Stroke, CardiovascularACESNCT03570216
Cardiovascular Effects of Acute Exercise Post-Stroke
A study testing Cardiopulmonary exercise test, Moderate-intensity continuous exercise and High-intensity interval exercise in people with Stroke, Cardiovascular, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- Cardiopulmonary exercise test, Moderate-intensity continuous exercise and High-intensity interval exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of High-Intensity Interval Exercise vs. Moderate-Intensity Continuous Exercise on Arterial Stiffness in Chronic Stroke
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.
Read the 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.
- Conditions
- Stroke, Cardiovascular
- Being tested
- Cardiopulmonary exercise test, Moderate-intensity continuous exercise, High-intensity interval exercise
- Keywords
- acute exercise, High-intensity interval exercise, feasibility, arterial stiffness
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
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.
Moderate-intensity continuous exerciseOther
Participants will perform a 30-minute session of moderate-intensity continuous exercise.
High-intensity interval exerciseOther
1 week later, participants will perform a 19-minute session of high-intensity interval exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cardiopulmonary exercise test; Other: Moderate-intensity continuous exercise; Other: High-intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Incidence of adverse events that occur during or after HIIE and MICE
Measured: During active engagement of HIIE and MICE protocols, and within 7 days later
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.
Measured: During active engagement of HIIE and MICE protocols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start27 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a single group prospective study.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Tang, McMaster University
- Investigators
- Ada Tang, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570216
- Sponsor's protocol ID
- 3113
- Acronym
- ACES
- Status last verified
- Feb 2021
- First submitted
- 26 Mar 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
PubMed 25333969Attina TM, Drummond ID, Malatino LS, Maxwell SR, Webb DJ. Phosphodiesterase type 5 inhibition improves arterial stiffness after exercise but not exercise capacity in hypertensive men. Am J Hypertens. 2013 Mar;26(3):342-50. doi: 10.1093/ajh/hps057. Epub 2013 Jan 7.
PubMed 23382484Baert I, Daly D, Dejaeger E, Vanroy C, Vanlandewijck Y, Feys H. Evolution of cardiorespiratory fitness after stroke: a 1-year follow-up study. Influence of prestroke patients' characteristics and stroke-related factors. Arch Phys Med Rehabil. 2012 Apr;93(4):669-76. doi: 10.1016/j.apmr.2011.09.022. Epub 2012 Feb 13.
PubMed 22336102Barodka VM, Joshi BL, Berkowitz DE, Hogue CW Jr, Nyhan D. Review article: implications of vascular aging. Anesth Analg. 2011 May;112(5):1048-60. doi: 10.1213/ANE.0b013e3182147e3c. Epub 2011 Apr 7.
PubMed 21474663Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen CH, Cruickshank JK, Hwang SJ, Lakatta EG, Laurent S, Maldonado J, Mitchell GF, Najjar SS, Newman AB, Ohishi M, Pannier B, Pereira T, Vasan RS, Shokawa T, Sutton-Tyrell K, Verbeke F, Wang KL, Webb DJ, Willum Hansen T, Zoungas S, McEniery CM, Cockcroft JR, Wilkinson IB. Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol. 2014 Feb 25;63(7):636-646. doi: 10.1016/j.jacc.2013.09.063. Epub 2013 Nov 13.
PubMed 24239664Billinger SA, Boyne P, Coughenour E, Dunning K, Mattlage A. Does aerobic exercise and the FITT principle fit into stroke recovery? Curr Neurol Neurosci Rep. 2015;15(2):519. doi: 10.1007/s11910-014-0519-8.
PubMed 25475494Billinger SA, Coughenour E, Mackay-Lyons MJ, Ivey FM. Reduced cardiorespiratory fitness after stroke: biological consequences and exercise-induced adaptations. Stroke Res Treat. 2012;2012:959120. doi: 10.1155/2012/959120. Epub 2011 Aug 14.
PubMed 21876848Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Rockwell B, Keeton G, Westover J, Williams A, McCarthy M, Kissela B. High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Phys Ther. 2016 Oct;96(10):1533-1544. doi: 10.2522/ptj.20150277. Epub 2016 Apr 21.
PubMed 27103222Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Kissela B. Within-session responses to high-intensity interval training in chronic stroke. Med Sci Sports Exerc. 2015 Mar;47(3):476-84. doi: 10.1249/MSS.0000000000000427.
PubMed 24977698Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
PubMed 2749846Chen Y, Shen F, Liu J, Yang GY. Arterial stiffness and stroke: de-stiffening strategy, a therapeutic target for stroke. Stroke Vasc Neurol. 2017 Mar 17;2(2):65-72. doi: 10.1136/svn-2016-000045. eCollection 2017 Jun.
PubMed 28959494Cohn JN. Arterial stiffness, vascular disease, and risk of cardiovascular events. Circulation. 2006 Feb 7;113(5):601-3. doi: 10.1161/CIRCULATIONAHA.105.600866. No abstract available.
PubMed 16461830Eng JJ, Dawson AS, Chu KS. Submaximal exercise in persons with stroke: test-retest reliability and concurrent validity with maximal oxygen consumption. Arch Phys Med Rehabil. 2004 Jan;85(1):113-8. doi: 10.1016/s0003-9993(03)00436-2.
