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Cardiovascular Effects of Acute Exercise Post-Stroke (ACES)

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ClinicalTrials.gov Identifier: NCT03570216
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ada Tang, McMaster University

Brief Summary:

There is an urgent need to reduce the impact of stroke by promoting optimal rehabilitation strategies that decrease the risk of stroke. Improving cardiovascular health following a stroke is a key rehabilitation strategy that has the potential to reduce the risk of a recurrent event.

Adverse cardiovascular events, including stroke, are often due to chronic atherosclerosis. which shows as increased arterial stiffness. Elevated arterial stiffness is prevalent in individuals with cardiovascular disease, is associated with markers of silent cerebrovascular disease and is a new marker for predicting cardiovascular risk. Cardiovascular exercise, typically performed through moderate-intensity continuous exercise (MICE), can improve function and fitness in individuals living with stroke and lower the risk of recurrent stroke. Recently, high-intensity interval exercise (HIIE) has emerged as a potentially potent stimulus that may also lead to improvements in function and fitness. While HIIE has shown benefits in clinical and non-clinical populations, only a few small, preliminary studies have examined the effects of HIIE in individuals living with stroke, and most have primarily focused on examining the effects of HIIE on function and gait. No study has examined the acute effects of HIIE on vascular health, such as arterial stiffness. This study will examine (1) the feasibility of a high-intensity interval training exercise protocol previously found to be tolerable and effective in attaining high levels of exercise intensity in individuals with chronic stroke that were higher functioning but now applied to individuals across a broader range of functional abilities, and (2) the acute effects of a single session of this HIIE protocol compared to a single session moderate-intensity continuous exercise (MICE) protocol on arterial stiffness in these individuals.


Condition or disease Intervention/treatment Phase
Stroke, Cardiovascular Other: Moderate-intensity continuous exercise Other: High-intensity interval exercise Not Applicable

Detailed Description:

Stroke is the leading cause of adult disability and the fourth leading cause of death in Canada, with an annual cost to the economy of $3.6 billion. There is an urgent need to reduce the impact of stroke by promoting optimal rehabilitation strategies that decrease the risk of stroke.

Improving cardiovascular health following a stroke is a key rehabilitation strategy that has the potential to reduce the risk of a recurrent event. Adverse cardiovascular events, including stroke, are often due to chronic atherosclerosis. Amplified arterial stiffness is a sign of atherosclerosis which increases arterial wall stress and reduces coronary perfusion. Elevated arterial stiffness is prevalent in individuals with cardiovascular disease, is associated with markers of silent cerebrovascular disease and is a new marker for predicting cardiovascular risk.

Cardiovascular exercise, typically performed through moderate-intensity continuous exercise (MICE), can improve function and fitness in individuals living with stroke and lower the risk of recurrent stroke. Recently, high-intensity interval exercise (HIIE) has emerged as a potentially potent stimulus that may also lead to improvements in function and fitness. HIIE combines short bursts of high-intensity cardiovascular exercise with periods of rest or recovery, and allows individuals to achieve higher intensities of cardiovascular exercise that do not need to be maintained for a long period of time like MICE. In this way, HIIE has the potential to be an additional exercise strategy to enhance cardiovascular health post-stroke.

While HIIE has shown benefits in clinical and non-clinical populations, only a few small, preliminary studies have examined the effects of HIIE in individuals living with stroke, and most have primarily focused on examining the effects of HIIE on function and gait. No study has examined the acute effects of HIIE on vascular health, such as arterial stiffness. HIIE may have short-term influence on arterial stiffness in individuals who have had a stroke, but this has not been previously examined. The feasibility of HIIE for individuals with a broader range of functional abilities after stroke is also not well established.

This study will (1) compare the acute effects of a single session HIIE protocol with a single session MICE protocol on arterial stiffness and (2) examine the feasibility of a HIIE protocol in individuals with a broad range of abilities after stroke. The investigators anticipate that (1) arterial stiffness will be elevated to a greater degree immediately following HIIE compared to MICE, and will remain elevated following 45 minutes post-exercise, and (2) both HIIE and MICE protocols will be safe and feasible for individuals with stroke (no occurrence of adverse events), however the HIIE protocol will allow participants to obtain and be able to sustain a higher level of exercise intensity, and therefore a higher heart rate, compared to MICE. Understanding the time course of changes in arterial stiffness following acute exercise may provide insight into vascular responses of HIIE and thus potential underlying physiological mechanisms of post-stroke exercise.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This will be a single group prospective study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effects of High-Intensity Interval Exercise vs. Moderate-Intensity Continuous Exercise on Arterial Stiffness in Chronic Stroke
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
All participants will perform 2 exercise sessions: one session on moderate-intensity continuous exercise and one session of high-intensity interval exercise
Other: Moderate-intensity continuous exercise
Participants will perform a 35-minute session of moderate-intensity continuous exercise

Other: High-intensity interval exercise
1 week later, participants will perform a 14-minute session of high-intensity interval exercise




Primary Outcome Measures :
  1. Time spent at prescribed heart rate intensity [Feasibility] [ Time Frame: During active engagement of HIIE and MICE protocols ]
    The total time spent at the prescribed heart rate intensity for each protocol will be determined, i.e. # minutes during the 35-minute MICE protocol and 14-minute HIIE protocol


Secondary Outcome Measures :
  1. Change in Arterial Stiffness [ Time Frame: Resting before exercise, immediately following (within 5 minutes) of exercise cessation, 45 minutes post exercise. ]
    Arterial stiffness will be measured immediately after exercise session and 45 minutes after the exercise session to assess change in this measure post-acute exercise. Arterial stiffness will be measured using the criterion standard for measuring central arterial stiffness, carotid-femoral pulse wave velocity (cfPWV). Arterial stiffness will be assessed non-invasively through applanation tonometry. cfPWV is calculated as cfPWV=D (meters)/Δt (seconds), where Δt is the pulse transit time between carotid and femoral arteries and D the distance between the two arteries.

  2. Incidence of treatment-emergent adverse events [Safety] [ Time Frame: During active engagement of HIIE and MICE protocols, and within 7 days later ]
    Incidence of adverse events that occur during or after the exercise session



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50-80 years of age
  • 12-36 months following first-ever, single stroke
  • Living in the community (not in an institutional setting)
  • Able to walk at least 10 meters (assistive devices permitted)
  • Able to follow commands (a Montreal Cognitive Assessment score (MoCA) score >20).

Exclusion Criteria:

  • Individuals will be excluded if they present with:
  • Significant disability (a score <2 in the modified Rankin scale)
  • Actively engaged in concurrent stroke rehabilitation services
  • Class C or D American Heart Association Risk Scores
  • Any contraindications to exercise testing or training as set forth by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription (ACSM, 2014)
  • Any other neurological or musculoskeletal condition or co-morbidity that would preclude safe exercise participation
  • Pain worsened with exercise
  • Any cognitive, communication, or behavioral concerns that could limit safe exercise involvement

Information from the National Library of Medicine

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): NCT03570216


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Ada Tang, PhD McMaster University

Publications:
Mackay, J.& M.G., 2004. Atlas of Heart Disease and Stroke. Geneva: World Health Organization.,
ACSM, 2010. ACSM's guidelines for exercise testing and prescription 8th Edition, Philadelphia: Lippincott Williams & Wilkins.

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Responsible Party: Ada Tang, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03570216     History of Changes
Other Study ID Numbers: 3113
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ada Tang, McMaster University:
acute exercise
High-intensity interval exercise
feasibility
arterial stiffness
Additional relevant MeSH terms:
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Stroke
Myocardial Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases