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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Behavioral: Moderate Intensity Continuous Exercise Training; Behavioral: Nordic Walking; Behavioral: High Intensity Interval Training

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Insititue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: MICE
EXPERIMENTAL: 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 Names: NW
EXPERIMENTAL: 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 Names: HIIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	Changes in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test	Baseline to 12 weeks and Baseline to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Fitness	Changes in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test	Baseline to 12 weeks and Baseline to 26 weeks
Aortic stiffness	Changes in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity	Baseline to 12 weeks and Baseline to 26 weeks
Body Composition	Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.	Baseline to 12 weeks and Baseline to 26 weeks
Body Composition	Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by bioelectrical impedance.	Baseline to 12 weeks and Baseline to 26 weeks
Body Composition	Changes in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by body mass index.	Baseline to 12 weeks and Baseline to 26 weeks
Depression	Changes in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire	Baseline to 12 weeks and Baseline to 26 weeks
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.	Baseline to 12 weeks and Baseline to 26 weeks
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	Baseline to 12 weeks and Baseline to 26 weeks
Exercise Adherence	Changes in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer	Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms	Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.	Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms	Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma irisin.	Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms	Changes in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma kynurenine.	Baseline to 12 weeks and Baseline to 26 weeks
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.	Baseline to 12 weeks and Baseline to 26 weeks
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	Baseline to 12 weeks and Baseline to 26 weeks
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.	Baseline to 12 weeks and Baseline to 26 weeks
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	Baseline to 12 weeks and Baseline to 26 weeks

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Ontario Ministry of Health and Long Term Care; Heart and Stroke Foundation of Canada

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): October 16, 2019
• Study Completion (ACTUAL): October 16, 2019

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (ESTIMATE): May 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 20160127-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO