Stair Climbing Outcomes in Cardiac Rehabilitation Exercise (SCORE)
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|ClinicalTrials.gov Identifier: NCT03235674|
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endothelial Dysfunction||Other: High-intensity stair climbing exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
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.
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.
- 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.
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
|Contact: Emily C Dunford, PhDfirstname.lastname@example.org|
|Contact: Maureen J MacDonald, PhDemail@example.com|
|Cardiac Health and Rehabilitation Centre||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Emily Dunford 9055172273 firstname.lastname@example.org|
|Principal Investigator:||Maureen J MacDonald, PhD||McMaster University|