NCT03235674

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

February 26, 2020

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

June 9, 2017

Last Update Submit

February 25, 2020

Conditions

Endothelial Dysfunction

Keywords

Cardiac rehabilitationinterval exercise

Outcome Measures

Primary Outcomes (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.

    Change from baseline FMD at 12 weeks

Secondary Outcomes (3)

  • cardiorespiratory fitness

    Change from baseline stress test at 12 weeks

  • skeletal muscle capillary content

    change from baseline capillary content at 12 weeks

  • cardiac diastolic function

    change from baseline left ventricular values at 12 weeks

Study Arms (2)

High-intensity stair climbing exercise

EXPERIMENTAL

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

standard cardiac rehabilitation exercise

NO INTERVENTION

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.

Interventions

High-intensity stair climbing exerciseOTHER

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

High-intensity stair climbing exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Health and Rehabilitation Centre

Hamilton, Ontario, Canada

Location

Related Publications (5)

  • 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.

    PMID: 28009784BACKGROUND

  • 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: 25689059BACKGROUND

  • 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.

    PMID: 35591811DERIVED

  • 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.

    PMID: 33665614DERIVED

  • 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.

    PMID: 33394901DERIVED

Study Officials

  • Maureen J MacDonald, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

August 1, 2017

Study Start

January 30, 2018

Primary Completion

August 8, 2019

Study Completion

September 30, 2019

Last Updated

February 26, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)