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Coronary Artery Disease (CAD)CRX-ModalitiesNCT02765568

Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes

A study testing High Intensity Interval Training, Moderate Intensity Continuous Exercise Training and Nordic Walking in people with Coronary Artery Disease (CAD), run by Ottawa Heart Institute Research Corporation 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

Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Coronary Artery Disease (CAD)
What is being tested?
High Intensity Interval Training, Moderate Intensity Continuous Exercise Training and Nordic Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteCanada
Study dates
Jun 2016to 16 Oct 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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with CAD who recently underwent PCI (within 2-10 weeks) PCI or coronary artery bypass grafting (within the last 18 weeks);
  • Patient is referred to University of Ottawa Heart Institute cardiac rehabilitation program;
  • Patient is able to walk independently
  • Patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks;
  • At least 40 years of age;
  • Patient is willing and able to provide informed consent

Who cannot join

  • Currently participating in routine exercise training (>2x/week) and/or using Nordic Walking poles;
  • Active infection or inflammatory condition;
  • Over 75 years of age;
  • Persistent or permanent atrial fibrillation;
  • Pregnant, lactating or planning to become pregnant during the trial period;
  • Unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy;
  • Unable to read and understand English or French;
  • Unwilling or unable to return for follow-up visit at weeks 12 and 26;

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Insititue

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Coronary revascularization improves survival for patients with coronary artery disease. However,many patients are left with poor physical and mental health. Traditional cardiac rehabilitation involves moderate intensity continuous exercise (MICE). Alternatives to traditional cardiac rehabilitation programming may however provide superior understudied benefits to patients with poor physical and mental health. Nordic walking (NW) and high-intensity interval training (HIIT) are two examples of alternative programs for cardiac rehabilitation, which may provide superior physical and mental health benefits when compared to traditional MICE. The main purpose of this project is, therefore, to determine the short and long term physical and mental health benefits of alternative cardiac rehabilitation modalities, including NW and HIIT on exercise capacity, quality of life and depression after a 12-week program.

Being tested
High Intensity Interval Training, Moderate Intensity Continuous Exercise Training, Nordic Walking
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • High Intensity Interval TrainingBehavioural

    Also called HIIT

    Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks

  • Moderate Intensity Continuous Exercise TrainingBehavioural

    Also called MICE

    Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.

  • Nordic WalkingBehavioural

    Also called NW

    Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks

Study groups in NCT02765568
Study groupRoleWhat they receive
Moderate Intensity Continuous ExerciseExperimentalModerate Intensity Continuous Exercise Training
Receives: Behavioral: Moderate Intensity Continuous Exercise Training
Nordic WalkingExperimentalNordic Walking
Receives: Behavioral: Nordic Walking
High Intensity Interval TrainingExperimentalHigh Intensity Interval Training
Receives: Behavioral: High Intensity Interval Training

What is being measured

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

  1. Exercise Capacity

    Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

Secondary outcomes (16)

  1. Functional Fitness

    Changes in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  2. Aortic stiffness

    Changes in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  3. Body Composition

    Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  4. Body Composition

    Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  5. Body Composition

    Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by body mass index.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  6. Depression

    Changes in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  7. Quality of Life - SF36

    Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the Short Form-36.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  8. Quality of Life - HeartQoL

    Changes in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the HeartQoL questionnaire

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  9. Exercise Adherence

    Changes in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  10. Depression mechanisms

    Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  11. Depression mechanisms

    Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma irisin.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  12. Depression mechanisms

    Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma kynurenine.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  13. Lipid and glucose profile

    Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma total cholesterol.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  14. Lipid and glucose profile

    Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Low Density Lipoprotein

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  15. Lipid and glucose profile

    Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma High Density Lipoprotein.

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

  16. Lipid and glucose profile

    Changes in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma Hemoglobin A1c

    Measured: Baseline to 12 weeks and Baseline to 26 weeks

Timeline

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

  1. First posted6 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion16 Oct 2019
  4. Study completion16 Oct 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765568
Sponsor's protocol ID
20160127-01H
Acronym
CRX-Modalities
Status last verified
Oct 2020
First submitted
29 Apr 2016
Last updated
30 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Marcal IR, Cotie LM, Ribeiro I, Reed JL. The Effects of Different Exercise Modalities and Intensities on Arterial Stiffness in Patients With Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 Sep 1;43(5):384-385. doi: 10.1097/HCR.0000000000000799. Epub 2023 May 15. No abstract available.

    PubMed 37184470

  • Garneau L, Terada T, Mistura M, Mulvihill EE, Reed JL, Aguer C. Exercise training reduces circulating cytokines in male patients with coronary artery disease and type 2 diabetes: A pilot study. Physiol Rep. 2023 Mar;11(5):e15634. doi: 10.14814/phy2.15634.

    PubMed 36905198

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training, Moderate Intensity Continuous Exercise Training and Nordic Walking in people with Coronary Artery Disease (CAD), run by Ottawa Heart Institute Research Corporation 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 6 inclusion and 8 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 30 Oct 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?

Exercise Capacity (time frame: Baseline to 12 weeks and Baseline to 26 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 NCT02765568, which also lists 2 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 30 Oct 2020.

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