ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 4738 for:    British | Canada

The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke (EX-ML3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02980796
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Lara Boyd, University of British Columbia

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).

Condition or disease Intervention/treatment Phase
Stroke Exercise Rest Behavioral: Exercise Behavioral: Practice Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke
Study Start Date : November 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise + practice
Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.
Behavioral: Exercise
Each experimental day participants will complete an acute bout of exercise on a recumbent bike.

Behavioral: Practice
Each experimental day participants will complete a session of skilled motor practice.

Active Comparator: Rest + practice
Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.
Behavioral: Practice
Each experimental day participants will complete a session of skilled motor practice.




Primary Outcome Measures :
  1. Change response time during a novel motor task. [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Serial targeting task

  2. Wolf Motor Function Task Rate [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Standardized test of arm motor function


Secondary Outcome Measures :
  1. Transcallosal Inhibition [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Ipsilateral silent period

  2. Arm Use Ratio [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Accelerometry

  3. Functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Resting state fMRI

  4. Structural magnetic resonance imaging - myelin [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Myelin water fraction

  5. Structural magnetic resonance imaging - diffusion [ Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up ]
    Diffusion weighted fractional anisotrophy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980796


Contacts
Contact: Asha Toner, BSc 604-828-6303 asha.toner@ubc.ca
Contact: Jason Neva, PhD 604-827-3369 jason.neva@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Asha Toner, BSc    604-828-6303    asha.toner@ubc.ca   
Contact: Tamara Koren, MSc    604-822-6886    tamara.koren@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Lara Boyd, Pt, PhD Univeristy of British Columbia

Responsible Party: Lara Boyd, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02980796     History of Changes
Other Study ID Numbers: H16-01945
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lara Boyd, University of British Columbia:
Brain
MRI
Exercise
Rehabilitation
TMS

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases