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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease (CAD)

Intervention / Treatment
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* Behavioral: High Intensity Interval Training
* Behavioral: Moderate Intensity Continuous Exercise Training
* Behavioral: Nordic Walking


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Intensity Continuous Exercise<br>Moderate Intensity Continuous Exercise Training | Behavioral: Moderate Intensity Continuous Exercise Training<br>* 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.<br>* Other names: MICE;|
| Experimental: Nordic Walking<br>Nordic Walking | Behavioral: Nordic Walking<br>* Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks<br>* Other names: NW;|
| Experimental: High Intensity Interval Training<br>High Intensity Interval Training | Behavioral: High Intensity Interval Training<br>* Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks<br>* Other names: HIIT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)