- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03235674
Stair Climbing Outcomes in Cardiac Rehabilitation Exercise (SCORE)
February 25, 2020 updated by: McMaster University
A Feasible High Intensity Interval Exercise Training Intervention in Phase II Cardiac Rehabilitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Cardiac Health and Rehabilitation Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-intensity stair climbing exercise
3 x 60 seconds of stair climbing, at a vigorous pace as described by rating of perceived exertion, separated by 60 seconds of rest.
Subjects will complete supervised sessions 3 times/week for 2 weeks, and then continue unsupervised for the following 10 weeks.
|
High intensity stair climbing exercise at a vigorous pace as measured by rating of perceived exertion.
|
NO_INTERVENTION: standard cardiac rehabilitation exercise
Subjects will complete the traditional cardiac rehabilitation program, combination of aerobic and resistance exercise 2 times/week for 2 weeks, and then continue unsupervised for the following 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
brachial endothelial function as measured by flow-mediated dilation (FMD)
Time Frame: Change from baseline FMD at 12 weeks
|
This technique involves the placement of a blood pressure cuff around the forearm distal to the olecranon process (elbow).
The cuff is inflated above systolic blood pressure to ~200 mmHg (in order to attain cessation of arm blood flow) and is held at this pressure for a period of five minutes.
Continual measures of brachial artery diameter and blood flow velocity will be obtained using Doppler ultrasound.
A 10 MHz probe will be placed on the upper arm (below the biceps) and moved around until the best signal is found.
Images of brachial artery diameter and blood flow velocity will be taken at rest (before cuff inflation), prior to cuff deflation (end of five minute ischemic period), and following cuff deflation for two minutes.
|
Change from baseline FMD at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiorespiratory fitness
Time Frame: Change from baseline stress test at 12 weeks
|
Maximal aerobic capacity will be determined using a medically monitored exercise stress test.
|
Change from baseline stress test at 12 weeks
|
skeletal muscle capillary content
Time Frame: change from baseline capillary content at 12 weeks
|
Muscle capillaries will be detected in frozen cross-sections of muscle biopsies based on positive staining with fluorescent lectin Ulex europaeus, and quantified relative to muscle fibre number (capillary:fibre ratio).
|
change from baseline capillary content at 12 weeks
|
cardiac diastolic function
Time Frame: change from baseline left ventricular values at 12 weeks
|
The heart must be imaged at both the base (top) and apex (bottom) of the left ventricle.
Images will be taken in the parasternal short axis view with the participant lying in the left lateral decubitus position to allow the expansion of the rib cage and proper orientation of the heart within the chest cavity.
Doppler ultrasound (5MHz sector probe) will be applied to the upper-middle section of the chest for the best images.
Basal images will be taken at the tips of the mitral valves, while apical images will be taken at the most distal aspect of the left ventricle, with the LV cavity representing ~50% of the left ventricle wall thickness.
|
change from baseline left ventricular values at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Med Sci Sports Exerc. 2017 Mar;49(3):626.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 30, 2018
Primary Completion (ACTUAL)
August 8, 2019
Study Completion (ACTUAL)
September 30, 2019
Study Registration Dates
First Submitted
June 9, 2017
First Submitted That Met QC Criteria
July 30, 2017
First Posted (ACTUAL)
August 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SCORE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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