StrokePROTECTNCT07445841
Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training
A study testing Multimodal Training and Balance, Toning and Stretching in people with Stroke, run by McGill University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Multimodal Training and Balance, Toning and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Mar 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
McMaster University
Hamilton, Ontario, L8S 1C7
- Recruiting
Jewish Rehabilitation Hospital
Laval, Quebec
Marc Roig, +1 450-688-9550 ext. 4217, marc.roigpull@mcgill.ca
Marc Roig
About this study
Official title: Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training: A Bayesian Adaptive Trial (PROTECT)
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.
Read the detailed description
Rationale: Stroke triggers acute vascular and inflammatory mechanisms that predispose the brain to rapid neurodegeneration. Up to 52% of stroke survivors develop cognitive impairment within 6 months and 20% receive a clinical diagnosis of dementia within 5 years. The subacute phase (<6 months) represents a critical window in which the brain may be most responsive to neuroprotective interventions. Multimodal aerobic and resistance training improves cognition in chronic stroke, but whether it improves cognition, neuroimaging markers, and blood biomarkers of dementia risk when delivered during this early window remains unknown.
Aims: To compare the effects of 12 weeks of multimodal exercise (moderate-to-high-intensity resistance and aerobic training) versus a low-intensity community-based stroke exercise comparator on cognition, neuroimaging outcomes, blood biomarkers of cognitive decline and dementia risk in people with subacute stroke.
Sample size estimates: Sample size was estimated via 20,000 Monte Carlo simulations using an Alzheimer's Disease Assessment Scale-Cognitive assessment (ADAS-Cog) effect size of Cohen's d = 0.63 from a previous exercise RCT. The target was ≥80% power to detect this treatment effect at a one-sided Type I error rate of 2.5%, using a weakly informative prior centered at zero with a variance of 100. The minimum required was 45 completers per arm (N = 90) and accounting for 25% attrition, up to 120 participants (60 per arm) will be enrolled.
Methods and design: PROTECT is a 12-week, Phase 3, assessor-blinded, multisite Bayesian adaptive RCT following a two-arm parallel group sequential design with 6- and 12-month follow-up (NCT07445841). Participants will be randomized to multimodal training or the comparator using concealed allocation with permuted blocks of varying sizes. Pre-planned adaptive features include: (1) two interim analyses at 50% and 75% of completers; (2) early stopping for efficacy and futility; and (3) sample size re-estimation.
Study outcomes: The primary outcome is cognition, measured using the 13-item ADAS-Cog. Secondary outcomes include ADAS-Cog-Plus, structural and perfusion neuroimaging, and blood biomarkers of inflammation and neurodegeneration. Tertiary outcomes will include cardiorespiratory fitness, functional mobility, muscle strength, body composition, neuropsychological battery, patient-reported cognition, quality of life, fatigue, and healthcare utilization. Outcomes will be assessed at baseline, post-intervention (primary endpoint) and at 6- and 12-month follow-up.
Expertise: Our team includes a diverse group of physical therapists, kinesiologists, neurologists, neuroscientists, neuroimmunologists, physicists, biostatisticians and clinicians at different career stages. We have expertise in exercise RCTs post-stroke and the development of novel imaging and blood predictive biomarkers of dementia risk.
Expected outcomes: We expect that multimodal training will be more effective at improving cognition and that differences between groups will persist 12 months after training, indicating a long-lasting protective effect of multimodal training when introduced in early stages of stroke recovery. We also expect that, compared with the control condition, multimodal training will increase more significantly cerebral blood flow and reduce blood brain barrier permeability as well as the concentration of blood biomarkers of inflammation, neurodegeneration, and axonal injury. We anticipate that the identification of associations between changes in biomarkers and cognition will provide important insights about the mechanisms by which exercise can protect the brain against early neurodegeneration post-stroke.
