Stair Climbing Outcomes in Cardiac Rehabilitation Exercise (SCORE)
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ClinicalTrials.gov Identifier: NCT03235674 |
Recruitment Status :
Completed
First Posted : August 1, 2017
Last Update Posted : February 26, 2020
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Condition or disease | Intervention/treatment | Phase |
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Endothelial Dysfunction | Other: High-intensity stair climbing exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Feasible High Intensity Interval Exercise Training Intervention in Phase II Cardiac Rehabilitation |
Actual Study Start Date : | January 30, 2018 |
Actual Primary Completion Date : | August 8, 2019 |
Actual Study Completion Date : | September 30, 2019 |

Arm | Intervention/treatment |
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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.
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Other: High-intensity stair climbing exercise
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.
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- 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.
- 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.
- 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).
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235674
Canada, Ontario | |
Cardiac Health and Rehabilitation Centre | |
Hamilton, Ontario, Canada |
Principal Investigator: | Maureen J MacDonald, PhD | McMaster University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | McMaster University |
ClinicalTrials.gov Identifier: | NCT03235674 |
Other Study ID Numbers: |
SCORE |
First Posted: | August 1, 2017 Key Record Dates |
Last Update Posted: | February 26, 2020 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiac rehabilitation interval exercise |