Clinical trial NCT03235674: Stair Climbing Outcomes in Cardiac Rehabilitation Exercise
Official title: A Feasible High Intensity Interval Exercise Training Intervention in Phase II Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: Cardiac rehabilitation
interval exercise
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the effect of brief, intermittent stair climbing exercise on key cardiovascular and metabolic markers of health in individuals completing a cardiac rehabilitation program. Participants of this study will be placed into one of two exercise groups: one group will perform the standard exercise protocol currently being used by the Cardiac Health and Rehabilitation Centre at Hamilton General Hospital and the second group will perform a variation of interval exercise training, high intensity interval stair climbing.

Detailed description: Cardiac rehabilitation (CR) is a recognized health service for the secondary prevention of CVD, unfortunately, CR is vastly underutilized, due to low referral rates and patient-related factors such as time commitment, travelling distance or user fees. After 2 weeks of CR exercise prescription, \~80% of patients opt to exercise independently rather than join a structured rehabilitation program in the community, suggesting that alternatives for current centre-based CR should focus on at-home programming with the intention of enhancing adherence and maintaining the lifestyle benefits long-term. The implementation of high-intensity interval exercise in CR programming has proven to be time-effective, enjoyable, safe, and capable of inducing similar if not superior cardiorespiratory responses, when compared to traditional, continuous CR programs. Recently, the benefits of interval stair climbing exercise in sedentary women were established, in that completing 3, 60 second bouts of high intensity stair climbing, 3 days/week for 6 weeks improved cardiorespiratory fitness, and represents a model of low-volume high-intensity interval training which is tolerable, effective and easily accessible for sedentary adults.

Eligibility criteria: Inclusion Criteria:

* Men and (post-menopausal) women
* Registered to participate in the Cardiac Health and Rehabilitation Centre (CHRC) at the Hamilton Health Sciences General Division
* History of previous myocardial infarction, coronary artery bypass graft, and/or percutaneous coronary intervention
* Non-smoker (within 3-months)
* Local resident, with transportation to the CHRC at the Hamilton Health Sciences General Division.
* Ability to understand written and verbal instructions and provide written informed consent.
* Stable medical therapy.

Exclusion Criteria:

* Non-cardiac surgical procedure within two months
* Positive exercise stress test (i.e. typical symptoms of chest discomfort and ECG changes or positive nuclear scan)
* Myocardial infarction within two months; coronary artery bypass graft surgery within two months; percutaneous coronary intervention within one month
* Baseline work capacity \< 25 W
* NYHA class II-IV symptoms of heart failure
* Documented significant valve stenosis
* Symptomatic peripheral arterial disease that limits exercise capacity
* Uncontrolled supraventricular or ventricular dysrhythmia
* Unstable angina
* Uncontrolled hypertension (blood pressure \>160/90 mmHg)
* Documented chronic obstructive pulmonary disease (FEV1 \<60% and/or FVC \<60%)
* Any musculoskeletal abnormality that would limit exercise participation

Primary outcomes:
measure: brachial endothelial function as measured by flow-mediated dilation (FMD)
timeFrame: Change from baseline FMD at 12 weeks
Secondary outcomes:
measure: cardiorespiratory fitness
timeFrame: Change from baseline stress test at 12 weeks
measure: skeletal muscle capillary content
timeFrame: change from baseline capillary content at 12 weeks
measure: cardiac diastolic function
timeFrame: change from baseline left ventricular values at 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Cardiac Health and Rehabilitation Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen J MacDonald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allison MK, Baglole JH, Martin BJ, Macinnis MJ, Gurd BJ, Gibala MJ. Brief Intense Stair Climbing Improves Cardiorespiratory Fitness. Med Sci Sports Exerc. 2017 Feb;49(2):298-307. doi: 10.1249/MSS.0000000000001188.
citation: Aamot IL, Karlsen T, Dalen H, Stoylen A. Long-term Exercise Adherence After High-intensity Interval Training in Cardiac Rehabilitation: A Randomized Study. Physiother Res Int. 2016 Mar;21(1):54-64. doi: 10.1002/pri.1619. Epub 2015 Feb 16.
citation: Valentino SE, Dunford EC, Dubberley J, Lonn EM, Gibala MJ, Phillips SM, MacDonald MJ. Cardiovascular responses to high-intensity stair climbing in individuals with coronary artery disease. Physiol Rep. 2022 May;10(10):e15308. doi: 10.14814/phy2.15308.
citation: Dunford EC, Valentino SE, Dubberley J, Oikawa SY, McGlory C, Lonn E, Jung ME, Gibala MJ, Phillips SM, MacDonald MJ. Brief Vigorous Stair Climbing Effectively Improves Cardiorespiratory Fitness in Patients With Coronary Artery Disease: A Randomized Trial. Front Sports Act Living. 2021 Feb 16;3:630912. doi: 10.3389/fspor.2021.630912. eCollection 2021.
citation: Lim C, Dunford EC, Valentino SE, Oikawa SY, McGlory C, Baker SK, Macdonald MJ, Phillips SM. Both Traditional and Stair Climbing-based HIIT Cardiac Rehabilitation Induce Beneficial Muscle Adaptations. Med Sci Sports Exerc. 2021 Jun 1;53(6):1114-1124. doi: 10.1249/MSS.0000000000002573.