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Trial registered on ANZCTR


Registration number
ACTRN12618001873213p
Ethics application status
Submitted, not yet approved
Date submitted
7/11/2018
Date registered
16/11/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CArdiac REhabilitation for the Secondary prevention of Stroke (CARESS)
Scientific title
Effect of cardiac rehabilitation on cardiovascular risk factors and health-related quality of life in stroke survivors: CArdiac REhabilitation for the Secondary prevention of Stroke (CARESS)
Secondary ID [1] 296414 0
None
Universal Trial Number (UTN)
U1111-1222-7596
Trial acronym
CARESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 310327 0
Condition category
Condition code
Stroke 309059 309059 0 0
Ischaemic
Stroke 309115 309115 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 7 week program for 2 hours per week including 1 hour of education and 1 hour of exercise in a group setting. The program will be delivered in a group setting face to face at a clinical research facility. The program will be delivered by an experienced aged-care nurse, physiotherapist with expertise in stroke and exercise physiologist.
The nurse will facilitate the 1 hour group-based education component of the program. Materials for the group discussion will be based on those developed by the Stroke Foundation. There will be 7 topics including: (1) life after stroke, (2) risk factors for stroke, (3) medications, (4) mental health, (5) getting back to everyday activities, (6) relationships after stroke, and (7) memory and thinking.
The exercise component will be led by a physiotherapise and an exercise physiologist. Each exercise session will comprise a 15 minute warm up followed by a 30 minute low to moderate intensity exercise circuit with at 15 minute cool down. The circuit will comprise different exercise modalities, both aerobic and resistance in nature that target different parts of the body. All exercises will be able to be completed standing or seated to allow for different levels of function of participants. There will be exercises with optional weight components to increase the intensity, if appropriate. The program will align with international recommendations on the best practice for exercise programs after stroke.
Each participant will be prescribed the intensity of exercise appropriate for their fitness and health before the program. The intensity of all exercise completed in the circuit will be monitored closely using a combination of heart rate data (obtained from participant worn heart rate monitors) and self-reported exertion using the Borg Rating of Perceived Exertion scale. Exercise intensity will be increased if the participant is not meeting the prescribed intensity or will be ceased or adjusted if the participant is exceeding the pre-specified intensity range.
Adherence to the program will be monitored through marking attendance at each education and exercise session by the study nurse/exercise physiologist/physiotherapist. In addition, participant satisfaction with the program will be assessed at the completion of the program with the Physical Activity Enjoyment Scale, 3 questions on program satisfaction recommended by the Consumer Assessment of Health Care Providers and Systems and 3 questions regarding the participant's opinion of the program impact.
Intervention code [1] 312851 0
Lifestyle
Intervention code [2] 312899 0
Rehabilitation
Comparator / control treatment
This pilot study is using a pre/post comparison of outcomes without a control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308023 0
The primary outcome in the change in health-related quality of life with the Assessment of Quality of Life for people with stroke in the program.
Timepoint [1] 308023 0
The primary timepoint is from the 6 week assessment after the program has concluded. The primary outcome is the change in health-related quality of life from the pre-program assessment to 6 weeks after the program has concluded.
Primary outcome [2] 308024 0
The second primary outcome is the change in systolic and diastolic blood pressures (mmHg) measured with an automatic blood pressure monitor for people with stroke in the program from the pre-program assessment to 6 weeks after the program has concluded..
Timepoint [2] 308024 0
The second primary outcome timepoint is from the 6 week assessment after the program has concluded. The second primary outcome is the change in systolic and diastolic blood pressure from the pre-program assessment to 6 weeks after the program has concluded.
Primary outcome [3] 308025 0
The third primary outcome is the change in the knowledge of stroke risk factors and warning signs examined with the Stroke Assessment Questionnaire. This 9 item questionnaire was developed in Ireland by Hickey and colleagues and examines knowledge of stroke risk factors and warning signs.
Timepoint [3] 308025 0
The timepoint for the third primary outcome is the change in the proportion of people correctly identifying what a stroke is, risk factors for stroke, symptoms/signs of a stroke, appropriate action after having a stroke, and treatments for stroke from the pre-program assessment to 6 weeks after the conclusion of the program.
Secondary outcome [1] 353677 0
Change in fatigue in people with stroke measured with the Fatigue Assessment Scale
Timepoint [1] 353677 0
The secondary timepoint will examine change in fatigue score from the pre-program assessment to 1 week after the program has concluded. This 1 week time point has been chosen to capture the potential proximal effects of the exercise program on fatigue in participants.
Secondary outcome [2] 353678 0
Change in physical activity measured using the International Physical Activity Questionnaire in people with stroke.
Timepoint [2] 353678 0
The conclusion timepoint will examine the change in total and leisure time physical activity in minutes per week between the pre-program assessment and the 6 week assessment after the program has concluded.
Secondary outcome [3] 353679 0
Change in psychological wellbeing in people with stroke measured with the total score on the Patient Health Questionnaire
Timepoint [3] 353679 0
We will examine changes in the total score from the Patient Health Questionnaire between the pre-program assessment and the 6 week assessment after the conlcusion of the program.
Secondary outcome [4] 353680 0
Change in cardiorespiratory fitness measured with the 6 minute walk test in people with stroke.
Timepoint [4] 353680 0
We will examine the change in the distance walked during the 6 minute walk test from the pre-program assessment to the 6 week assessment after the program has concluded.
Secondary outcome [5] 353808 0
Health-related quality of life among support people attending the program using the Assessment of Quality of Life instrument
Timepoint [5] 353808 0
We will examine change in the score from Assessment of Quality of Life instrument from the pre-program assessment to the 6 week assessment for support people that participate in the program.
Secondary outcome [6] 353809 0
Change in knowledge of stroke risk factors and signs among support people that participate in the program with the Stroke Awareness Questionnaire.
Timepoint [6] 353809 0
We will examine change in the proportion of suppor people correctly identifying what a stroke is, the risk factors for stroke, symptoms of stroke, action to take when a person has a stroke and treatments for stroke from the pre-program assessment to the 6 week assessment.

