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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- Cortico-spinal excitability [ Time Frame: 16 weeks ]Single pulse of transcranial magnetic stimulation protocol.
- Intra-cortical inhibition [ Time Frame: 16 weeks ]Paired-pulse of transcranial magnetic stimulation protocol.
- Intra-cortical facilitation [ Time Frame: 16 weeks ]Paired-pulse of transcranial magnetic stimulation protocol.
- Systolic resting blood pressure [ Time Frame: 16 weeks ]Supine resting blood pressure.
- Diastolic resting blood pressure [ Time Frame: 16 weeks ]Supine resting blood pressure.
- Arterial stiffness [ Time Frame: 16 weeks ]Central pulse wave velocity.
- Cardiorespiratory fitness [ Time Frame: 16 weeks ]Maximum rate of oxygen consumption measured during maximum physical effort.
- 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.
- 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.
- 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).
- Gait speed [ Time Frame: 16 weeks ]self- and fast-paced 5-meter gait speed.
- Walking capacity [ Time Frame: 16 weeks ]6-Minute Walk Test.
- 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.
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
|Contact: Marc Roig, PhD||514-398-4400 ext firstname.lastname@example.org|
|Contact: Ada Tang, PhD||905-525-9140 ext email@example.com|
|Ontario Central South Stroke Network||Not yet recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Ada Tang, PhD 905-525-9140 ext 27818 firstname.lastname@example.org|
|Contact: Jennifer Crozier, MSc email@example.com|
|Jewish Rehabiliation Hospital||Not yet recruiting|
|Laval, Quebec, Canada, H7V 1R2|
|Contact: Marc Roig, PhD 450-688-9550 ext 4677 firstname.lastname@example.org|
|Contact: Jean-Francois Nepveu, MSc 450-688-9550 ext 4217|
|Principal Investigator:||Marc Roig, PhD||McGill University|
|Principal Investigator:||Ada Tang, PhD||McMaster University|