Cardiovascular Effects of Acute Exercise Post-Stroke

NCT03570216 | Completed

• 1 other identifier: 3113
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cardiovascular

Keywords

acute exercise; High-intensity interval exercise; feasibility; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• 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.

  Resting before exercise, immediately following (within 5 minutes) of exercise cessation, and continuously for 15 minutes post exercise.

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events [Safety]

  During active engagement of HIIE and MICE protocols, and within 7 days later

• Time spent at prescribed heart rate intensity [Feasibility]

  During active engagement of HIIE and MICE protocols

Study Arms (1)

Exercise

EXPERIMENTAL

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; Other: Moderate-intensity continuous exercise; Other: High-intensity interval exercise

Interventions

Cardiopulmonary exercise test OTHER

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.

Exercise

Moderate-intensity continuous exercise OTHER

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

Exercise

High-intensity interval exercise OTHER

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

Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (39)

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  BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Exercise Test; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ada Tang, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a single group prospective study.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: June 26, 2018
• Study Start: March 27, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)