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

August 11, 2017 updated by: Lara Boyd, University of British Columbia

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Recruiting
        • University of British Columbia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change response time during a novel motor task.
Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Serial targeting task
Baseline, After Intervention (2 weeks), 30-day follow-up
Wolf Motor Function Task Rate
Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Standardized test of arm motor function
Baseline, After Intervention (2 weeks), 30-day follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcallosal Inhibition
Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Ipsilateral silent period
Baseline, After Intervention (2 weeks), 30-day follow-up
Arm Use Ratio
Time Frame: Baseline, After Intervention (2 weeks), 30-day follow-up
Accelerometry
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
Resting state fMRI
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
Myelin water fraction
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
Diffusion weighted fractional anisotrophy
Baseline, After Intervention (2 weeks), 30-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Lara Boyd, Pt, PhD, Univeristy of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H16-01945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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