StrokeEX-ML3NCT02980796
The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke
A study testing Exercise and Practice in people with Stroke and Exercise, run by University of British Columbia at 1 site in Canada.
Trial summary
Participants will complete 11 sessions. These include screening, 5 sessions where exercise or rest (according to group assignment) are paired with practice of a motor task, MRI and Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to assess neuroplasticity (ability for the brain to… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Exercise and Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 40 - 85
- Had a stroke at least 12 months ago
- OR are a healthy adult who does not have a history of neurodegenerative disorders
- Have the ability to understand English
Who cannot join
- Contraindication to brain stimulation (such as a history of seizure or epilepsy)
- Contraindication to MRI (such as a pacemaker, metal in the eyes / brain or fear of enclosed spaces)
- Neurodegenerative disorder ( such as Parkinson disease, Alzheimers disease or Multiple Sclerosis)
- Contraindications to exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 2B5
Asha Toner, BSc, 604-828-6303, asha.toner@ubc.ca
Tamara Koren, MSc, 604-822-6886, tamara.koren@ubc.ca
About this study
Official title: The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke
Participants will complete 11 sessions. These include screening, 5 sessions where exercise or rest (according to group assignment) are paired with practice of a motor task, MRI and Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to assess neuroplasticity (ability for the brain to reorganize and create new connections).
Read the detailed description
All participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe participation in aerobic exercise (testing session [s] 1); and 2) magnetic resonance imaging (MRI) to assess brain structure and function, and 3) clinical assessments of motor function and activity. The MRI and clinical tests will be completed on s2. Between the exercise test and MRI sessions individuals will wear accelerometers for 3 days to index usual activity levels. A custom computer program will then assign participants quasi-randomly to either the rest or exercise groups stratified on age, sex, and baseline motor function. Cortical excitability will be assessed before and after either a single session of priming aerobic exercise, or rest, by group (s3). Next, priming exercise will be paired with skilled motor practice for 5 sessions (s4-8). Practice sessions will be separated by 48 hours. Importantly motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and 30-days (s11) after the last practice session. Activity levels (3 day accelerometry), TMS and MRI measures will be re-assessed after the second retention test (s10).
- Being tested
- Exercise, Practice
- Keywords
- Brain, MRI, Exercise, Rehabilitation, TMS
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Each experimental day participants will complete an acute bout of exercise on a recumbent bike.
PracticeBehavioural
Each experimental day participants will complete a session of skilled motor practice.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + practice | Experimental | Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task. Receives: Behavioral: Exercise; Behavioral: Practice |
| Rest + practice | Active comparator | Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time. Receives: Behavioral: Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change response time during a novel motor task.
Serial targeting task
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Wolf Motor Function Task Rate
Standardized test of arm motor function
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary outcomes (5)
Transcallosal Inhibition
Ipsilateral silent period
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Arm Use Ratio
Accelerometry
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Functional magnetic resonance imaging (fMRI)
Resting state fMRI
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Structural magnetic resonance imaging - myelin
Myelin water fraction
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Structural magnetic resonance imaging - diffusion
Diffusion weighted fractional anisotrophy
Measured: Baseline, After Intervention (2 weeks), 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Boyd, University of British Columbia
- Investigators
- Lara Boyd, Pt, PhD, Principal investigator, Univeristy of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980796
- Sponsor's protocol ID
- H16-01945
- Acronym
- EX-ML3
- Status last verified
- Aug 2017
- First submitted
- 28 Nov 2016
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
PubMed 34695300
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke
- ClinicalTrials.gov ID
- NCT02980796
- Acronym / sponsor ID
- EX-ML3 / H16-01945
- Keywords
- Brain, MRI, Exercise, Rehabilitation, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will complete 11 sessions. These include screening, 5 sessions where exercise or rest (according to group assignment) are paired with practice of a motor task, MRI and Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to assess neuroplasticity (ability for the brain to reorganize and create new connections).
Detailed description
All participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe participation in aerobic exercise (testing session [s] 1); and 2) magnetic resonance imaging (MRI) to assess brain structure and function, and 3) clinical assessments of motor function and activity. The MRI and clinical tests will be completed on s2. Between the exercise test and MRI sessions individuals will wear accelerometers for 3 days to index usual activity levels. A custom computer program will then assign participants quasi-randomly to either the rest or exercise groups stratified on age, sex, and baseline motor function. Cortical excitability will be assessed before and after either a single session of priming aerobic exercise, or rest, by group (s3). Next, priming exercise will be paired with skilled motor practice for 5 sessions (s4-8). Practice sessions will be separated by 48 hours. Importantly motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and 30-days (s11) after the last practice session. Activity levels (3 day accelerometry), TMS and MRI measures will be re-assessed after the second retention test (s10).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + practice | Experimental | Behavioral: Exercise, Behavioral: PracticeIndividuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task. |
| Rest + practice | Active comparator | Behavioral: PracticeIndividuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 40 - 85
- Had a stroke at least 12 months ago
- OR are a healthy adult who does not have a history of neurodegenerative disorders
- Have the ability to understand English
Key exclusion criteria (4 listed)
- Contraindication to brain stimulation (such as a history of seizure or epilepsy)
- Contraindication to MRI (such as a pacemaker, metal in the eyes / brain or fear of enclosed spaces)
- Neurodegenerative disorder ( such as Parkinson disease, Alzheimers disease or Multiple Sclerosis)
- Contraindications to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEach experimental day participants will complete an acute bout of exercise on a recumbent bike. | Behavioural | Exercise + practice |
| PracticeEach experimental day participants will complete a session of skilled motor practice. | Behavioural | Exercise + practice, Rest + practice |
Primary outcome
Change response time during a novel motor task.
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Serial targeting task
Wolf Motor Function Task Rate
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Standardized test of arm motor function
5 secondary outcomes
Transcallosal Inhibition
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Arm Use Ratio
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Functional magnetic resonance imaging (fMRI)
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Structural magnetic resonance imaging - myelin
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Structural magnetic resonance imaging - diffusion
Time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 34695300Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Boyd, Pt, PhD principal investigator
Univeristy of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Practice in people with Stroke and Exercise, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asha Toner, BSc (604-828-6303, asha.toner@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change response time during a novel motor task. (time frame: Baseline, After Intervention (2 weeks), 30-day follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.