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Exercise Intensity Matters in Stroke Rehabilitation

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
12 weeks of High-intensity Interval Training
12 weeks of Moderate-Intensity Continuous Training
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Neurosciences, Exercise, Neurorecovery, Cardiovascular health, High-intensity interval training, Moderate-intensity continuous training

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ontario Central South Stroke NetworkRecruiting
  • Jewish Rehabiliation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-intensity interval training

Moderate-intensity continuous training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cortico-spinal excitability
Single pulse of transcranial magnetic stimulation protocol.

Secondary Outcome Measures

Intra-cortical inhibition
Paired-pulse of transcranial magnetic stimulation protocol.
Intra-cortical facilitation
Paired-pulse of transcranial magnetic stimulation protocol.
Systolic resting blood pressure
Supine resting blood pressure.
Diastolic resting blood pressure
Supine resting blood pressure.
Arterial stiffness
Central pulse wave velocity.
Cardiorespiratory fitness
Maximum rate of oxygen consumption measured during maximum physical effort.
Waist-hip ratio
Ratio of waist circumference measured at the level of the umbilicus, and hip circumference taken at the level of the greater trochanters.

Full Information

First Posted
July 26, 2018
Last Updated
October 17, 2023
Sponsor
McGill University
Collaborators
McMaster University, Jewish Rehabilitation Hospital, Ontario Stroke Network, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03614585
Brief Title
Exercise Intensity Matters in Stroke Rehabilitation
Official Title
Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
McMaster University, Jewish Rehabilitation Hospital, Ontario Stroke Network, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Background: Stroke is a major health issue in Canada, with 405,000 Canadians currently living with stroke. Exercise is an important component of stroke rehabilitation that can result in improved function and health. Traditionally, exercise rehabilitation programs for stroke employ moderate-intensity continuous training (MICT) protocols that are typically sustained for 20-30 minutes. The continuous nature of this form of training however, even at moderate intensities, is challenging for many individuals with stroke to sustain due to neuromotor impairments and poor exercise capacity. High-intensity exercise, when delivered in short interval bursts (i.e. high-intensity interval training, HIIT), may be a feasible alternative that allows higher intensities to be achieved during exercise. This is important because intensity of training is the critical factor in promoting changes in neuroplasticity and cardiovascular health, the two most important aspects of recovery and secondary prevention after stroke. Interventions implemented earlier following stroke are generally viewed to yield greater benefits, but high intensity exercise may also promote neuroplasticity and optimize cardiovascular health in later stages of recovery. Furthermore, determining if HIIT is viewed to be motivating and enjoyable for individuals post-stroke can provide insight into the sustainability of this intervention. Objective: To compare the effects of 12 weeks of HIIT and MICT on neuroplasticity, cardiovascular health and psychosocial predictors of physical activity in individuals with chronic stroke. Design: Participants will be recruited from two research sites and randomly allocated into HIIT or MICT. Participants will be assessed before and after the training period, and at an 8-week follow-up. Outcomes: 1) The investigators will assess: Neuroplasticity: by measuring markers of corticospinal excitability at rest and in response to a non-invasive brain stimulation protocol applied over the primary motor cortex (M1); 2) Cardiovascular health: by measuring cardiorespiratory fitness, resting blood pressure, arterial stiffness, and waist-hip ratio; 3) Psychosocial predictors of physical activity: by measuring exercise motivation and enjoyment. Methods: Neuroplasticity: motor evoked potentials amplitude, intracortical facilitation and short-intracortical inhibition on the lesioned and unlesioned upper limb M1 area at rest and in response to continuous theta-burst will be measured with transcranial magnetic stimulation; Cardiovascular health: cardiorespiratory fitness will be measured with a graded exercise test, resting blood pressure with an automated blood pressure monitor and arterial stiffness using applanation tonometry. Exercise motivation and enjoyment will be assessed with the Physical Activity Enjoyment Scale and the Behavioral Regulation Exercise Questionnaire-3, respectively. Expected results: Both HIIT and MICT will result in improvements in outcomes of neuroplasticity and cardiovascular health. However, improvements with HIIT will be greater and will last longer. Participants will rate HIIT as enjoyable as MICT, and motivation for exercise will increase similarly after both interventions. Impact: HIIT is a promising, time-efficient, and potentially more effective alternative to traditional MICT protocols that could offer an opportunity for greater improvement in motor recovery and cardiovascular health in people living with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Neurosciences, Exercise, Neurorecovery, Cardiovascular health, High-intensity interval training, Moderate-intensity continuous training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate-intensity continuous training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12 weeks of High-intensity Interval Training
Intervention Description
Cardiovascular exercise
Intervention Type
Behavioral
Intervention Name(s)
12 weeks of Moderate-Intensity Continuous Training
Intervention Description
Cardiovascular exercise
Primary Outcome Measure Information:
Title
Cortico-spinal excitability
Description
Single pulse of transcranial magnetic stimulation protocol.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Intra-cortical inhibition
Description
Paired-pulse of transcranial magnetic stimulation protocol.
Time Frame
12 weeks
Title
Intra-cortical facilitation
Description
Paired-pulse of transcranial magnetic stimulation protocol.
Time Frame
12 weeks
Title
Systolic resting blood pressure
Description
Supine resting blood pressure.
Time Frame
12 weeks
Title
Diastolic resting blood pressure
Description
Supine resting blood pressure.
Time Frame
12 weeks
Title
Arterial stiffness
Description
Central pulse wave velocity.
Time Frame
12 weeks
Title
Cardiorespiratory fitness
Description
Maximum rate of oxygen consumption measured during maximum physical effort.
Time Frame
12 weeks
Title
Waist-hip ratio
Description
Ratio of waist circumference measured at the level of the umbilicus, and hip circumference taken at the level of the greater trochanters.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Enjoyment
Description
The Physical Activity Enjoyment Scale. Each item is scored 1-7 (1=does not make me happy, 7=makes me happy), yielding a total between 8 and 56.
Time Frame
12 weeks
Title
Motivation
Description
The Behavioral Regulation Exercise Questionnaire-3. 24 items using a 5-point Likert scale (0=Not true for me, 4=Very true for me).
Time Frame
12 weeks
Title
Gait speed
Description
self- and fast-paced 6-meter gait speed.
Time Frame
12 weeks
Title
Walking capacity
Description
6-Minute Walk Test.
Time Frame
12 weeks
Title
Motor learning
Description
A motor task that requires modulating hand-grasping force. The goal is to apply force, move the cursor, and reach targets displayed on the screen as accurately as possible.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Roig, PhD
Phone
514-398-4400
Ext
00841
Email
marc.roigpull@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ada Tang, PhD
Phone
905-525-9140
Ext
27818
Email
atang@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Roig, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ontario Central South Stroke Network
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Phone
905-525-9140
Ext
27818
Email
atang@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Jennifer Crozier, MSc
Email
croziej@mcmaster.ca
Facility Name
Jewish Rehabiliation Hospital
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 1R2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Roig, PhD
Phone
450-688-9550
Ext
4677
Email
marc.roigpull@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Jean-Francois Nepveu, MSc
Phone
450-688-9550
Ext
4217

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be publish in peer-review journals.
Citations:
PubMed Identifier
35610659
Citation
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.
Results Reference
derived

Learn more about this trial

Exercise Intensity Matters in Stroke Rehabilitation

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