Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000229178
Ethics application status
Approved
Date submitted
31/01/2019
Date registered
18/02/2019
Date last updated
21/08/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
CardiacRehabPlus: Innovation to improve outcomes for TIA and cardiac rehabilitation patients
Scientific title
Is the CardiacRehabPlus model feasible for transient ischaemic attack/minor stroke and cardiac rehabilitation patients in addressing balance and gait deficits?
Secondary ID [1] 297043 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 311032 0
Transient Ischaemic Attack (TIA) 311033 0
Cardiovascular disease 311034 0
Condition category
Condition code
Stroke 309675 309675 0 0
Ischaemic
Stroke 309676 309676 0 0
Haemorrhagic
Cardiovascular 309677 309677 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive the standard 8 week cardiac rehabilitation program of physical activity and education delivered by cardiac rehab staff. Each weekly session consists of 30 minutes strength exercise, such as bicep curls or squats, and 30 minutes aerobic exercise, such as walking on a treadmill or riding an exercise bike. Intensity is monitored using the Borg RPE scale targeting a range of 12-14. Standard education modules include cardiac risk factor modification, stress management and mindfulness, medications and management, importance of physical exercise, blood sugar levels, healthy eating and food label reading. To encourage compliance participants receive a phone call should they not attend two sessions in a row. Graduation from the program only occurs once a participant attends eight sessions. The Plus component of the CardiacRehabPlus (CR+) program will comprise of additional balance and gait assessment performed by research staff for Transient Ischaemic Attack/minor stroke (TIA/mS) and cardiac cohorts at baseline and on completion of the program.
For the TIA/minor stroke cohort, CR+ will also be additional education modules tailored to the TIA/mS cohort. Balance and agility exercises will be included in the program. The additional balance and agility exercise will be provided by research physiotherapists and will be based on the OtagoPlus program, which has been shown to be effective in improving mild balance/gait dysfunction. Between group sessions, participants will be encouraged to do a home exercise program five days per week (approximately 20–30 min each time).
For the cardiac event cohort who consent be involved in the provision of balance and gait exercises, will receive in addition to the standard 8 week cardiac rehabilitation, an extra session per week for 8 weeks in parallel with the standard cardiac rehabilitation. The extra balance and agility exercise program will be 60 mins consisting of 30-40 mins of exercise with opportunities for rests – 5 min warm up, 30 minutes balance, agility and strength, 5 min cool down) with a maximum of 4 participants per session. Between group sessions, participants will be encouraged to do a home exercise program three days per week (approximately 20–30 min each time).

For both cohorts, exercises will be selected by the intervention physiotherapist from the kits of the exercises from the Otago Exercise Program and/or the Visual Health Information—Health Promotion Resources Balance and Vestibular exercise kit. Examples of the exercises included tandem walks, tandem stances, figure 8 walking, backwards walking. Exercises will be prescribed based on assessment findings and clinical judgement so participants perform at moderate intensity that challenged participants' balance. Participants will be provided with an exercise diary and these will be checked weekly to assist adherence to the home program.
Intervention code [1] 313321 0
Rehabilitation
Intervention code [2] 313569 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318644 0
Feasibility - number of patients in both cohorts completing the 8 week CR+ program - recorded on a session attendance record
Timepoint [1] 318644 0
within one week of completion of CardiacRahabPlus program
Primary outcome [2] 318645 0
Feasibility - time required to undertake balance, gait and agility assessment - recorded on a time sheet by research staff
Timepoint [2] 318645 0
within one week of completion of CardiacRahabPlus program
Primary outcome [3] 318956 0
Acceptability - of participants in being involved in cardiac rehabilitation program - assessed by survey of participants completing cardiac rehabilitation program
Timepoint [3] 318956 0
within one week of completion of CardiacRahabPlus program
Secondary outcome [1] 365578 0
Composite measure - Change in measures of balance (Step test and functional reach test) following cardiac rehabilitation program
Timepoint [1] 365578 0
within one week of completion of CardiacRahabPlus program
Secondary outcome [2] 366295 0
Composite measure. Change in measures of balance and gait (step test, functional reach, timed up and go) following the CardiacRehabPlus program
Timepoint [2] 366295 0
within one week of completion of the cardiac rehabilitation program

Eligibility
Key inclusion criteria
For both cohorts:
Aged 18 and over
• Living in the community (home, independent living unit, retirement village)
• Able to communicate in English
• Able to provide informed consent

For TIA/minor stroke cohort
• Diagnosis of TIA or minor stroke confirmed by a neurologist (determined clinically through questioning of participant or medical records) with a Modified Rankin Scale (mRS) less than or equal to 1 within the previous 12 weeks
• Prior to TIA or minor stroke able to ambulate independently outdoors with/without a gait aid
• Able to attend St Vincent’s Hospital Melbourne, Fitzroy campus
• Having medical clearance to undertake an exercise program

For cardiac cohort:
• Diagnosis of a cardiac condition
• Referred to and commenced participation in the SVHM cardiac rehabilitation program
• Prior to cardiac event, able to ambulate independently outdoors with/without a gait aid
• Attending the SVHM, Fitzroy campus cardiac rehabilitation program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have any other neurological conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
Date of last participant enrolment
Anticipated
13/01/2020
Actual
Date of last data collection
Anticipated
9/03/2020
Actual
Sample size
Target
35
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12864 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 12865 0
St Vincent's Private Hospital - Kew
Recruitment postcode(s) [1] 25340 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301612 0
Charities/Societies/Foundations
Name [1] 301612 0
Vanguard Heart Foundation
Country [1] 301612 0
Australia
Funding source category [2] 301613 0
Hospital
Name [2] 301613 0
St Vincent's Hospital, Melbourne
Country [2] 301613 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
34-45 Poplar Road
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 301315 0
None
Name [1] 301315 0
Address [1] 301315 0
Country [1] 301315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302339 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 302339 0
St Vincent's Hospital, Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 302339 0
Australia
Date submitted for ethics approval [1] 302339 0
06/03/2019
Approval date [1] 302339 0
19/06/2019
Ethics approval number [1] 302339 0

Summary
Brief summary
Transient ischemic attack and minor stroke (TIA/mS) are common cerebrovascular events affecting tens of thousands of Australians. People with TIA/mS usually receive minimal, if any, rehabilitation despite high risk of further stroke, and in many, mild balance and gait problems. Also, people who have had a cardiac event are offered cardiac rehabilitation but do not necessarily have their balance assessed. This project addresses these two substantial gaps. People with TIA/mS will receive rehabilitation through existing cardiac rehabilitation services and the people with cardiac conditions who are participating in cardiac rehabilitation programs will be assessed for balance and gait dysfunction. If deficits are identified, balance and agility exercises will be provided.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89878 0
Dr Frances Batchelor
Address 89878 0
National Ageing Research Institute
34-45 Poplar Road
Parkville Vic 3050
Country 89878 0
Australia
Phone 89878 0
+61 3 8387 2383
Fax 89878 0
Email 89878 0
[email protected]
Contact person for public queries
Name 89879 0
Ms Sue Williams
Address 89879 0
National Ageing Research Institute
34-45 Poplar Road
Parkville Vic 3050
Country 89879 0
Australia
Phone 89879 0
+61 3 83872614
Fax 89879 0
Email 89879 0
[email protected]
Contact person for scientific queries
Name 89880 0
Dr Frances Batchelor
Address 89880 0
National Ageing Research Institute
34-45 Poplar Road
Parkville Vic 3050
Country 89880 0
Australia
Phone 89880 0
+61 3 8387 2383
Fax 89880 0
Email 89880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is a pilot study.


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.