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Trial registered on ANZCTR


Registration number
ACTRN12609000645257
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
30/07/2009
Date last updated
3/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise to improve heart and brain health following stroke
Scientific title
Aerobic exercise to improve cardiovascular and neurological health outcomes in the chronic stroke population
Secondary ID [1] 284548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 237330 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239645 239645 0 0
Other physical medicine / rehabilitation
Stroke 239648 239648 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised to participate in aerobic exercise three times a week for 12 weeks or usual care. The exercise classes include stations of treadmill training, stationary cycling, arm and/or leg ergometry and weight bearing exercise such as steps and overground walking and last for 1 hour. Blinded assessment of outcome is performed at baseline, 3 and 6 months.
Intervention code [1] 236992 0
Rehabilitation
Comparator / control treatment
Usual care provided by patients' general practitioner and allied health professionals, excluding supervised aerobic exercise programmes for 12 weeks, the same duration as the exercise group.
Control group
Active

Outcomes
Primary outcome [1] 238428 0
Cognitive function using the following 4 tests, and combined to form a Z score: Trail making test B, the Free and Cued Selective Reminding test, Inspection time, and modified Paced Auditory Serial Addition Test.
Timepoint [1] 238428 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [1] 244915 0
Physical abilities using the following tests: the Timed Up and Go, the 6 Minute Walk Test, gait velocity and the Sit-to-Stand test
Timepoint [1] 244915 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [2] 244916 0
Cognitive function using the following tests: The Stroop test, Verbal fluency, Trail making tests A and B, The Grober and Buschke Free and Cued Selective Reminding test, digit span backwards and forwards, spatial span test, Inspection time and Paced Auditory Serial Addition Test.
Timepoint [2] 244916 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [3] 244917 0
Cerebral blood flow and vessel reactivity using transcranial doppler ultrasound
Timepoint [3] 244917 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [4] 244918 0
Quality of life assessment using the Assessment of Quality of Life tool (AQoL)
Timepoint [4] 244918 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [5] 244920 0
Cost effectiveness and cost utility using the AQoL to calculate quality adjusted life years (QALYs)
Timepoint [5] 244920 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [6] 244921 0
Response to stimulation of the motor cortex to induce plasticity using repetitive transcranial magnetic stimulation
Timepoint [6] 244921 0
At baseline, 3 and 6 months following randomisation
Secondary outcome [7] 339372 0
Peak oxygen uptake (VO2 peak) using a submaximal exercise test (the Physical Work Capacity test at 75% of age-predicted maximum heart rate) on a recumbent cycle and open-circuit spirometry
Timepoint [7] 339372 0
At baseline, post intervention (3/12) and then 6 months post intervention (9/12 after baseline)

Eligibility
Key inclusion criteria
Diagnosis of first or recurrent stroke, haemorrhage or infarct at least 6 months prior to entry into the study.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to participate in an exercise programme due to medical conditions such as heart failure, unstable angina, dementia and receptive aphasia. Patients on beta-blockers.
Patients already participating in a supervised aerobic exercise programme.
Patients who have epilepsy, metallic implants in the skull or cardiac pacemakers will be excluded from the transcranial magnetic stimulation.

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)
Allocation was performed by a person independent to the study and concealed in sealed opaque envelopes. After baseline testing, the research assistant not blinded to group allocation contacted this researcher and informed the participant of group allocation. The outcome assessor remained blinded to allocation until after the statistical analyses were completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated using software by researchers not involved with participants or data collection. There was no stratification. This was decided before the first participant was recruited
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2009
Actual
1/09/2009
Date of last participant enrolment
Anticipated
28/02/2017
Actual
5/12/2014
Date of last data collection
Anticipated
31/03/2017
Actual
12/06/2015
Sample size
Target
150
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 237379 0
Government body
Name [1] 237379 0
NHMRC Fellowship
Country [1] 237379 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 236878 0
Hospital
Name [1] 236878 0
Centre for Physical Activity in Ageing (Royal Adelaide Hospital)
Address [1] 236878 0
207-255 Hampstead Rd
Northfield SA 5085
Country [1] 236878 0
Australia
Other collaborator category [1] 787 0
University
Name [1] 787 0
The University of Adelaide
Address [1] 787 0
Neuromotor Plasticity & Development (NeuroPAD)
School of Paediatrics & Reproductive Health University of Adelaide Adelaide SA 5005 AUSTRALIA
Country [1] 787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239511 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 239511 0
University of South Australia
Research and Innovation Services
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [1] 239511 0
Australia
Date submitted for ethics approval [1] 239511 0
Approval date [1] 239511 0
21/07/2009
Ethics approval number [1] 239511 0
P090/09

Summary
Brief summary
Aerobic exercise can improve cardiovascular fitness, mobility and physical function following stroke but it is not known whether it has an effect on cognitive and neurological function. We intend to compare a 12 week exercise program with usual care to document changes in impairment, activity and participation, as well as performing a cost-effectiveness study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29945 0
Dr Michelle McDonnell
Address 29945 0
School of Health Sciences
University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 29945 0
Australia
Phone 29945 0
+61 88302 1684
Fax 29945 0
Email 29945 0
[email protected]
Contact person for public queries
Name 13192 0
Dr Michelle McDonnell
Address 13192 0
School of Health Sciences
University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 13192 0
Australia
Phone 13192 0
+61 8 8302 1684
Fax 13192 0
+61 8 8302 2168
Email 13192 0
[email protected]
Contact person for scientific queries
Name 4120 0
Dr Michelle McDonnell
Address 4120 0
School of Health Sciences
University of South Australia
GPO Box 2417
Adelaide SA 5001
Country 4120 0
Australia
Phone 4120 0
+61 8 8302 1684
Fax 4120 0
+61 8 8302 2168
Email 4120 0
[email protected]

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No Supporting Document Provided



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