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Trial registered on ANZCTR


Registration number
ACTRN12616000942459
Ethics application status
Approved
Date submitted
30/06/2016
Date registered
15/07/2016
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise on brain volume and function after stroke
Scientific title
The effect of prescribed exercise intervention on brain volume and function after stroke
Secondary ID [1] 289575 0
None
Universal Trial Number (UTN)
Trial acronym
Post Ischaemic Stroke Cardiovascular Exercise Study (PISCES)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 299307 0
Dementia 299308 0
End-organ cerebrovascular disease 299309 0
Condition category
Condition code
Stroke 299300 299300 0 0
Ischaemic
Neurological 299301 299301 0 0
Dementias
Cardiovascular 299302 299302 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At recruitment, participants will be randomly allocated into one of two exercise groups using a computer generated schedule. At 2 month post-stroke, participants will undertake their respective exercise programmes. The exercise programme will occur 3 times per week for a duration of 8 weeks. Each exercise session will involve 1 hour of activities. The two exposure groups are:
* Balance-Stretching Group: Warm up (5 mins), Balance activities (25 mins), Stretching activities (25 mins), Cool down (5 mins).
* Strength Training-Aerobic Exercise Group: Warm up (5 mins), Strength activities (10 mins), Aerobic activities (i.e., activities that will raise heart-rate and breathing = 30 mins), Cool down (5 mins).

Exercise sessions will take place at a time and location convenient for participants. At each of these exercise sessions a qualified Exercise Physiologist or Physiotherapist associated with this study will be present to deliver the prescribed intervention and monitor adherence. The individual activities undertaken in each of the exercise programmes will vary depending on each participant’s fitness level and will be progressed over the 8 weeks to match any improvements made. The programmes have been established in accordance with an international framework for prescribing safe and efficacious exercise interventions to chronic stroke populations.

Participants will be aware of their group allocation based on the exercise programme they are administered. Investigators who are blind to participant group will conduct the pre- and post-exercise intervention assessments.

Participants will be asked to keep a daily activity diary that records participant
activity levels between assessment visits. Such diaries are common place as a part of
general post-stroke rehabilitation programmes and this is not expected to be an
inconvenience for participants.
Intervention code [1] 295182 0
Treatment: Other
Intervention code [2] 295241 0
Prevention
Intervention code [3] 295242 0
Lifestyle
Comparator / control treatment
A ‘Control’ group (i.e., No exercise) will not be directly sampled. This study has been designed to fit closely alongside the CANVAS trial timepoints (Trial ID: NCT02205424) so ‘Control’ information can be captured from the existing CANVAS database.
Control group
Active

Outcomes
Primary outcome [1] 298798 0
Impact of a prescribed 8-week aerobic exercise intervention at 2-months after ischaemic stroke on:

1. Whole brain volume and site-specific regional brain volume as measured via MRI brain scans.
Timepoint [1] 298798 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.
Primary outcome [2] 298928 0
Impact of a prescribed 8-week aerobic exercise intervention at 2-months after ischaemic stroke on:

2. Changes in neurocognitive function and mood state as measured by a neuropsychological assessment battery.
Timepoint [2] 298928 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.
Primary outcome [3] 298929 0
Impact of a prescribed 8-week aerobic exercise intervention at 2-months after ischaemic stroke on:

3. The change in BDNF and HbA1c levels as measured by blood pathology analysis.
Timepoint [3] 298929 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.
Secondary outcome [1] 325237 0
Impact of a prescribed 8-week aerobic exercise intervention at 2-months after ischaemic stroke on:

4. Changes in vascular burden using 3 end-organ effects:
4a) incident recurrent brain infarction (measured via clinical report and MRI),
4b) cardiac diastolic dysfunction,
4c) ambulatory blood pressure.

4b and 4c will be measured using a 24 hour ambulatory blood pressure and ECG recorder.
Timepoint [1] 325237 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.
Secondary outcome [2] 325667 0
A sub-study nested within the greater protocol, will help understand the specific factors that influence participation in, or adherence to, post-stroke exercise regimens.

This will be assessed using a qualitative semi-structured interview.
Timepoint [2] 325667 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.

