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Endothelial DysfunctionSCORENCT03235674

Stair Climbing Outcomes in Cardiac Rehabilitation Exercise

A study testing High-intensity stair climbing exercise in people with Endothelial Dysfunction, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Endothelial Dysfunction
What is being tested?
High-intensity stair climbing exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
30 Jan 2018to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Cardiac Health and Rehabilitation Centre

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
High-intensity stair climbing exercise
Keywords
Cardiac rehabilitation, interval exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity stair climbing exerciseOther

    High intensity stair climbing exercise at a vigorous pace as measured by rating of perceived exertion.

Study groups in NCT03235674
Study groupRoleWhat they receive
High-intensity stair climbing exerciseExperimental3 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.
Receives: Other: High-intensity stair climbing exercise
standard cardiac rehabilitation exerciseNo interventionSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. brachial endothelial function as measured by flow-mediated dilation (FMD)

    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.

    Measured: Change from baseline FMD at 12 weeks

Secondary outcomes (3)

  1. cardiorespiratory fitness

    Maximal aerobic capacity will be determined using a medically monitored exercise stress test.

    Measured: Change from baseline stress test at 12 weeks

  2. skeletal muscle capillary content

    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).

    Measured: change from baseline capillary content at 12 weeks

  3. cardiac diastolic function

    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.

    Measured: change from baseline left ventricular values at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study start30 Jan 2018
  3. Primary completion8 Aug 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235674
Sponsor's protocol ID
SCORE
Acronym
SCORE
Status last verified
Aug 2019
First submitted
9 Jun 2017
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28009784

  • 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.

    PubMed 25689059

  • 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.

    PubMed 35591811

  • 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.

    PubMed 33665614

  • 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.

    PubMed 33394901

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity stair climbing exercise in people with Endothelial Dysfunction, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brachial endothelial function as measured by flow-mediated dilation (FMD) (time frame: Change from baseline FMD at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235674, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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