Significance: Patients with stroke have identified the development of interventions to reduce cognitive dysfunction as the most important problem that research must address. However, cognitive post- stroke impairment is commonly neglected and there is a lack of interventions specifically designed to mitigate this problem. This project will determine if exercise implemented in early stages of recovery can reduce the burden of accelerated cognitive decline and dementia risk in these patients.
- Conditions
- Stroke
- Being tested
- Multimodal Training, Balance, Toning and Stretching
- Keywords
- multimodal exercise, cognition, blood brain barrier permeability, cerebral blood flow, inflammation, neurodegeneration, subacute stroke
- Medical subject headings
- Stroke, Inflammation, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal TrainingOther
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 StretchingOther
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%.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Exercise | Experimental | Twelve weeks of combined resistance and aerobic exercise training held three times per week. Receives: 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. Receives: Other: Balance, Toning and Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)
Secondary outcomes (8)
Cognition
The Alzheimer's Disease Assessment Scale-Cognitive Plus Assessment (ADAS-Cog-Plus) is a secondary global cognitive outcome. This cognitive outcome is a composite score that includes the Trail Making Test Parts A and B, Digit Span Forward and Backward, Digit Symbol Substitution, and Category Fluency (Animals and Vegetables), which has been shown to be more responsive to the original ADAS-Cog and is responsive to change following exercise training in chronic stroke. The ADAS-Cog-Plus is scored via a multidimensional item response theory model that provides a global score that is calibrated with the Alzheimer's Disease Neuroimaging Initiative 1 with scores ranging from ≈-1.0 to 1.0, indicating cognitively healthy (-1.0), mild cognitive impairment (≈0.0), and dementia (≈1.0) (Mungas et al., 2013). There are no published MCIDs for the ADAS-Cog-Plus.
Measured: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)
Cerebral Blood Flow
Resting cerebral blood flow (CBF) will be assessed using non-invasive pseudo-continuous arterial spin labelling (ASL). A T1-weighted magnetization-prepared-rapid-acquisition-of-gradient-echo (MPRAGE) structural MRI scan will be first acquired. CBF will be calculated from the ASL control-tag volume image pair difference.
Measured: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
Blood Brain Barrier Permeability
Blood-Brain-Barrier permeability will be measured with a novel water-extraction with phase-contrast-arterial-spin-tagging (WEPCAST) MRI method that does not require the administration of a contrast agent.
Measured: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
White Matter Structure and Integrity
White Matter Structure and Integrity will be measured using diffusion-weighted MRI
Measured: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
Cerebral Blood Velocity (Middle Cerebral Artery Velocity)
A standardized cerebrovascular assessment of cerebral blood velocity (CBV) of the left and right middle cerebral artery will be conducted using Transcranial Doppler Ultrasound. CBV will be assessed in the supine resting state (~15 minutes), and in response to a cognitive tasks (~5 minutes), a brief bout of resistance (~5 minutes) and aerobic exercise stimuli (~15 minutes) to evaluate the hemodynamic response to various stimuli. For the resistance exercise stimuli, the blood velocity response will be assessed in response to a repeated sit-to-stand maneuver at both 0.05Hz (10s sit, 10s stand) and 0.1Hz (5s sit, 5s stand) over a duration of 5 minutes. Once all systemic and cerebral hemodynamic variables have returned to resting levels, participants will then complete the aerobic exercise stimuli which will include a 10-15 minute bout of graded aerobic exercise using a validated graded exercise test.
Measured: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and follow-up at 12 months (T3)
Inflammation
A multiplex assay kit will be used to analyze the blood serum concentration of a panel of inflammatory biomarkers (IL-6, IL-10, TNF-alpha, IL-1beta, IL-18, CRP, GDF-15, MPO, MCP-1) associated with vascular risk, neurodegeneration, and cognitive decline.
Measured: Baseline (T0), 12-week post-intervention (T1), and follow-up at 6 (T2), and 12 months (T3)
Neurodegeneration
Validated assay kits to assess blood serum and plasma concentrations of total and β-amyloid ratios (42:40), total and phosphorylated isoforms of tau (p-tau 181 and 217) and klotho will be collected at all time points.
