Clinical trial NCT03614585: Exercise Intensity Matters in Stroke Rehabilitation
Official title: Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Neurosciences
Exercise
Neurorecovery
Cardiovascular health
High-intensity interval training
Moderate-intensity continuous training
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Jewish Rehabilitation Hospital
name: Ontario Stroke Network
name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cortico-spinal excitability
timeFrame: 12 weeks
Secondary outcomes:
measure: Intra-cortical inhibition
timeFrame: 12 weeks
measure: Intra-cortical facilitation
timeFrame: 12 weeks
measure: Systolic resting blood pressure
timeFrame: 12 weeks
measure: Diastolic resting blood pressure
timeFrame: 12 weeks
measure: Arterial stiffness
timeFrame: 12 weeks
measure: Cardiorespiratory fitness
timeFrame: 12 weeks
measure: Waist-hip ratio
timeFrame: 12 weeks
Other outcomes:
measure: Enjoyment
timeFrame: 12 weeks
measure: Motivation
timeFrame: 12 weeks
measure: Gait speed
timeFrame: 12 weeks
measure: Walking capacity
timeFrame: 12 weeks
measure: Motor learning
timeFrame: 12 weeks
Locations:
city: Hamilton
country: Canada
facility: Ontario Central South Stroke Network
state: Ontario
city: Laval
country: Canada
facility: Jewish Rehabiliation Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Marc Roig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Ada Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.