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Trial record 81 of 46538 for:    intensity

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

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date March 13, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03570216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Effects of Acute Exercise Post-Stroke
Official Title  ICMJE Acute Effects of High-Intensity Interval Exercise vs. Moderate-Intensity Continuous Exercise on Arterial Stiffness in Chronic Stroke
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This will be a single group prospective study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke, Cardiovascular
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Exercise
All participants will perform 2 exercise sessions: one session on moderate-intensity continuous exercise and one session of high-intensity interval exercise
Interventions:
  • Other: Moderate-intensity continuous exercise
  • Other: High-intensity interval exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 25, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03570216
Other Study ID Numbers  ICMJE 3113
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ada Tang, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ada Tang, PhD McMaster University
PRS Account McMaster University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP