Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000339651
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
31/03/2023
Date last updated
31/03/2023
Date data sharing statement initially provided
31/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of exercise on brain function in people with stroke
Scientific title
The effect of a single bout of moderate intensity aerobic exercise on synaptic plasticity in patients presenting with chronic stroke: a pilot randomised-controlled trial
Secondary ID [1] 309245 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 329401 0
Condition category
Condition code
Neurological 326345 326345 0 0
Other neurological disorders
Stroke 326404 326404 0 0
Haemorrhagic
Stroke 326405 326405 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention (exercise) group will complete a single session of 20 minutes of moderate intensity continuous aerobic exercise on a recumbent exercise bike. Participants were monitored to ensure they stay within 60-80% of maximum heart rate which will calculated using the formula: 208-(0.7 x age).

Sessions will be supervised by physiotherapists and delivered one-on-one. Adherence will be monitored by continuous supervision by research staff.

Following exercise or control, all participants will receive intermittent theta burst stimulation (iTBS) to the non-lesioned hemisphere. The standard 600 pulses iTBS paradigm was used, consisting of three low intensity, high frequency pulses (50Hz), applied every 200ms for two seconds, then repeated every 10 seconds for a total of 190 seconds. The intensity of stimulation was set at 70% of RMT. Participants were asked to relax and avoid contraction of the upper limb muscles during delivery and following iTBS. Coil position was consistently monitored to maintain correct positioning. timulation was delivered using a Neuro-MS/D rTMS device (Neurosoft Ltd. Ivanova, Russia) that was connected to an oil cooled figure eight coil (wing diameter 70mm).
Intervention code [1] 325683 0
Treatment: Other
Comparator / control treatment
Those allocated to the control group will be seated in a quiet room and watch a documentary of the same duration (20 minutes) on a television. The documentary will be interesting, but not overstimulating.
Control group
Active

Outcomes
Primary outcome [1] 334199 0
Neuroplasticity as measured by a non-invasive brain stimulation paradigm. Neuroplasticity will be quantified as the effect of iTBS by measuring motor evoked potentials (MEPs) from the first dorsal interosseous (FDI) muscle. Stimulation was delivered using a Neuro-MS/D rTMS device (Neurosoft Ltd. Ivanova, Russia) that was connected to an oil cooled figure eight coil (wing diameter 70mm). Single pulses were delivered every five seconds to the contralesional motor cortex region. The coil was held tangentially to the scalp with the handle positioned at a 45-degree posterolateral angle. The optimal position (over the scalp) for evoking MEPs in the resting FDI muscle was located by systematically moving the coil in small increments, then marked with a permanent marker to ensure consistency for subsequent stimulation. An automated algorithm obtained RMT, defined as the lowest stimulus intensity to evoke a MEP of 0.05mV in the relaxed FDI muscle in at least 5 out of 10 consecutive stimulations. Corticospinal excitability was measured by recording MEPs at 120% RMT and measuring peak-to-peak amplitudes. Blocks of 20 MEPs were completed at each time point (pre-activity (exercise/control), post-activity (exercise/control), 0 minutes post-iTBS, 5 minutes post-iTBS, 10 minutes post-iTBS and 15 minutes post-iTBS) to ensure reliability of MEP amplitude. The FDI was chosen to avoid any potential effect of fatigue on the muscle’s response to stimulation, as it was not directly involved in exercise during the intervention.
Timepoint [1] 334199 0
Immediately post exercise (or control) session.
Secondary outcome [1] 419807 0
None
Timepoint [1] 419807 0
None

Eligibility
Key inclusion criteria
People who had experienced stroke at least three months prior, were community ambulators, medically stable and over the age of 18 years will be invited to participate. Participants must be deemed safe for non-invasive brain stimulation using international guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were previous diagnosis of another neurological disease, recent craniotomy or neurosurgical intervention, any concurrent medication known to modify seizure threshold, presence of contraindications to TMS (such as metallic implants in the skull, history of seizures or implanted permanent pacemaker) or were unable to use an exercise bike.

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 concealed prior to enrolment
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
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
Analysis will be performed using a linear mixed model with Group x Time interraction to evaluate effects of exercise (or control) on Neuroplasticity. Covariates will be included in the model (e.g. age, stimulation threshold, history of physical activity, time since stroke)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2021
Date of last participant enrolment
Anticipated
Actual
21/02/2022
Date of last data collection
Anticipated
Actual
21/02/2022
Sample size
Target
34
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313436 0
University
Name [1] 313436 0
University of South Australia
Country [1] 313436 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide, South Australia 50010
Country
Australia
Secondary sponsor category [1] 315263 0
None
Name [1] 315263 0
None
Address [1] 315263 0
None
Country [1] 315263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312644 0
University of South Australia’s Human Research Ethics Committee
Ethics committee address [1] 312644 0
Ethics committee country [1] 312644 0
Australia
Date submitted for ethics approval [1] 312644 0
Approval date [1] 312644 0
02/07/2021
Ethics approval number [1] 312644 0
203568

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

Contacts
Principal investigator
Name 125402 0
Dr Brenton Hordacre
Address 125402 0
108 North Terrace, Adelaide, South Australia 5001
Country 125402 0
Australia
Phone 125402 0
+61 8 830 21286
Fax 125402 0
Email 125402 0
[email protected]
Contact person for public queries
Name 125403 0
Brenton Hordacre
Address 125403 0
108 North Terrace, Adelaide, South Australia 5001
Country 125403 0
Australia
Phone 125403 0
+61 8 830 21286
Fax 125403 0
Email 125403 0
[email protected]
Contact person for scientific queries
Name 125404 0
Brenton Hordacre
Address 125404 0
108 North Terrace, Adelaide, South Australia 5001
Country 125404 0
Australia
Phone 125404 0
+61 8 830 21286
Fax 125404 0
Email 125404 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


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.