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Completed

NCT Number: NCT02765568

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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Insititue

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;

Treatment and study plan

High Intensity Interval Training

Behavioral

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

Other names: HIIT

Moderate Intensity Continuous Exercise Training

Behavioral

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.

Other names: MICE

Nordic walking

Behavioral

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

Other names: NW

Primary outcomes

  1. Exercise Capacity

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

Secondary outcomes

  1. Functional Fitness

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  2. Aortic stiffness

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  3. Body Composition

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  4. Body Composition

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  5. Body Composition

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  6. Depression

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  7. Quality of Life - SF36

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  8. Quality of Life - HeartQoL

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  9. Exercise Adherence

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  10. Depression mechanisms

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  11. Depression mechanisms

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  12. Depression mechanisms

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  13. Lipid and glucose profile

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  14. Lipid and glucose profile

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  15. Lipid and glucose profile

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

  16. Lipid and glucose profile

    Time frame: Baseline to 12 weeks and Baseline to 26 weeks

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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • Ontario Ministry of Health and Long Term Care

Registry information

Acronym: CRX-Modalities

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 6, 2016
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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