Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2021-06-20
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objectives: To establish whether: 1) cardiovascular exercise improves brain plasticity during the initial phases of post-stroke recovery; 2) carrying a specific form of the BDNF gene modulates the response to cardiovascular exercise.
Design: 70 participants will perform either a progressive high-intensity cardiovascular exercise program or low-intensity stretching and toning exercise program. Both groups will undergo 8 weeks of training performed 3 times per week. Assessments will be performed at the beginning, mid-point (4 weeks) and at the end of the training period (8 weeks).
Methodology: Assessments: 1) brain plasticity by measuring changes in brain excitability, a marker of brain plasticity, with non-invasive brain stimulation; 2) BDNF levels by measuring the blood concentration of this protein; 3) Genotype by identifying the subtype of BDNF gene carried by each participant; 4) Cardiorespiratory fitness by assessing the performance during a graded exercise test.
Statistical analysis: Differences between exercise and control groups on the primary endpoint of all outcomes will be analyzed with linear mixed models. Besides baseline scores, sex, age, and type of stroke (cortical or subcortical) will be included as covariates because they can affect brain plasticity and BDNF response. T1 scores will also be included to increase the efficiency of the model. The influence of genotype on changes in primary and secondary outcomes in the exercise group will be inspected with the Freedman-Schatzkin test, a powerful technique to identify mediators of change that can be used in small-scale exercise studies.
Expected outcomes: Cardiovascular exercise will promote positive changes in brain excitability and will increase blood BDNF levels in individuals in the early phases of stroke recovery. However, the individual response to this type of exercise in relation to brain plasticity and BDNF levels will be influenced by the genotype of each participant.
Relevance: It is important to establish whether cardiovascular exercise enhances brain reorganization early after stroke post-stroke and whether genetic factors may influence the response to this intervention. This will provide clinicians with useful information which will be essential to design more individualized exercise-based treatments to optimize functional recovery in individuals with stroke.
Impact: The first weeks after a stroke are critical for functional recovery. After this initial period, the rate of recovery slows down and functional improvements become much more difficult to achieve. In Canada, health-care costs in the 6 months after stroke amount to $2.8 billion/year. Finding cost-effective rehabilitation strategies to promote recovery during the early phases post-stroke is essential to help patients return to an independent living.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cardiovascular training
Cardiovascular training will comprise 4 weeks of moderate-to-vigorous continuous training followed by 4 weeks of progressive high-intensity interval training (HIIT) performed on recumbent steppers. This intervention will be performed in addition to the conventional standard therapy sessions. We will start with very moderate intensities and prepare participants for higher intensities. Introducing HIIT will allow us to use higher intensities over short bursts of exercise interspersed with periods of active rest. HIIT is more effective than continuous training to increase BDNF and we have shown that even a single bout of HIIT reduces interhemispheric imbalances in excitability and improves motor learning in chronic stroke.
Cardiovascular training
8 weeks of cardiovascular training
Standard Therapy
Will comprise 8 weeks of the control protocol that includes regular sessions of physiotherapy, occupational therapy, and speech therapy.
Standard Therapy
8 weeks of Standard Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardiovascular training
8 weeks of cardiovascular training
Standard Therapy
8 weeks of Standard Therapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Who had a first-ever ischemic (cortical or subcortical) stroke confirmed by MRI/CT
* Who had stroke 2 to 6 weeks prior to participation
* With recordable motor-evoked potentials (MEPs) elicited with transcranial magnetic stimulation (TMS) from the affected hemisphere
* With no serious musculoskeletal or neurological conditions other than stroke
* With sufficient cognitive/communicative capacity to safely perform the protocols.
Exclusion Criteria
* Cognitive impairment/dysphasia affecting informed consent
* Concurrently enrolled in another exercise program
* Major psychiatric or previous neurological disease
* Absolute contraindications to TMS or exercise
40 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McGill University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marc Roig
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Roig, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jewish Rehabiliation Hospital
Laval, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
De Las Heras B, Rodrigues L, Cristini J, Yu E, Gan-Or Z, Arbour N, Thiel A, Tang A, Fung J, Eng JJ, Roig M. Investigating the Acute and Chronic Effects of Cardiovascular Exercise on Brain-Derived Neurotrophic Factor in Early Subacute Stroke. Neurorehabil Neural Repair. 2025 Aug;39(8):653-665. doi: 10.1177/15459683251342150. Epub 2025 Jun 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
199269
Identifier Type: -
Identifier Source: org_study_id