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Cardiovascular Effects of Acute Exercise Post-Stroke (ACES)

Primary Purpose

Stroke, Cardiovascular

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiopulmonary exercise test
Moderate-intensity continuous exercise
High-intensity interval exercise
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Cardiovascular focused on measuring acute exercise, High-intensity interval exercise, feasibility, arterial stiffness

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Arterial Stiffness
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

Incidence of treatment-emergent adverse events [Safety]
Incidence of adverse events that occur during or after HIIE and MICE
Time spent at prescribed heart rate intensity [Feasibility]
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.

Full Information

First Posted
March 26, 2018
Last Updated
February 25, 2021
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03570216
Brief Title
Cardiovascular Effects of Acute Exercise Post-Stroke
Acronym
ACES
Official Title
Acute Effects of High-Intensity Interval Exercise vs. Moderate-Intensity Continuous Exercise on Arterial Stiffness in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular
Keywords
acute exercise, High-intensity interval exercise, feasibility, arterial stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a single group prospective study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary exercise test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate-intensity continuous exercise
Intervention Description
Participants will perform a 30-minute session of moderate-intensity continuous exercise.
Intervention Type
Other
Intervention Name(s)
High-intensity interval exercise
Intervention Description
1 week later, participants will perform a 19-minute session of high-intensity interval exercise.
Primary Outcome Measure Information:
Title
Change in Arterial Stiffness
Description
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.
Time Frame
Resting before exercise, immediately following (within 5 minutes) of exercise cessation, and continuously for 15 minutes post exercise.
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events [Safety]
Description
Incidence of adverse events that occur during or after HIIE and MICE
Time Frame
During active engagement of HIIE and MICE protocols, and within 7 days later
Title
Time spent at prescribed heart rate intensity [Feasibility]
Description
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.
Time Frame
During active engagement of HIIE and MICE protocols

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Cardiovascular Effects of Acute Exercise Post-Stroke

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