Exercise Intensity Matters in Stroke Rehabilitation

NCT03614585 | Unknown

• 1 other identifier: 388320
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this multi-site project is to compare the effects of 12 weeks of HIIT vs. MICT on brain plasticity. The effects of HIIT vs. MICT on cardiovascular health, psychosocial predictors of physical activity and motor function will also be compared. HIIT and MICT will be delivered through a whole-body exercise paradigm using a recumbent stepper that requires arm and leg forces. Outcomes will be assessed at baseline (T0, 0 weeks), at the end of the intervention (T1, 12 weeks) and at 8-week follow-up (T2, 20 weeks).

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Neurosciences; Exercise; Neurorecovery; Cardiovascular health; High-intensity interval training; Moderate-intensity continuous training

Outcome Measures

Primary Outcomes (1)

• Cortico-spinal excitability

  Single pulse of transcranial magnetic stimulation protocol.

  12 weeks

Secondary Outcomes (7)

• Intra-cortical inhibition

  12 weeks

• Intra-cortical facilitation

  12 weeks

• Systolic resting blood pressure

  12 weeks

• Diastolic resting blood pressure

  12 weeks

• Arterial stiffness

  12 weeks

Other Outcomes (5)

• Enjoyment

  12 weeks

• Motivation

  12 weeks

• Gait speed

  12 weeks

Study Arms (2)

High-intensity interval training

EXPERIMENTAL

Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= \[max HR - resting HR\] x \[% training\] + \[resting HR\]) and ratings of perceived exertion (RPE). The protocol will involve 10 60-second intervals of high intensity interspersed with 9 60-second low-intensity intervals. The initial high intensity intervals will start at 80% of the HRR (RPE=14-17) and progress by 10% every 4 weeks. Low intensity intervals will be performed at 30% of HRR (RPE=9-11). Three-minute warm-up and 2-minute cool-down periods will be performed at 30% of HRR. Total HIIT time including warm-up and cool-down is 24 minutes.

Behavioral: 12 weeks of High-intensity Interval Training

Moderate-intensity continuous training

EXPERIMENTAL

Intensity will be determined using a combination of heart rate reserve (HRR, calculated as HRR= \[max HR - resting HR\] x \[% training\] + \[resting HR\]) and ratings of perceived exertion (RPE). The MICT protocol will be increased using a progression schedule previously used (initial intensity at 40% HRR (RPE=9-11), and progressed by 10% HRR every 4 weeks up to 60% HRR (RPE=13-14) will be maintained until the end of the intervention). A 3-minute warm-up and 2-minute cool-down will be performed at 30% HRR (RPE=9-11). The total duration of MICT, including warm-up and cool-down, will be 35 minutes.

Behavioral: 12 weeks of Moderate-Intensity Continuous Training

Interventions

12 weeks of High-intensity Interval Training BEHAVIORAL

Cardiovascular exercise

High-intensity interval training

12 weeks of Moderate-Intensity Continuous Training BEHAVIORAL

Cardiovascular exercise

Moderate-intensity continuous training

Eligibility Criteria

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

You may qualify if:

• months following first-ever, single stroke confirmed by MRI/CT
• Living in the community and able to independently walk at least 10 meters (assistive devices permitted, as this is representative of many people who regain some walking ability following stroke but commonly with some adaptation)
• Montreal Cognitive Assessment score \>20 (individuals with this score are capable to follow exercise instructions)

You may not qualify if:

• Significant disability as determined by modified Rankin scale score \<2
• Stroke of non-cardiogenic origin or tumor
• Actively engaged in stroke rehabilitation services or a structured exercise program besides the one provided in the study
• Class C or D American Heart Association Risk Criteria
• Other neurological or musculoskeletal co-morbidities that preclude exercise participation
• Pain which is worsened with exercise
• Cognitive, communication, or behavioral issues that would limit safe exercise participation
• Contraindications to transcranial magnetic stimulation.

Sponsors & Collaborators

• McGill University: lead
• McMaster University: collaborator
• Jewish Rehabilitation Hospital: collaborator
• Ontario Stroke Network: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Ontario Central South Stroke Network

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Jewish Rehabiliation Hospital

Laval, Quebec, H7V 1R2, Canada

RECRUITING

Related Publications (3)

• Rodrigues L, Moncion K, Angelopoulos SA, Heras BL, Sweet S, Eng JJ, Fung J, MacKay-Lyons M, Tang A, Roig M. Psychosocial Responses to a Cardiovascular Exercise Randomized Controlled Trial: Does Intensity Matter for Individuals Post-stroke? Arch Phys Med Rehabil. 2025 Jun;106(6):828-836. doi: 10.1016/j.apmr.2025.01.468. Epub 2025 Jan 31.

  PMID: 39894292 DERIVED

• Moncion K, Rodrigues L, De Las Heras B, Noguchi KS, Wiley E, Eng JJ, MacKay-Lyons M, Sweet SN, Thiel A, Fung J, Stratford P, Richardson JA, MacDonald MJ, Roig M, Tang A. Cardiorespiratory Fitness Benefits of High-Intensity Interval Training After Stroke: A Randomized Controlled Trial. Stroke. 2024 Sep;55(9):2202-2211. doi: 10.1161/STROKEAHA.124.046564. Epub 2024 Aug 7.

  PMID: 39113181 DERIVED

• Rodrigues L, Moncion K, Eng JJ, Noguchi KS, Wiley E, de Las Heras B, Sweet SN, Fung J, MacKay-Lyons M, Nelson AJ, Medeiros D, Crozier J, Thiel A, Tang A, Roig M. Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke. Trials. 2022 May 24;23(1):442. doi: 10.1186/s13063-022-06359-w.

  PMID: 35610659 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marc Roig, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Ada Tang, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Roig, PhD

CONTACT

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

Ada Tang, PhD

CONTACT

905-525-9140; atang@mcmaster.ca

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: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 3, 2018
• Study Start: January 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)