The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke (EX-ML3)
Primary Purpose
Stroke, Exercise, Rest
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Practice
Sponsored by
About this trial
This is an interventional basic science trial for Stroke focused on measuring Brain, MRI, Exercise, Rehabilitation, TMS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of British ColumbiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise + practice
Rest + practice
Arm Description
Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.
Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.
Outcomes
Primary Outcome Measures
Change response time during a novel motor task.
Serial targeting task
Wolf Motor Function Task Rate
Standardized test of arm motor function
Secondary Outcome Measures
Transcallosal Inhibition
Ipsilateral silent period
Arm Use Ratio
Accelerometry
Functional magnetic resonance imaging (fMRI)
Resting state fMRI
Structural magnetic resonance imaging - myelin
Myelin water fraction
Structural magnetic resonance imaging - diffusion
Diffusion weighted fractional anisotrophy
Full Information
NCT ID
NCT02980796
First Posted
November 28, 2016
Last Updated
August 11, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02980796
Brief Title
The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke
Acronym
EX-ML3
Official Title
The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Exercise, Rest
Keywords
Brain, MRI, Exercise, Rehabilitation, TMS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise + practice
Arm Type
Experimental
Arm Description
Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.
Arm Title
Rest + practice
Arm Type
Active Comparator
Arm Description
Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Each experimental day participants will complete an acute bout of exercise on a recumbent bike.
Intervention Type
Behavioral
Intervention Name(s)
Practice
Intervention Description
Each experimental day participants will complete a session of skilled motor practice.
Primary Outcome Measure Information:
Title
Change response time during a novel motor task.
Description
Serial targeting task
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Title
Wolf Motor Function Task Rate
Description
Standardized test of arm motor function
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Secondary Outcome Measure Information:
Title
Transcallosal Inhibition
Description
Ipsilateral silent period
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Title
Arm Use Ratio
Description
Accelerometry
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Title
Functional magnetic resonance imaging (fMRI)
Description
Resting state fMRI
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Title
Structural magnetic resonance imaging - myelin
Description
Myelin water fraction
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
Title
Structural magnetic resonance imaging - diffusion
Description
Diffusion weighted fractional anisotrophy
Time Frame
Baseline, After Intervention (2 weeks), 30-day follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asha Toner, BSc
Phone
604-828-6303
Email
asha.toner@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Neva, PhD
Phone
604-827-3369
Email
jason.neva@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Boyd, Pt, PhD
Organizational Affiliation
Univeristy of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asha Toner, BSc
Phone
604-828-6303
Email
asha.toner@ubc.ca
First Name & Middle Initial & Last Name & Degree
Tamara Koren, MSc
Phone
604-822-6886
Email
tamara.koren@ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34695300
Citation
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.
Results Reference
derived
Learn more about this trial
The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke
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