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

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

Sponsors

Lead sponsor: Ottawa Heart Institute Research Corporation

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

Source 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.

Overall Status Active, not recruiting
Start Date June 2016
Completion Date December 2020
Primary Completion Date May 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Exercise Capacity Baseline to 12 weeks and Baseline to 26 weeks
Secondary Outcome
Measure Time Frame
Functional Fitness Baseline to 12 weeks and Baseline to 26 weeks
Aortic stiffness Baseline to 12 weeks and Baseline to 26 weeks
Body Composition Baseline to 12 weeks and Baseline to 26 weeks
Body Composition Baseline to 12 weeks and Baseline to 26 weeks
Body Composition Baseline to 12 weeks and Baseline to 26 weeks
Depression Baseline to 12 weeks and Baseline to 26 weeks
Quality of Life - SF36 Baseline to 12 weeks and Baseline to 26 weeks
Quality of Life - HeartQoL Baseline to 12 weeks and Baseline to 26 weeks
Exercise Adherence Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms Baseline to 12 weeks and Baseline to 26 weeks
Depression mechanisms Baseline to 12 weeks and Baseline to 26 weeks
Lipid and glucose profile Baseline to 12 weeks and Baseline to 26 weeks
Lipid and glucose profile Baseline to 12 weeks and Baseline to 26 weeks
Lipid and glucose profile Baseline to 12 weeks and Baseline to 26 weeks
Lipid and glucose profile Baseline to 12 weeks and Baseline to 26 weeks
Enrollment 135
Condition
Intervention

Intervention type: Behavioral

Intervention name: High Intensity Interval Training

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

Arm group label: High Intensity Interval Training

Other name: HIIT

Intervention type: Behavioral

Intervention name: Moderate Intensity Continuous Exercise Training

Description: 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.

Arm group label: Moderate Intensity Continuous Exercise

Other name: MICE

Intervention type: Behavioral

Intervention name: Nordic Walking

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

Arm group label: Nordic Walking

Other name: NW

Eligibility

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;

Gender: All

Minimum age: 40 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jennifer L Reed, PhD Principal Investigator Ottawa Heart Institute Research Corporation
Location
facility University of Ottawa Heart Insititue
Location Countries

Canada

Verification Date

December 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Moderate Intensity Continuous Exercise

Arm group type: Experimental

Description: Moderate Intensity Continuous Exercise Training

Arm group label: Nordic Walking

Arm group type: Experimental

Description: Nordic Walking

Arm group label: High Intensity Interval Training

Arm group type: Experimental

Description: High Intensity Interval Training

Acronym CRX-Modalities
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov