Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03614585 |
Other study ID # |
388320 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
December 2024 |
Study information
Verified date |
October 2023 |
Source |
McGill University |
Contact |
Marc Roig, PhD |
Phone |
514-398-4400 |
Email |
marc.roigpull[@]mcgill.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
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.