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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02765568
Acronym
CRX-Modalities
Enrollment
135
Registered
2016-05-06
Start date
2016-06-30
Completion date
2019-10-16
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Keywords

Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)

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.

Interventions

BEHAVIORALHigh Intensity Interval Training

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

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.

BEHAVIORALNordic Walking

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

Sponsors

Ontario Ministry of Health and Long Term Care
CollaboratorOTHER_GOV
Heart and Stroke Foundation of Canada
CollaboratorOTHER
Ottawa Heart Institute Research Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Exercise CapacityBaseline to 12 weeks and Baseline to 26 weeksChanges in exercise capacity from baseline to 12 weeks and baseline to 26 weeks are measured by the six-minute walk test

Secondary

MeasureTime frameDescription
Aortic stiffnessBaseline to 12 weeks and Baseline to 26 weeksChanges in aortic stiffness from baseline to 12 weeks and baseline to 26 weeks are measured by pulse wave velocity
Body CompositionBaseline to 12 weeks and Baseline to 26 weeksChanges in body composition from baseline to 12 weeks and baseline to 26 weeks are measured by the waist circumference.
DepressionBaseline to 12 weeks and Baseline to 26 weeksChanges in depression from baseline to 12 weeks and baseline to 26 weeks are measured by the Beck Depression Inventory-II questionnaire
Quality of Life - SF36Baseline to 12 weeks and Baseline to 26 weeksChanges in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the Short Form-36.
Functional FitnessBaseline to 12 weeks and Baseline to 26 weeksChanges in functional fitness from baseline to 12 weeks and baseline to 26 weeks are measured by the Senior Fitness Test
Exercise AdherenceBaseline to 12 weeks and Baseline to 26 weeksChanges in exercise adherence from baseline to 12 weeks and baseline to 26 weeks are measured by the Actigraph accelerometer
Depression mechanismsBaseline to 12 weeks and Baseline to 26 weeksChanges in depression mechanisms from baseline to 12 weeks and baseline to 26 weeks are measured by plasma brain derived neurotrophic factor.
Lipid and glucose profileBaseline to 12 weeks and Baseline to 26 weeksChanges in lipid and glucose profile from baseline to 12 weeks and baseline to 26 weeks are measured by plasma total cholesterol.
Quality of Life - HeartQoLBaseline to 12 weeks and Baseline to 26 weeksChanges in quality of life from baseline to 12 weeks and baseline to 26 weeks are measured by the HeartQoL questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026