Recruiting

Exercise Intensity

Sponsor:

McGill University

Code:

NCT03614585

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

12 weeks of High-intensity Interval Training

12 weeks of Moderate-Intensity Continuous Training

Study Details

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

Study ID

NCT03614585

Start date

Jan 1, 2020

Status verified date

Oct, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 6-60 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)

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-intensity interval training

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.

experimental: Moderate-intensity continuous training

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.

Interventions

12 weeks of High-intensity Interval Training

Cardiovascular exercise

12 weeks of Moderate-Intensity Continuous Training

Cardiovascular exercise

Primary outcome measure

  • Cortico-spinal excitability [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Marc Roig, PhD

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

Ada Tang, PhD

905-525-9140atang@mcmaster.ca

Locations

Ontario Central South Stroke Network

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Ada Tang, PhD

905-525-9140atang@mcmaster.ca

Jennifer Crozier, MSc

croziej@mcmaster.ca

Jewish Rehabiliation Hospital

Recruiting

Laval, Quebec, Canada, H7V 1R2

Contacts

Marc Roig, PhD

450-688-9550marc.roigpull@mcgill.ca

Jean-Francois Nepveu, MSc

450-688-9550

More Information

Sponsor

McGill University

Last update posted

Oct 19, 2023

Last verified

Oct, 2023

Keywords

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

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 2023-10-19.