Clinical Trials Logo

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03614585
Study type Interventional
Source McGill University
Contact Marc Roig, PhD
Phone 514-398-4400
Status Not yet recruiting
Phase N/A
Start date October 2018
Completion date March 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT03698357 - Video Balance-based Exercise in Persons With Stroke N/A
Recruiting NCT03402906 - Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke N/A
Completed NCT03575481 - Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Recruiting NCT03542188 - TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment N/A
Completed NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
Active, not recruiting NCT03371290 - Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke N/A
Recruiting NCT03884621 - Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China N/A
Recruiting NCT03294187 - Encouragement-induced Movement Therapy in Daily Life N/A
Enrolling by invitation NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT01996137 - VASSTII: An Exploratory Clinical Study on a VASST IITreadmill System for Post Stroke Gait Rehabilitation. N/A
Completed NCT03559829 - Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A