Recruiting

Multimodal Exercise

Sponsor:

McGill University

Code:

NCT07445841

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Multimodal Training

Balance, Toning and Stretching

Study Details

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

Study ID

NCT07445841

Start date

Mar 9, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jan 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Multimodal Exercise

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

active comparator: Balance, Toning and Stretching

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.

Interventions

Multimodal Training

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.

Balance, Toning and Stretching

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%.

Primary outcome measure

  • Cognition [ Time Frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3) ]

Central Contacts and Locations

Central contacts

Locations

Jewish Rehabilitation Hospital

Recruiting

Laval, Quebec, Canada

Contacts

Principal Investigator:

Marc Roig

More Information

Sponsor

McGill University

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2026-07-06.