Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training

NCT07445841 | Recruiting DMC

• 1 other identifier: 525414
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The rates of cognitive decline and dementia after stroke are disproportionately high. Strategies that can protect the brain early after the stroke event could reduce the future risk of cognitive decline and dementia in these patients. Although physical exercise is usually recommended after stroke, there is very little information about the protective effect of exercise implemented in early stages of recovery as a potential protective measure against cognitive decline and dementia risk in these patients. This study will investigate the effect of a multimodal exercise intervention implemented early after the stroke event on cognition and on a selected group of markers that can predict cognitive decline and dementia risk.

Conditions

Stroke

Keywords

multimodal exercise; cognition; blood brain barrier permeability; cerebral blood flow; inflammation; neurodegeneration; subacute stroke

Outcome Measures

Primary Outcomes (1)

• Cognition

  The primary outcome will be change in cognition immediately post-intervention (T1, primary endpoint) as measured by the ADAS-Cog-13, a 13-item cognitive assessment with scores ranging from 0 to 85, where lower scores indicate better cognition. The minimal clinical importance difference (MCID) on this scale is 2.

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)

Secondary Outcomes (8)

• Cognition

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)

• Cerebral Blood Flow

  Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)

• Blood Brain Barrier Permeability

  Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)

• White Matter Structure and Integrity

  Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)

• Cerebral Blood Velocity (Middle Cerebral Artery Velocity)

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and follow-up at 12 months (T3)

Other Outcomes (10)

• Cardiorespiratory Fitness

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)

• Physical Function

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 (T2) and 12 months (T3)

• Functional mobility

  Baseline (T0), 12-week post-intervention (T1), follow-up at 6 (T2) and 12 months (T3)

Study Arms (2)

Multimodal Exercise

EXPERIMENTAL

Twelve weeks of combined resistance and aerobic exercise training held three times per week.

Other: Multimodal Training

Balance, Toning and Stretching

ACTIVE COMPARATOR

Twelve weeks of low-intensity task-specific strengthening, balance, mobility, and stretching training held three times per week that is based off the Fitness and Mobility Exercise Program.

Other: Balance, Toning and Stretching

Interventions

Multimodal Training OTHER

Training sessions, which will include resistance training followed by aerobic exercise training, will start with \~5 minutes of warm-up and end with \~5 minutes of cool down. Resistance training (20-30 minutes) will involve one day of upper limb, one day of lower limb and one day of full body exercises involving major muscle groups. Each session will include 5 exercises for 2-3 sets x 10 repetitions. Workloads will be increased from moderate to vigorous intensities (≥50-85% 1-RM; RPE≥14/20) by adding movement modifications and/or increasing resistance to ensure progressive overload. The first 4 weeks of aerobic exercise will involve 20 minutes of moderate intensity continuous training (40-60% HRR; RPE\<13/20). The following 4 weeks, will involve 3x4 minutes (long-interveral) high intensity interval training (HIIT) at ≥60-80% HRR; RPE=≥14-17. The last 4 weeks will involve 10, 1x1 minutes (short-interval) HIIT at ≥80-100% HRR; RPE≥17/20.

Multimodal Exercise

Balance, Toning and Stretching OTHER

Sessions will be performed at light intensity (\<40% HRR) and finalize with a 5-minute cool-down. During the 40-60 minute session, 5 to 6 exercises (2-3 sets x 10 reps) involving balance, toning and stretching will be performed. Participants will progress through increasingly challenging exercises (e.g., reduce base of support in balance exercises), but they will aim to maintain a HRR \<40%.

Balance, Toning and Stretching

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Neurological Institute and Hospital: collaborator
• McGill University: lead
• Jewish Rehabilitation Hospital: collaborator
• McMaster University: collaborator
• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: collaborator

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

ACTIVE NOT RECRUITING

Jewish Rehabilitation Hospital

Laval, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Inflammation; Nerve Degeneration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Roig

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Roig

CONTACT

514-398-4400; marc.roigpull@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-group staggered entry parallel single blind multisite adaptive RCT

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 3, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (2)