PubMed 14970978Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
PubMed 15788341Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.
PubMed 22289907
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of High-Intensity Interval Exercise vs. Moderate-Intensity Continuous Exercise on Arterial Stiffness in Chronic Stroke
- ClinicalTrials.gov ID
- NCT03570216
- Acronym / sponsor ID
- ACES / 3113
- Conditions
- Stroke, Cardiovascular
- Keywords
- acute exercise, High-intensity interval exercise, feasibility, arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a single group prospective study.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Cardiopulmonary exercise test, Other: Moderate-intensity continuous exercise, Other: High-intensity interval exerciseAll 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testParticipants 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 | Exercise |
| Moderate-intensity continuous exerciseParticipants will perform a 30-minute session of moderate-intensity continuous exercise. | Other | Exercise |
| High-intensity interval exercise1 week later, participants will perform a 19-minute session of high-intensity interval exercise. | Other | Exercise |
Primary outcome
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.
2 secondary outcomes
Incidence of treatment-emergent adverse events [Safety]
Time frame: During active engagement of HIIE and MICE protocols, and within 7 days later
Time spent at prescribed heart rate intensity [Feasibility]
Time frame: During active engagement of HIIE and MICE protocols
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 25333969Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
- Background: PubMed 23382484Attina TM, Drummond ID, Malatino LS, Maxwell SR, Webb DJ. Phosphodiesterase type 5 inhibition improves arterial stiffness after exercise but not exercise capacity in hypertensive men. Am J Hypertens. 2013 Mar;26(3):342-50. doi: 10.1093/ajh/hps057. Epub 2013 Jan 7.
- Background: PubMed 22336102Baert I, Daly D, Dejaeger E, Vanroy C, Vanlandewijck Y, Feys H. Evolution of cardiorespiratory fitness after stroke: a 1-year follow-up study. Influence of prestroke patients' characteristics and stroke-related factors. Arch Phys Med Rehabil. 2012 Apr;93(4):669-76. doi: 10.1016/j.apmr.2011.09.022. Epub 2012 Feb 13.
- Background: PubMed 21474663Barodka VM, Joshi BL, Berkowitz DE, Hogue CW Jr, Nyhan D. Review article: implications of vascular aging. Anesth Analg. 2011 May;112(5):1048-60. doi: 10.1213/ANE.0b013e3182147e3c. Epub 2011 Apr 7.
- Background: PubMed 24239664Ben-Shlomo Y, Spears M, Boustred C, May M, Anderson SG, Benjamin EJ, Boutouyrie P, Cameron J, Chen CH, Cruickshank JK, Hwang SJ, Lakatta EG, Laurent S, Maldonado J, Mitchell GF, Najjar SS, Newman AB, Ohishi M, Pannier B, Pereira T, Vasan RS, Shokawa T, Sutton-Tyrell K, Verbeke F, Wang KL, Webb DJ, Willum Hansen T, Zoungas S, McEniery CM, Cockcroft JR, Wilkinson IB. Aortic pulse wave velocity improves cardiovascular event prediction: an individual participant meta-analysis of prospective observational data from 17,635 subjects. J Am Coll Cardiol. 2014 Feb 25;63(7):636-646. doi: 10.1016/j.jacc.2013.09.063. Epub 2013 Nov 13.
- Background: PubMed 25475494Billinger SA, Boyne P, Coughenour E, Dunning K, Mattlage A. Does aerobic exercise and the FITT principle fit into stroke recovery? Curr Neurol Neurosci Rep. 2015;15(2):519. doi: 10.1007/s11910-014-0519-8.
- Background: PubMed 21876848Billinger SA, Coughenour E, Mackay-Lyons MJ, Ivey FM. Reduced cardiorespiratory fitness after stroke: biological consequences and exercise-induced adaptations. Stroke Res Treat. 2012;2012:959120. doi: 10.1155/2012/959120. Epub 2011 Aug 14.
- Background: PubMed 27103222Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Rockwell B, Keeton G, Westover J, Williams A, McCarthy M, Kissela B. High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Phys Ther. 2016 Oct;96(10):1533-1544. doi: 10.2522/ptj.20150277. Epub 2016 Apr 21.
- Background: PubMed 24977698Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Kissela B. Within-session responses to high-intensity interval training in chronic stroke. Med Sci Sports Exerc. 2015 Mar;47(3):476-84. doi: 10.1249/MSS.0000000000000427.
- Background: PubMed 2749846Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
- Background: PubMed 28959494Chen Y, Shen F, Liu J, Yang GY. Arterial stiffness and stroke: de-stiffening strategy, a therapeutic target for stroke. Stroke Vasc Neurol. 2017 Mar 17;2(2):65-72. doi: 10.1136/svn-2016-000045. eCollection 2017 Jun.
- Background: PubMed 16461830Cohn JN. Arterial stiffness, vascular disease, and risk of cardiovascular events. Circulation. 2006 Feb 7;113(5):601-3. doi: 10.1161/CIRCULATIONAHA.105.600866. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ada Tang, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary exercise test, Moderate-intensity continuous exercise and High-intensity interval exercise in people with Stroke, Cardiovascular, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arterial Stiffness (time frame: Resting before exercise, immediately following (within 5 minutes) of exercise cessation, and continuously for 15 minutes post exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570216, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.