Eligibility
Key inclusion criteria
The inclusion criteria for people with stroke are:
1. The person has suffered a stroke and been treated at the Royal Hobart Hospital
2. The person has been discharged either from (a) acute care to home or (b) from rehabiliation to home.
The inclusion criteria for support people is:
1. The person is a carer or support person for a participant in the program
2. The support person consents to participate in the education component of the program

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for people with stroke in the study are:
1. Moderate or severe dementia (Telephone Interview for Cognitive Status–Modified scores lower than 19 of 50)
2. Medically unstable and unable to participate in either seated or standing light to moderate physical activity, as determined by medical professionals
The exclusion criteria for support people in the program is:
1. Moderate or severe dementia (Telephone Interview for Cognitive Status–Modified scores lower than 19 of 50)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed in this pilot study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We will report the recruitment details included numbers screened, excluded, beginning and finishing the program. We will record the number of support people that participate in the program. Descriptive statistics will be used to summarise the participant’s baseline characteristics, physical function, HRQoL, fatigue, depression symptoms, behaviour risk factors and cardiovascular risk factors at baseline and post intervention. For support people, we will examine HRQoL and stroke awareness and knowledge before and after the program. The number and type of adverse events and number of participants that withdrew from the study will be reported. Participant satisfaction was summarised using descriptive statistics for each questionnaire scale. To determine an estimate of the magnitude of effect between pre and post intervention for each outcome, 95% confidence intervals will be calculated as per the CONSORT statement for pilot and feasibility studies. Analyses were performed using STATA v15 (StataCorp, College station, Texas).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 12372 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 24635 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 301021 0
Charities/Societies/Foundations
Name [1] 301021 0
Royal Hobart Hospital Research Foundation
Address [1] 301021 0
Ground floor, 22 Elizabeth Street, Hobart TAS 7000
Country [1] 301021 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave, Sandy Bay, Tasmania, 7005
Country
Australia
Secondary sponsor category [1] 300745 0
None
Name [1] 300745 0
Address [1] 300745 0
Country [1] 300745 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301776 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 301776 0
Churchill Ave, Sandy Bay, Tasmania, 7005
Ethics committee country [1] 301776 0
Australia
Date submitted for ethics approval [1] 301776 0
17/10/2018
Approval date [1] 301776 0
Ethics approval number [1] 301776 0

Summary
Brief summary
Our research has identified that many stroke survivors have poorly managed risk factors after stroke and many report ‘unmet needs’. To address these issues, we hypothesise that a cardiac rehabilitation program adapted for stroke survivors can improve secondary prevention of cardiovascular disease. Cardiac rehabilitation programs include exercise to increase cardiorespiratory fitness and educate people on ways to manage their health to prevent further cardiac events. These programs are known to reduce recurrent cardiac events in a cost-effective way.
The specific aim is to run a pilot study of an adapted cardiac rehabilitation program in a group of stroke patients to examine its feasibility, acceptability and effect on cardiovascular risk factors and health-related quality of life.
The program to be piloted takes into account the feedback from this broad range of stakeholders. The co-designed program will run for 7 weeks. It will include 1 hour of group exercise that can be adapted to suit different levels of function using a combination of standing and seated exercises with addition of light resistance, if appropriate. Following the exercise training, group-based discussion around a variety of topics will be led by a nurse facilitator with expert input into the content from physiotherapists, exercise physiologists, nutritionists and pharmacists. The exercise program will be designed and monitored by exercise physiologists and physiotherapists. The program will leverage off existing resources developed by the Stroke Foundation for stroke survivors and link into their existing online support systems to increase the maintenance of the program for participants.
We will run 2 groups of 5 people per group in the first half of 2019. The study includes baseline assessment, program delivery for 2 hours per week for 7 weeks, a 1 week follow-up assessment and a 6 week follow-up assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88066 0
Dr Seana Gall
Address 88066 0
Menzies Institute for Medical Research, University of Tasmania, MSP, 17 Liverpool St, Hobart, Tasmania, 7000
Country 88066 0
Australia
Phone 88066 0
+61 362264728
Fax 88066 0
Email 88066 0
seana.gall@utas.edu.au
Contact person for public queries
Name 88067 0
Dr Seana Gall
Address 88067 0
Menzies Institute for Medical Research, University of Tasmania, MSP, 17 Liverpool St, Hobart, Tasmania, 7000
Country 88067 0
Australia
Phone 88067 0
+61 362264728
Fax 88067 0
Email 88067 0
seana.gall@utas.edu.au
Contact person for scientific queries
Name 88068 0
Dr Seana Gall
Address 88068 0
Menzies Institute for Medical Research, University of Tasmania, MSP, 17 Liverpool St, Hobart, Tasmania, 7000
Country 88068 0
Australia
Phone 88068 0
+61 362264728
Fax 88068 0
Email 88068 0
seana.gall@utas.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
The pilot study will include a small number of people. Sharing individual level data may compromise their privacy.
What supporting documents are/will be available?
No other documents available
Summary results
No Results