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临床试验/NCT03614585
NCT03614585招募中不适用

Exercise Intensity Matters: An Opportunity to Promote Neurorecovery and Cardiovascular Health in Stroke

McGill University4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
4
主要终点
Cortico-spinal excitability

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Cortico-spinal excitability

时间窗: 12 weeks

Single pulse of transcranial magnetic stimulation protocol.

次要结局

  • Diastolic resting blood pressure(12 weeks)
  • Arterial stiffness(12 weeks)
  • Intra-cortical inhibition(12 weeks)
  • Cardiorespiratory fitness(12 weeks)
  • Intra-cortical facilitation(12 weeks)
  • Systolic resting blood pressure(12 weeks)
  • Waist-hip ratio(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Roig

Assistant Professor

McGill University

研究点 (4)

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