Trial Review

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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
23/05/2024
Date data sharing statement initially provided
2/02/2022
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, home-based, cardiorespiratory fitness training 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 - Zoom Delivered Intervention Against Cognitive Decline (PISCES-ZODIAC)
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
Participants are randomly allocated into one of two fitness training intervention groups using a computer-generated schedule. At 2-month post-stroke, participants undertake their respective fitness training programs. The fitness training program occurs 3 times per week for a duration of 8 weeks. Each fitness training session involves 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).

The trial commenced on 26/05/2016 with exercise sessions being delivered face-to-face by an Exercise Physiologist or Physiotherapist (EP) at a time and location convenient for participants. 34 participants were recruited. Due to restrictions and health guidance enacted during the global pandemic, on 27/10/20 the sessions were pivoted to be delivered live, one-on-one by an EP via the video-conferencing platform Zoom from within the participants’ own homes.

The EP closely monitors participants to ensure they are safe to exercise. For safety purposes, and to support intervention fidelity, participants are trained in conducting their own safe-to-exercise measures. Heart Rate and Rate of Perceived Exertion are self-monitored by the participant and reported back to the EP in real time for recording during each exercise session.

The individual activities undertaken in each of the fitness training 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 fitness training programme they are administered. Investigators who are blind to participant group will conduct the pre- and post-fitness training intervention assessments.

To gauge activity levels outside of the intervention during the fitness training programs, all participants will be assessed via the Physical Activity Scale for the Elderly questionnaire at the start of each week of the intervention.

As reflected in the changes to the study title, the study now includes two independent components of the intervention delivery: face-to-face and telehealth. These components will be analysed and reported independently, with a potential pooling of the results through meta-analysis if appropriate.
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 cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 1. Whole brain volume and site-specific regional brain volume as measured via change in MRI brain scans.
Timepoint [1] 298798 0
4-months post-stroke
Secondary outcome [1] 325237 0
Impact of a prescribed 8-week cardiorespiratory fitness training 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.
Secondary outcome [3] 405799 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 3. levels of biomarkers as measured by blood pathology analysis: BDNF, HbA1c, IL-6, IL-1ß, TNF-a, IL-8, IL-10, and IL-1ra
Timepoint [3] 405799 0
4-months and 12-months post-stroke
Secondary outcome [4] 405800 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 4. levels of general fitness as measured by VO2 peak graded exercise test using a total body recumbent stepper
Timepoint [4] 405800 0
2 months post-stroke (Baseline), 4 months post-stroke, and 12 months post-stroke.
Secondary outcome [5] 405801 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 5. daily physical activity, energy expenditure and objective sleep activity as measured by the Actiwatch Spectrum Plus
Timepoint [5] 405801 0
4-months and 12-months post-stroke
Secondary outcome [6] 405802 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 6. diet. Participants complete a 3-day food diary across a one week time period and enter their food and drink consumed into the Research Food Diary app (Xyris Software)
Timepoint [6] 405802 0
4-months and 12-months post-stroke
Secondary outcome [7] 405803 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 7. gut microbiome. Microbial sequencing will take place on stool samples provided by participants.
Timepoint [7] 405803 0
4-months and 12-months post-stroke
Secondary outcome [8] 405804 0
Impact of a prescribed 8-week cardiorespiratory fitness training 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 [8] 405804 0
12-months post-stroke
Secondary outcome [9] 405805 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on changes in neurocognitive function and mood state as measured by a neuropsychological assessment battery.
Timepoint [9] 405805 0
4-months and 12-months post-stroke
Secondary outcome [10] 405806 0
To explore the feasibility of a home-based telehealth delivered cardiorespiratory fitness training intervention
Timepoint [10] 405806 0
8-week intervention delivered between 2-months and 4-months post-stroke
Secondary outcome [11] 411828 0
Impact of a prescribed 8-week cardiorespiratory fitness training intervention at 2-months after ischaemic stroke on: 2. Changes in neurocognitive function as measured via change in ADAS-Cog scores.
Timepoint [11] 411828 0
12-months post-stroke

Eligibility
Key inclusion criteria
- Ischaemic stroke (first or recurrent 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 dementia;
- Can give informed consent and participate in cognitive testing.
Minimum age
18 Years
Maximum age
No limit
Sex
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 Monash University 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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
11/01/2017
Date of last participant enrolment
Anticipated
29/02/2024
Actual
12/02/2024
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
154
Accrual to date
Final
109
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 hospital [3] 21616 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 25876 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 13503 0
3084 - Heidelberg
Recruitment postcode(s) [2] 13504 0
3128 - Box Hill
Recruitment postcode(s) [3] 36543 0
3021 - St Albans
Recruitment postcode(s) [4] 41709 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 293968 0
Charities/Societies/Foundations
Name [1] 293968 0
Heart Foundation
Country [1] 293968 0
Australia
Funding source category [2] 310680 0
Government body
Name [2] 310680 0
National Health and Medical Research Council
Country [2] 310680 0
Australia
Funding source category [3] 310681 0
Charities/Societies/Foundations
Name [3] 310681 0
Stroke Foundation
Country [3] 310681 0
Australia
Primary sponsor type
Other
Name
Monash University
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
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67046 0
Prof Amy Brodtmann
Address 67046 0
Monash University, Central Clinical School
Level 5, The Alfred Centre
99 Commercial Road
Melbourne VIC 3008
Country 67046 0
Australia
Phone 67046 0
+61 3 9902 6000
Fax 67046 0
Email 67046 0
amy.brodtmann@monash.edu
Contact person for public queries
Name 67047 0
Ruwayda Haibe
Address 67047 0
Monash University, Central Clinical School
Level 5, The Alfred Centre
99 Commercial Road
Melbourne VIC 3008
Country 67047 0
Australia
Phone 67047 0
+61 466 096 812
Fax 67047 0
Email 67047 0
ruwayda.haibe@monash.edu
Contact person for scientific queries
Name 67048 0
Amy Brodtmann
Address 67048 0
Monash University, Central Clinical School
Level 5, The Alfred Centre
99 Commercial Road
Melbourne VIC 3008
Country 67048 0
Australia
Phone 67048 0
+61 3 9902 6000
Fax 67048 0
Email 67048 0
amy.brodtmann@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial, after de-identification, and after publishing of the main study outcomes.
When will data be available (start and end dates)?
2 years following publication of the primary hypothesis results, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Monash University.
Available for what types of analyses?
Data will be available for any purposes.
How or where can data be obtained?
Access subject to approvals by Principal Investigator Prof Amy Brodtmann - amy.brodtmann@monash.edu +61 3 9902 6000


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.