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

Coronary Artery Disease (CAD) Clinical Trial

— CRX-Modalities  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765568
• Other study ID #: 20160127-01H
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 16, 2019

Study information

• Verified date: October 2020
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Insititue	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Canada, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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