Protecting the brain after stroke with multimodal exercise
Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training
This test tries a 12-week multimodal exercise program for people within six months of a first stroke to see if it preserves thinking skills and lowers brain markers linked to dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT07445841 on ClinicalTrials.gov |
What this trial studies
This multisite, single-blind randomized trial will compare 12 weeks of multimodal exercise training to 12 weeks of balance, toning, and stretching in people in the subacute period after a first stroke. Participants are enrolled at centers in Ontario and Quebec and undergo blinded assessments at baseline, after the intervention, and at 6- and 12-month follow-ups. Primary outcomes include cognitive performance measured with the ADAS-Cog13 Plus, and secondary outcomes include MRI measures of cerebral blood flow, blood–brain barrier permeability, and blood biomarkers of inflammation. The design uses staggered entry and an adaptive framework to optimize group comparisons while monitoring safety and adherence.
Who should consider this trial
Good fit: Ideal candidates are adults who had a first ischemic or hemorrhagic stroke 0–6 months ago, can walk at least 10 meters (assistive devices allowed), can follow instructions, have no dementia diagnosis, and have no contraindications to exercise or MRI.
Not a fit: Patients with pre-existing dementia, major disability (modified Rankin score >3), severe untreated depression, severe communication or behavioral issues, or medical conditions that prevent safe exercise or MRI are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this program could slow post-stroke cognitive decline and reduce biological signals linked to future dementia risk.
How similar studies have performed: Prior post-stroke exercise studies have shown some modest cognitive and vascular benefits, but evidence for early multimodal programs specifically reducing dementia risk is limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * have had a first-ever ischemic/hemorrhagic stroke confirmed by MRI/CT 0-6 months prior to participation. * Able to independently walk at least 10 meters (assistive devices permitted) and capable of following instructions will be required. Exclusion Criteria: * Diagnosed with dementia * Absolute contraindications to exercise or MRI scanning * Significant disability (modified Rankin score \>3) * Severe untreated depression (Beck Depression Inventory II score \>28) * Participants will be excluded if they have been engaged in a structured exercise training program outside their regular in/out-patient hospital rehabilitation since suffering the stroke. * Co-morbidities that preclude exercise participation, pain worsened with exercise, and communication (e.g., severe aphasia) or behavioral issues limiting safe participation will also be reasons for exclusion.
Where this trial is running
Hamilton, Ontario and 1 other locations
- McMaster University — Hamilton, Ontario, Canada (Active_not_recruiting)
- Jewish Rehabilitation Hospital — Laval, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Marc Roig — McGill University
- Study coordinator: Marc Roig
- Email: marc.roigpull@mcgill.ca
- Phone: 514-398-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.