<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235674</url>
  </required_header>
  <id_info>
    <org_study_id>SCORE</org_study_id>
    <nct_id>NCT03235674</nct_id>
  </id_info>
  <brief_title>Stair Climbing Outcomes in Cardiac Rehabilitation Exercise</brief_title>
  <acronym>SCORE</acronym>
  <official_title>A Feasible High Intensity Interval Exercise Training Intervention in Phase II Cardiac Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effect of brief, intermittent stair climbing exercise on key&#xD;
      cardiovascular and metabolic markers of health in individuals completing a cardiac&#xD;
      rehabilitation program. Participants of this study will be placed into one of two exercise&#xD;
      groups: one group will perform the standard exercise protocol currently being used by the&#xD;
      Cardiac Health and Rehabilitation Centre at Hamilton General Hospital and the second group&#xD;
      will perform a variation of interval exercise training, high intensity interval stair&#xD;
      climbing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac rehabilitation (CR) is a recognized health service for the secondary prevention of&#xD;
      CVD, unfortunately, CR is vastly underutilized, due to low referral rates and patient-related&#xD;
      factors such as time commitment, travelling distance or user fees. After 2 weeks of CR&#xD;
      exercise prescription, ~80% of patients opt to exercise independently rather than join a&#xD;
      structured rehabilitation program in the community, suggesting that alternatives for current&#xD;
      centre-based CR should focus on at-home programming with the intention of enhancing adherence&#xD;
      and maintaining the lifestyle benefits long-term. The implementation of high-intensity&#xD;
      interval exercise in CR programming has proven to be time-effective, enjoyable, safe, and&#xD;
      capable of inducing similar if not superior cardiorespiratory responses, when compared to&#xD;
      traditional, continuous CR programs. Recently, the benefits of interval stair climbing&#xD;
      exercise in sedentary women were established, in that completing 3, 60 second bouts of high&#xD;
      intensity stair climbing, 3 days/week for 6 weeks improved cardiorespiratory fitness, and&#xD;
      represents a model of low-volume high-intensity interval training which is tolerable,&#xD;
      effective and easily accessible for sedentary adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>brachial endothelial function as measured by flow-mediated dilation (FMD)</measure>
    <time_frame>Change from baseline FMD at 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cardiorespiratory fitness</measure>
    <time_frame>Change from baseline stress test at 12 weeks</time_frame>
    <description>Maximal aerobic capacity will be determined using a medically monitored exercise stress test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skeletal muscle capillary content</measure>
    <time_frame>change from baseline capillary content at 12 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac diastolic function</measure>
    <time_frame>change from baseline left ventricular values at 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>High-intensity stair climbing exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard cardiac rehabilitation exercise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity stair climbing exercise</intervention_name>
    <description>High intensity stair climbing exercise at a vigorous pace as measured by rating of perceived exertion.</description>
    <arm_group_label>High-intensity stair climbing exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and (post-menopausal) women&#xD;
&#xD;
          -  Registered to participate in the Cardiac Health and Rehabilitation Centre (CHRC) at&#xD;
             the Hamilton Health Sciences General Division&#xD;
&#xD;
          -  History of previous myocardial infarction, coronary artery bypass graft, and/or&#xD;
             percutaneous coronary intervention&#xD;
&#xD;
          -  Non-smoker (within 3-months)&#xD;
&#xD;
          -  Local resident, with transportation to the CHRC at the Hamilton Health Sciences&#xD;
             General Division.&#xD;
&#xD;
          -  Ability to understand written and verbal instructions and provide written informed&#xD;
             consent.&#xD;
&#xD;
          -  Stable medical therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-cardiac surgical procedure within two months&#xD;
&#xD;
          -  Positive exercise stress test (i.e. typical symptoms of chest discomfort and ECG&#xD;
             changes or positive nuclear scan)&#xD;
&#xD;
          -  Myocardial infarction within two months; coronary artery bypass graft surgery within&#xD;
             two months; percutaneous coronary intervention within one month&#xD;
&#xD;
          -  Baseline work capacity &lt; 25 W&#xD;
&#xD;
          -  NYHA class II-IV symptoms of heart failure&#xD;
&#xD;
          -  Documented significant valve stenosis&#xD;
&#xD;
          -  Symptomatic peripheral arterial disease that limits exercise capacity&#xD;
&#xD;
          -  Uncontrolled supraventricular or ventricular dysrhythmia&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Uncontrolled hypertension (blood pressure &gt;160/90 mmHg)&#xD;
&#xD;
          -  Documented chronic obstructive pulmonary disease (FEV1 &lt;60% and/or FVC &lt;60%)&#xD;
&#xD;
          -  Any musculoskeletal abnormality that would limit exercise participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen J MacDonald, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiac Health and Rehabilitation Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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. Erratum In: Med Sci Sports Exerc. 2017 Mar;49(3):626.</citation>
    <PMID>28009784</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25689059</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 9, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac rehabilitation</keyword>
  <keyword>interval exercise</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235674
org study id: SCORE
nct id: NCT03235674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: brachial endothelial function as measured by flow-mediated dilation (FMD)
time frame: Change from baseline FMD at 12 weeks
description: 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.
measure: cardiorespiratory fitness
time frame: Change from baseline stress test at 12 weeks
description: Maximal aerobic capacity will be determined using a medically monitored exercise stress test.
measure: skeletal muscle capillary content
time frame: change from baseline capillary content at 12 weeks
description: 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).
measure: cardiac diastolic function
time frame: change from baseline left ventricular values at 12 weeks
description: 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.
arm group label: High-intensity stair climbing exercise
arm group type: Experimental
description: 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.
arm group label: standard cardiac rehabilitation exercise
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: High-intensity stair climbing exercise
description: High intensity stair climbing exercise at a vigorous pace as measured by rating of perceived exertion.
arm group label: High-intensity stair climbing exercise
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maureen J MacDonald, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
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. Erratum In: Med Sci Sports Exerc. 2017 Mar;49(3):626.
PMID: 28009784
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.
PMID: 25689059
responsible party type: Sponsor
sharing ipd: No