligible participants must: • be 18+ years old; • have a documented transient ischaemic attack (TIA) or mild non-disabling ischaemic stroke within the previous 12 months (National Institutes of Health Stroke Scale (NIHSS) score 0-4); • reside in the Australian Capital Territory.

Exclusion criteria

Participants will be excluded if they have: • evidence of intracranial haemorrhage on a CT or MRI study • undergone recent (<30 days) carotid endarterectomy • evidence of disabling stroke as measured by modified Rankin Scale score of greater than or equal to 3 • New York Heart Association class II-IV symptoms of heart failure • uncontrolled arrhythmias • severe chronic obstructive pulmonary disease • uncontrolled hypertension • symptomatic peripheral artery disease • unstable angina • uncontrolled diabetes • do not have adequate English language skills, including significant speech impairment, or cognitive skills to agree to take part om the study or participate in a group exercise program (may be guided by formal testing of cognition such as the MMSE) • previously completed cardiac rehabilitation.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 8, 2026