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Trial record 81 of 47008 for:    intensity

Exercise Intensity Matters in Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT03614585
Recruitment Status : Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
McMaster University
Jewish Rehabilitation Hospital
Ontario Stroke Network
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marc Roig, McGill University

Brief Summary:
The main objective of this multi-site project is to compare the effects of 16 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, 16 weeks) and at 8-week follow-up (T2, 24 weeks).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: 16 weeks of high-intensity interval training Behavioral: 16 weeks of moderate-intensity continuous training Not Applicable

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 16 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 2-months 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-2, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-intensity interval training
Intensity will be determined using a percentage of the workload associated with VO2peak (pVO2peak) from the graded exercise test and ratings of perceived exertion (RPE). The protocol will involve 10 30-second intervals of high intensity interspersed with 8 60-second low-intensity intervals. The workload during the high intensity intervals will start at 70% of the pVO2peak (RPE=14-17) and progressed by 10% every 4 weeks. Low intensity intervals will be performed at 30% pVO2peak (RPE=9-11). Three-minute warm-up and 2-minute cool-down periods will be performed at 30% pVO2peak. Total HIIT time including warm-up and cool-down is 18 minutes.
Behavioral: 16 weeks of high-intensity interval training
Cardiovascular exercise

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.
Behavioral: 16 weeks of moderate-intensity continuous training
Cardiovascular exercise




Primary Outcome Measures :
  1. Cortico-spinal excitability [ Time Frame: 16 weeks ]
    Single pulse of transcranial magnetic stimulation protocol.


Secondary Outcome Measures :
  1. Intra-cortical inhibition [ Time Frame: 16 weeks ]
    Paired-pulse of transcranial magnetic stimulation protocol.

  2. Intra-cortical facilitation [ Time Frame: 16 weeks ]
    Paired-pulse of transcranial magnetic stimulation protocol.

  3. Systolic resting blood pressure [ Time Frame: 16 weeks ]
    Supine resting blood pressure.

  4. Diastolic resting blood pressure [ Time Frame: 16 weeks ]
    Supine resting blood pressure.

  5. Arterial stiffness [ Time Frame: 16 weeks ]
    Central pulse wave velocity.

  6. Cardiorespiratory fitness [ Time Frame: 16 weeks ]
    Maximum rate of oxygen consumption measured during maximum physical effort.

  7. Waist-hip ratio [ Time Frame: 16 weeks ]
    Ratio of waist circumference measured at the level of the umbilicus, and hip circumference taken at the level of the greater trochanters.


Other Outcome Measures:
  1. Enjoyment [ Time Frame: 16 weeks ]
    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.

  2. Motivation [ Time Frame: 16 weeks ]
    The Behavioral Regulation Exercise Questionnaire-2. 23 items using a 5-point Likert scale (0=Not true for me, 4=Very true for me).

  3. Gait speed [ Time Frame: 16 weeks ]
    self- and fast-paced 5-meter gait speed.

  4. Walking capacity [ Time Frame: 16 weeks ]
    6-Minute Walk Test.

  5. Motor learning [ Time Frame: 16 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-36 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614585


Contacts
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Contact: Marc Roig, PhD 514-398-4400 ext 00841 marc.roigpull@mcgill.ca
Contact: Ada Tang, PhD 905-525-9140 ext 27818 atang@mcmaster.ca

Locations
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Canada, Ontario
Ontario Central South Stroke Network Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Ada Tang, PhD    905-525-9140 ext 27818    atang@mcmaster.ca   
Contact: Jennifer Crozier, MSc       croziej@mcmaster.ca   
Canada, Quebec
Jewish Rehabiliation Hospital Not yet recruiting
Laval, Quebec, Canada, H7V 1R2
Contact: Marc Roig, PhD    450-688-9550 ext 4677    marc.roigpull@mcgill.ca   
Contact: Jean-Francois Nepveu, MSc    450-688-9550 ext 4217      
Sponsors and Collaborators
McGill University
McMaster University
Jewish Rehabilitation Hospital
Ontario Stroke Network
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Marc Roig, PhD McGill University
Principal Investigator: Ada Tang, PhD McMaster University

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Responsible Party: Marc Roig, Assistant Professor, McGill University
ClinicalTrials.gov Identifier: NCT03614585     History of Changes
Other Study ID Numbers: 388320
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be publish in peer-review journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Roig, McGill University:
Stroke
Rehabilitation
Neurosciences
Exercise
Neurorecovery
Cardiovascular health
High-intensity interval training
Moderate-intensity continuous training
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases