Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001306606
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
14/12/2023
Date last updated
14/12/2023
Date data sharing statement initially provided
14/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of exercise intensity on biomarkers, and brain function after stroke
Scientific title
The effect of exercise intensity on biomarkers of stress, inflammation, and brain function after stroke
Secondary ID [1] 310909 0
Nil known
Universal Trial Number (UTN)
U1111-1300-1160
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 331970 0
Condition category
Condition code
Stroke 328706 328706 0 0
Ischaemic
Stroke 328708 328708 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 328709 328709 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will perform two exercise sessions one 21 minutes session of moderate intensity aerobic interval training i.e. 40-60% of Heart Rate Reserve and one high intensity exercise i.e. 70-85% HRR. Intervals are 90 seconds with an active rest period of at low intensity (~20-30% HRR). The session will take place face-to face in a research clinic. There will be a wash out period between exercise sessions of at least 60 minutes.

The order of the sessions will be randomised.
Session will be supervised by a physiotherapist and a trained clinical research assistant.

Exercise will be performed on a recumbent bike and will be precede by a 5 minute warm up and after completion participants will perform a 3-5 minute cool down. The warm up and cool down will be performed on the exercise equipment i.e. recumbent bike, cycle ergometer or treadmill, in which the session will be performed. The choice of exercise equipment will be based on availability and preference of the participant and will consistent for both sessions.
Intervention code [1] 327359 0
Rehabilitation
Comparator / control treatment
The effects of moderate intensity exercise will be compared to the effects of high intensity exercise, where high intensity exercise session is the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 336542 0
Stress: Salivary Cortisol
Timepoint [1] 336542 0
Immediately after each of the exercise sessions
Primary outcome [2] 336543 0
Inflammatory biomarker: salivary C-reactive protein
Timepoint [2] 336543 0
Immediately after each of the exercise sessions
Secondary outcome [1] 428743 0
Corticomotor excitability: resting motor threshold
Timepoint [1] 428743 0
Immediately after each of the exercise sessions
Secondary outcome [2] 428744 0
Corticomotor excitability: recruitment curve
Timepoint [2] 428744 0
Immediately after each of the exercise sessions
Secondary outcome [3] 428745 0
Motor map size
Timepoint [3] 428745 0
Immediately after each of the exercise sessions

Eligibility
Key inclusion criteria
Eligibility criteria:
Adult (>21 years of age) stroke survivors
Are eligible for Medicare
Clinically diagnosed with first ever ischaemic/haemorrhagic stroke
Stroke onset between 1 – 12 months ago at enrolment.
Medically stable
No contra-indications to perform moderate to high-intensity exercise.
Able to follow instructions and give written consent

Adult healthy age and sex matched controls (>21 years of age)
Are eligible for Medicare.
Relatively healthy individuals with no contraindications to perform exercise
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Severe cardiac comorbidities such as unstable angina, severe aortic stenosis etc.
Neurological comorbidities other than stroke such as Parkinson’s disease, Multiple Sclerosis etc.
Severe musculoskeletal comorbidities
Severe respiratory comorbidities such as severe COPD, pulmonary fibrosis
Pacemaker implant
Patients or healthy individuals with metal ferromagnetic objects implanted in the head or neck area.

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 will be concealed by using a central randomisation via computer using RedCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated sing a central randomisation via computer using RedCap
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Demographic data will be analysed descriptively; data will be reported as medians and interquartile ranges of means and standard deviations where appropriate.
Saliva analyses will be performed using validated ELISA kits, as well as standardized gene expression techniques, within the Monash Neuroscience Laboratories, by staff blinded to the exercise protocol associated with the samples. Experiments will be conducted as per the instructions of the kit manufacturers. The analyses do not include genetic testing identifying alleles or SNPs that confer genetic risk for any diseases or disorders.
Differences between biomarker levels will be estimated using t-tests for the following comparisons
• Post moderate intensity exercise vs post high-intensity exercise in stroke survivors
• Post moderate intensity exercise vs post high intensity exercise in healthy age-matched controls
• Post moderate intensity exercise between stroke survivors and healthy age and sex-matched controls
• Post high-intensity exercise intensity between stroke survivors and healthy age and sex-matched controls

Analyses will be adjusted for time of assessment since waking and saliva levels at rest if appropriate.

TMS analyses will include estimating differences in resting motor threshold after moderate and high-intensity exercise for stroke survivors and healthy controls separately and between moderate and high-intensity exercise between groups
The same comparison will be used to estimate differences in area under the MEP curve.
Differences between summarised group data will be estimated using Mann Whitney (for unpaired data) and Wilcoxon rank sum test (for paired data) for nonparametric data, and t-test and paired t-test will be used for parametric data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315169 0
University
Name [1] 315169 0
Monash University
Country [1] 315169 0
Australia
Primary sponsor type
Individual
Name
Sharon Kramer
Address
Level 6, Alfred Centre, 99 Commercial Rd, Prahan, VIC 3004
Country
Australia
Secondary sponsor category [1] 317185 0
None
Name [1] 317185 0
Address [1] 317185 0
Country [1] 317185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314102 0
Ethics Committee Alfred health
Ethics committee address [1] 314102 0
Ethics committee country [1] 314102 0
Australia
Date submitted for ethics approval [1] 314102 0
27/07/2023
Approval date [1] 314102 0
12/09/2023
Ethics approval number [1] 314102 0
99939

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130418 0
Dr Sharon Kramer
Address 130418 0
Department of Neuroscience, Monash University, Level 6 Alfred Centre, 99 Commercial Rd. Prahan VIC 3004
Country 130418 0
Australia
Phone 130418 0
+61 477537531
Fax 130418 0
Email 130418 0
[email protected]
Contact person for public queries
Name 130419 0
Sharon Kramer
Address 130419 0
Department of Neuroscience, Monash University, Level 6 Alfred Centre, 99 Commercial Rd. Prahan VIC 3004
Country 130419 0
Australia
Phone 130419 0
+61 477537531
Fax 130419 0
Email 130419 0
[email protected]
Contact person for scientific queries
Name 130420 0
Sharon Kramer
Address 130420 0
Department of Neuroscience, Monash University, Level 6 Alfred Centre, 99 Commercial Rd. Prahan VIC 3004
Country 130420 0
Australia
Phone 130420 0
+61 477537531
Fax 130420 0
Email 130420 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
due to hospital data requirement we can not share data


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.