ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001586808

Ethics application status

Approved

Date submitted

18/10/2021

Date registered

19/11/2021

Date last updated

7/11/2022

Date data sharing statement initially provided

19/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

CRAMS trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

transient ischaemic attack

stroke

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

Lifestyle

Comparator / control treatment

Those randomised to the control group will participate in usual care following a TIA or mild-stroke. This typically consists of follow-up with a neurologist and little or no secondary prevention. Control participants will be wait-listed for the CVR program and will commence the CVR program 6-months after they have completed their baseline measures.

Control group

Active

Outcomes

Primary outcome [1]

Functional exercise capacity (6-minute walk test). The 6-minute walk test (6MWT) is a commonly used objective measure of functional exercise capacity in cardiac rehabilitation and stroke. The distance an individual is able to walk along a flat 25–30 m walkway over a 6-min period, with breaks as required, is recorded. The test is a self-paced, submaximal test of exercise capacity, and has been found to have a moderate-to-high reliability and validity. A change in distance of 34 m is considered a clinically meaningful change in people post stroke.

Timepoint [1]

Baseline (start of CVR program), 6-weeks (primary timepoint, end of CVR program) and 6-months (follow-up).

Secondary outcome [1]

Physical activity levels. A triaxial commercial accelerometer (ActiGraph GT3X, Fort Walton Beach, FL) will be used to objectively assess physical activity. Participants will be asked to wear the monitor on their right hip during a typical week while awake for 7-consecutive days. The raw data collected by the accelerometer, counts, will be used to obtain the time spent in different physical activity intensities.

Timepoint [1]