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

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02980796

Collaborator

(none)

104

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Stroke Exercise Rest	Behavioral: Exercise Behavioral: Practice	N/A

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

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Transcallosal Inhibition [Baseline, After Intervention (2 weeks), 30-day follow-up]
Ipsilateral silent period
Arm Use Ratio [Baseline, After Intervention (2 weeks), 30-day follow-up]
Accelerometry
Functional magnetic resonance imaging (fMRI) [Baseline, After Intervention (2 weeks), 30-day follow-up]
Resting state fMRI
Structural magnetic resonance imaging - myelin [Baseline, After Intervention (2 weeks), 30-day follow-up]
Myelin water fraction
Structural magnetic resonance imaging - diffusion [Baseline, After Intervention (2 weeks), 30-day follow-up]
Diffusion weighted fractional anisotrophy

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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