Protecting the brain after stroke with multimodal exercise
Official title: Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training: A Bayesian Adaptive Trial (PROTECT)
Run by McGill University · NCT07445841 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | McGill University Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | January 30, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07445841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * medically stable * 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 * Medications that impact cognition * Absolute contraindications to exercise or MRI scanning * Significant disability (modified Rankin score \>3) * 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 it's running
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Jewish Rehabilitation Hospital
Laval, Quebec, Canada Recruiting -
McMaster University
Hamilton, Ontario, Canada Active not recruiting
Study contacts
- Principal investigator: Marc Roig — McGill University
- Study coordinator: Marc Roig
- Email: marc.roigpull@mcgill.ca
- Phone: 514-398-4400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.