Eligibility
Key inclusion criteria
- Ischaemic stroke (first stroke);
- Able to attend 3 study sessions over 10 months;
- Motivation and willingness to participate in the study protocol;
- No prior neurological or psychiatric disease, including stroke or dementia;
- Can give informed consent and participate in cognitive testing.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No significant medical comorbidities (e.g., severe cardiac disease) and/or musculoskeletal injuries precluding participation in exercise intervention, or making survival for 1 year poststroke unlikely;
- Regular exclusion criteria for MRI (e.g., implanted metal, severe claustrophobia);
- Pre-existing dementia, or mRS >3.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At recruitment, participants will be randomly allocated into one of two exercise groups using a computer generated schedule with permuted blocks of various sizes. This will be part of the electronic case report form (ECRF) hosted at secure server at the Florey and compliant with Good Clinical Practice (GCP) guidelines for clinical trials. The randomisation will be stratified by baseline function (modified Rankin Scale score, grouped into mRS 0-1, 2 and 3).
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
While investigators conducting the exercise programme will be aware of participant group in order to prescribe and deliver the exercise intervention, only investigators who are blind to participant group will conduct cognitive/mood testing, MRI analysis, and cardiovascular testing.

All data will be analysed in a de-identified format.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
VIC
Recruitment hospital [1] 6054 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 6055 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 13503 0
3084 - Heidelberg
Recruitment postcode(s) [2] 13504 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 293968 0
Charities/Societies/Foundations
Name [1] 293968 0
Heart Foundation
Address [1] 293968 0
12/500 Collins St
Melbourne
VIC
3000
Country [1] 293968 0
Australia
Primary sponsor type
Other
Name
The Florey Institute of Neuroscience and Mental Health
Address
Melbourne Brain Centre
Austin Campus
245 Burgundy Street
Heidelberg
VIC
3084
Country
Australia
Secondary sponsor category [1] 292782 0
None
Name [1] 292782 0
Address [1] 292782 0
Country [1] 292782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295383 0
Austin Health HREC
Ethics committee address [1] 295383 0
Level 8 Harold Stokes Building
Austin Health
145 Studley Road
Heidelberg
VIC 3084
Ethics committee country [1] 295383 0
Australia
Date submitted for ethics approval [1] 295383 0
31/03/2016
Approval date [1] 295383 0
26/05/2016
Ethics approval number [1] 295383 0
HREC/16/Austin/45

Summary
Brief summary
There is a link between two major causes of death, disability, and reduced quality of life in our society: stroke and neurodegenerative dementia. We now understand patients who suffer stroke are more likely to experience a long-term decline in thinking ability and a reduction in brain volume. Exercise is a simple, yet effective, method of improving cardiovascular health. We will examine if exercise after stroke can modify risk factors that may lead to post-stroke brain atrophy and cognitive decline.

The aim of this project is to determine whether aerobic exercise has a positive impact on preserving brain volume and function, as well as general physical and psychological well-being. We hypothesise that participants who undertake prescribed aerobic exercise (i.e., exercise that increases heart rate and breathing) after a stroke will have preserved brain volume and neurocognitive performance, higher mood levels, and better end-organ disease well-being (i.e., less recurrent strokes, improved blood pressure, reduced cardiovascular disease) compared to participants who do not undertake aerobic exercise.

Results from this study will provide unique information on the relationship between stroke, physical activity, brain health, and dementia. Our findings will establish whether post-stroke aerobic physical activity can prevent, or at least minimise, the impact of brain atrophy, cognitive impairment, and end organ disease state. A prescribed and tailored exercise programme could offer a simple and economically viable solution to patient care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67046 0
A/Prof Amy Brodtmann
Address 67046 0
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre
Austin Campus
245 Burgundy Street
Heidelberg VIC
3084
Country 67046 0
Australia
Phone 67046 0
+61 3 9035 7004
Fax 67046 0
Email 67046 0
agbrod@unimelb.edu.au
Contact person for public queries
Name 67047 0
Dr Emilio Werden
Address 67047 0
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre
Austin Campus
245 Burgundy Street
Heidelberg VIC
3084
Country 67047 0
Australia
Phone 67047 0
+61 3 9035 7275
Fax 67047 0
Email 67047 0
ewerden@florey.edu.au
Contact person for scientific queries
Name 67048 0
A/Prof Amy Brodtmann
Address 67048 0
The Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre
Austin Campus
245 Burgundy Street
Heidelberg VIC
3084
Country 67048 0
Australia
Phone 67048 0
+61 3 9035 7004
Fax 67048 0
Email 67048 0
agbrod@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results