Measured: Baseline (T0), 12-week post-intervention (T1), and follow-up at 6 (T2), and 12 months (T3)
Axonal Injury
Blood serum samples will be taken and an immunoassay with excellent sensitivity will be used to quantify serum Nfl concentrations.
Measured: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 (T2) and 12 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start9 Mar 2026
- Primary completion30 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group staggered entry parallel single blind multisite adaptive RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, McMaster University, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Montreal Neurological Institute and Hospital
- Responsible party
- Principal investigator, Marc Roig, McGill University
- Investigators
- Marc Roig, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445841
- Sponsor's protocol ID
- 525414
- Acronym
- PROTECT
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets that are prepared and/or analyzed during the current study will be available in the repository of journals upon publication. We will state in the published articles that data are available upon reasonable request to corresponding author Dr. Marc Roig.
Publications
Moncion K, Rodrigues L, Bon A, Sutoski A, Sikorska K, Allison EY, Abreu J, Golchi S, Arbour N, Gauthier C, Paquette C, Rosa-Neto P, Leppert I, Rowley C, Tardiff CL, Thiel A, Al-Khazraji B, Tang A, Roig M. Protecting the brain from post-stroke cognitive impairment and dementia with multimodal exercise training: study protocol for a Bayesian adaptive trial (PROTECT). BMJ Open. 2026 Jul 28;16(7):e123336. doi: 10.1136/bmjopen-2026-123336.
PubMed 42521309
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training: A Bayesian Adaptive Trial (PROTECT)
- ClinicalTrials.gov ID
- NCT07445841
- Acronym / sponsor ID
- PROTECT / 525414
- Conditions
- Stroke
- Keywords
- multimodal exercise, cognition, blood brain barrier permeability, cerebral blood flow, inflammation, neurodegeneration, subacute stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, McMaster University, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, Montreal Neurological Institute and Hospital
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Stroke triggers acute vascular and inflammatory mechanisms that predispose the brain to rapid neurodegeneration. Up to 52% of stroke survivors develop cognitive impairment within 6 months and 20% receive a clinical diagnosis of dementia within 5 years. The subacute phase (<6 months) represents a critical window in which the brain may be most responsive to neuroprotective interventions. Multimodal aerobic and resistance training improves cognition in chronic stroke, but whether it improves cognition, neuroimaging markers, and blood biomarkers of dementia risk when delivered during this early window remains unknown.
Aims: To compare the effects of 12 weeks of multimodal exercise (moderate-to-high-intensity resistance and aerobic training) versus a low-intensity community-based stroke exercise comparator on cognition, neuroimaging outcomes, blood biomarkers of cognitive decline and dementia risk in people with subacute stroke.
Sample size estimates: Sample size was estimated via 20,000 Monte Carlo simulations using an Alzheimer's Disease Assessment Scale-Cognitive assessment (ADAS-Cog) effect size of Cohen's d = 0.63 from a previous exercise RCT. The target was ≥80% power to detect this treatment effect at a one-sided Type I error rate of 2.5%, using a weakly informative prior centered at zero with a variance of 100. The minimum required was 45 completers per arm (N = 90) and accounting for 25% attrition, up to 120 participants (60 per arm) will be enrolled.
Methods and design: PROTECT is a 12-week, Phase 3, assessor-blinded, multisite Bayesian adaptive RCT following a two-arm parallel group sequential design with 6- and 12-month follow-up (NCT07445841). Participants will be randomized to multimodal training or the comparator using concealed allocation with permuted blocks of varying sizes. Pre-planned adaptive features include: (1) two interim analyses at 50% and 75% of completers; (2) early stopping for efficacy and futility; and (3) sample size re-estimation.
