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Trial record 31 of 348 for:    high intensity | Canada

Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes (CRX-Modalities)

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ClinicalTrials.gov Identifier: NCT02765568
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : September 21, 2017
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Behavioral: High Intensity Interval Training Behavioral: Moderate Intensity Continuous Exercise Training Behavioral: Nordic Walking Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Study Start Date : June 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Moderate Intensity Continuous Exercise
Moderate Intensity Continuous Exercise Training
Behavioral: Moderate Intensity Continuous Exercise Training
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 Name: MICE

Experimental: Nordic Walking
Nordic Walking
Behavioral: Nordic Walking
Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks
Other Name: NW

Experimental: High Intensity Interval Training
High Intensity Interval Training
Behavioral: High Intensity Interval Training
Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks
Other Name: HIIT




Primary Outcome Measures :
  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 Outcome Measures :
  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 [ 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 [ 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



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765568


Contacts
Contact: Jennifer L Reed, PhD 6136967392 jreed@ottawaheart.ca
Contact: Lisa M Cotie, PhD 6136967000 ext 15944 lcotie@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Insititue Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Ontario Ministry of Health and Long Term Care
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02765568     History of Changes
Other Study ID Numbers: 20160127-01H
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Heart Institute Research Corporation:
Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases