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Cardiovascular Effects of Acute Exercise Post-Stroke (ACES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570216
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2018
Last Update Posted : February 28, 2020
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. Cardiopulmonary exercise tests (CPETs) are used to assess cardiorespiratory fitness. Novel CPET protocols have emerged for stroke, enabling safe and valid measurements of cardiorespiratory fitness. 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 and compared the acute effects of a CPET, MICE and HIIE on arterial stiffness in stroke. This study will (1) examine the acute effects of a single session of this HIIE protocol compared to a CPET and a single session of MICE on arterial stiffness among individuals with chronic stroke, and (2) 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 in these individuals.


Condition or disease Intervention/treatment Phase
Stroke, Cardiovascular Other: Cardiopulmonary exercise test 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. Cardiopulmonary exercise tests (CPETs) are the gold standard for assessing cardiorespiratory fitness. In stroke, impairments in physical function may be present and limit individuals' ability to perform a CPET on traditional modes such as a cycle ergometer or treadmill. Thus, novel CPET protocols have been developed to allow individuals with stroke perform a fitness test safely and effectively. 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.

While the chronic effects of exercise on arterial stiffness have been examined in stroke, no study has examined the acute effects of a CPET, MICE, or HIIE. Different exercise stimuli may elicit variable short-term influences 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 HIIE session to a CPET and a session of MICE 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 the CPET and MICE, and will remain elevated following 15 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
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
All participants will perform 3 exercise sessions: one session to assess their cardiorespiratory fitness, one session on moderate-intensity continuous exercise and one session of high-intensity interval exercise
Other: Cardiopulmonary exercise test
Participants will perform a graded cardiopulmonary exercise test to asses their cardiorespiratory fitness. It will also provide a peak exercise stimulus to examine acute changes in arterial stiffness, and to prescribe both moderate intensity continuous exercise and high intensity interval exercise.

Other: Moderate-intensity continuous exercise
Participants will perform a 30-minute session of moderate-intensity continuous exercise.

Other: High-intensity interval exercise
1 week later, participants will perform a 19-minute session of high-intensity interval exercise.




Primary Outcome Measures :
  1. Change in Arterial Stiffness [ Time Frame: Resting before exercise, immediately following (within 5 minutes) of exercise cessation, and continuously for 15 minutes post exercise. ]
    Arterial stiffness will be measured at rest, immediately after each exercise stimulus, and continuously for 15 minutes after each exercise stimulus 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.


Secondary Outcome Measures :
  1. 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 HIIE and MICE

  2. 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 30-minute MICE and 19- minute HIIE protocols.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40-80 years of age
  • >6 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.

Exclusion Criteria:

  • Individuals will be excluded if they present with:
  • Significant disability (a score >2 in the modified Rankin scale)
  • 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, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03570216    
Other Study ID Numbers: 3113
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
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