Clinical trial NCT02765568: Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Official title: Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease (CAD)
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Heart and Stroke Foundation of Canada
First posted: 2016-05-06
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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;

Primary outcomes:
measure: Exercise Capacity
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
Secondary outcomes:
measure: Functional Fitness
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Aortic stiffness
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Body Composition
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Body Composition
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Body Composition
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Depression
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Quality of Life - SF36
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Quality of Life - HeartQoL
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Exercise Adherence
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Depression mechanisms
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Depression mechanisms
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Depression mechanisms
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Lipid and glucose profile
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Lipid and glucose profile
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Lipid and glucose profile
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
measure: Lipid and glucose profile
timeFrame: Baseline to 12 weeks and Baseline to 26 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insititue
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer L Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: