Exercise and Genotype in Sub-acute Stroke

NCT05076747 | Completed

• 1 other identifier: 199269
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the impact of cardiovascular exercise on brain plasticity among patients in sub-acute stages after stroke, and whether genotype modulates the response to this intervention. Participants in the experimental group will perform cardiovascular training for 8 weeks, three times/week in addition to standard therapy, while participants in the control group will perform standard therapy only. Assessments will be performed at baseline, four weeks, and 8 weeks after training.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Neurosciences; Exercise; Neuroplasticity; BDNF; Cardiovascular training; Motor function; HIIT; Genotype

Outcome Measures

Primary Outcomes (3)

• Cortico-spinal excitability

  Single pulse motor-evoked potentials of transcranial magnetic stimulation protocol.

  8 weeks

• Intra-cortical inhibition

  Paired-pulse motor-evoked potentials of transcranial magnetic stimulation protocol.

  8 weeks

• Intra-cortical facilitation

  Paired-pulse motor-evoked potentials of transcranial magnetic stimulation protocol.

  8 weeks

Secondary Outcomes (2)

• Brain-derived neurotrophic factor

  8 weeks

• Cardiorespiratory fitness

  8 weeks

Study Arms (2)

Cardiovascular training

EXPERIMENTAL

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.

Behavioral: Cardiovascular training

Standard Therapy

ACTIVE COMPARATOR

Will comprise 8 weeks of the control protocol that includes regular sessions of physiotherapy, occupational therapy, and speech therapy.

Behavioral: Standard Therapy

Interventions

Cardiovascular training BEHAVIORAL

8 weeks of cardiovascular training

Also known as: CT

Cardiovascular training

Standard Therapy BEHAVIORAL

8 weeks of Standard Therapy

Also known as: ST

Standard Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 40-80 years old
• 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.

You may not qualify if:

• Hemorrhagic stroke
• Cognitive impairment/dysphasia affecting informed consent
• Concurrently enrolled in another exercise program
• Major psychiatric or previous neurological disease
• Absolute contraindications to TMS or exercise

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish Rehabiliation Hospital

Laval, Quebec, H7V 1R2, Canada

Location

Related Publications (1)

• 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.

  PMID: 40462267 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marc Roig, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 13, 2021
• Study Start: June 20, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 11, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)