Study outcomes: The primary outcome is cognition, measured using the 13-item ADAS-Cog. Secondary outcomes include ADAS-Cog-Plus, structural and perfusion neuroimaging, and blood biomarkers of inflammation and neurodegeneration. Tertiary outcomes will include cardiorespiratory fitness, functional mobility, muscle strength, body composition, neuropsychological battery, patient-reported cognition, quality of life, fatigue, and healthcare utilization. Outcomes will be assessed at baseline, post-intervention (primary endpoint) and at 6- and 12-month follow-up.
Expertise: Our team includes a diverse group of physical therapists, kinesiologists, neurologists, neuroscientists, neuroimmunologists, physicists, biostatisticians and clinicians at different career stages. We have expertise in exercise RCTs post-stroke and the development of novel imaging and blood predictive biomarkers of dementia risk.
Expected outcomes: We expect that multimodal training will be more effective at improving cognition and that differences between groups will persist 12 months after training, indicating a long-lasting protective effect of multimodal training when introduced in early stages of stroke recovery. We also expect that, compared with the control condition, multimodal training will increase more significantly cerebral blood flow and reduce blood brain barrier permeability as well as the concentration of blood biomarkers of inflammation, neurodegeneration, and axonal injury. We anticipate that the identification of associations between changes in biomarkers and cognition will provide important insights about the mechanisms by which exercise can protect the brain against early neurodegeneration post-stroke.
Significance: Patients with stroke have identified the development of interventions to reduce cognitive dysfunction as the most important problem that research must address. However, cognitive post- stroke impairment is commonly neglected and there is a lack of interventions specifically designed to mitigate this problem. This project will determine if exercise implemented in early stages of recovery can reduce the burden of accelerated cognitive decline and dementia risk in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group staggered entry parallel single blind multisite adaptive RCT
| Arm | Type | Receives |
|---|---|---|
| Multimodal Exercise | Experimental | Other: Multimodal TrainingTwelve weeks of combined resistance and aerobic exercise training held three times per week. |
| Balance, Toning and Stretching | Active comparator | Other: Balance, Toning and StretchingTwelve 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal TrainingTraining 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. | Other | Multimodal Exercise |
| Balance, Toning and StretchingSessions 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%. | Other | Balance, Toning and Stretching |
Primary outcome
Cognition
Time frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)
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.
8 secondary outcomes
Cognition
Time frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)
Cerebral Blood Flow
Time frame: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
Blood Brain Barrier Permeability
Time frame: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
White Matter Structure and Integrity
Time frame: Baseline (T0), 12-week post-intervention (T1), and follow-up at 12 months (T3)
Cerebral Blood Velocity (Middle Cerebral Artery Velocity)
Time frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and follow-up at 12 months (T3)
Inflammation
Time frame: Baseline (T0), 12-week post-intervention (T1), and follow-up at 6 (T2), and 12 months (T3)
Neurodegeneration
Time frame: Baseline (T0), 12-week post-intervention (T1), and follow-up at 6 (T2), and 12 months (T3)
Axonal Injury
Time frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 (T2) and 12 months (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42521309Moncion K, Rodrigues L, Bon A, Sutoski A, Sikorska K, Allison EY, Abreu J, Golchi S, Arbour N, Gauthier C, Paquette C, Rosa-Neto P, Leppert I, Rowley C, Tardiff CL, Thiel A, Al-Khazraji B, Tang A, Roig M. Protecting the brain from post-stroke cognitive impairment and dementia with multimodal exercise training: study protocol for a Bayesian adaptive trial (PROTECT). BMJ Open. 2026 Jul 28;16(7):e123336. doi: 10.1136/bmjopen-2026-123336.
- Individual participant dataSharing planned: Yes. Anonymized datasets that are prepared and/or analyzed during the current study will be available in the repository of journals upon publication. We will state in the published articles that data are available upon reasonable request to corresponding author Dr. Marc Roig.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Roig principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Training and Balance, Toning and Stretching in people with Stroke, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Roig (514-398-4400 ext. 00841, marc.roigpull@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Baseline (T0), 12-week post-intervention (T1), follow-up at 6 months (T2) and 12 months (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.