NCT02980796

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

November 28, 2016

Last Update Submit

August 11, 2017

Conditions

StrokeExerciseRest

Keywords

BrainMRIExerciseRehabilitationTMS

Outcome Measures

Primary Outcomes (2)

  • Change response time during a novel motor task.

    Serial targeting task

    Baseline, After Intervention (2 weeks), 30-day follow-up

  • Wolf Motor Function Task Rate

    Standardized test of arm motor function

    Baseline, After Intervention (2 weeks), 30-day follow-up

Secondary Outcomes (5)

  • Transcallosal Inhibition

    Baseline, After Intervention (2 weeks), 30-day follow-up

  • Arm Use Ratio

    Baseline, After Intervention (2 weeks), 30-day follow-up

  • Functional magnetic resonance imaging (fMRI)

    Baseline, After Intervention (2 weeks), 30-day follow-up

  • Structural magnetic resonance imaging - myelin

    Baseline, After Intervention (2 weeks), 30-day follow-up

  • Structural magnetic resonance imaging - diffusion

    Baseline, After Intervention (2 weeks), 30-day follow-up

Study Arms (2)

Exercise + practice

EXPERIMENTAL

Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.

Behavioral: ExerciseBehavioral: Practice

Rest + practice

ACTIVE COMPARATOR

Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.

Behavioral: Practice

Interventions

ExerciseBEHAVIORAL

Each experimental day participants will complete an acute bout of exercise on a recumbent bike.

Exercise + practice
PracticeBEHAVIORAL

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

Exercise + practiceRest + practice

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34695300DERIVED

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lara Boyd, Pt, PhD

    Univeristy of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asha Toner, BSc

CONTACT

604-828-6303asha.toner@ubc.ca

Jason Neva, PhD

CONTACT

604-827-3369jason.neva@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 2, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

CA(1)