Investigating the Effects of Cardiac Rehabilitation eXercise Modalities on Physical and Mental Health Outcomes
CRX-Modalities
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2019
CompletedOctober 30, 2020
October 1, 2020
3.4 years
April 29, 2016
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
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
- +11 more secondary outcomes
Study Arms (3)
Moderate Intensity Continuous Exercise
EXPERIMENTALModerate Intensity Continuous Exercise Training
Nordic Walking
EXPERIMENTALNordic Walking
High Intensity Interval Training
EXPERIMENTALHigh Intensity Interval Training
Interventions
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.
Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa Heart Insititue
Ottawa, Ontario, K1Y 4W7, Canada
Related Publications (2)
Marcal IR, Cotie LM, Ribeiro I, Reed JL. The Effects of Different Exercise Modalities and Intensities on Arterial Stiffness in Patients With Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 Sep 1;43(5):384-385. doi: 10.1097/HCR.0000000000000799. Epub 2023 May 15. No abstract available.
PMID: 37184470DERIVEDGarneau L, Terada T, Mistura M, Mulvihill EE, Reed JL, Aguer C. Exercise training reduces circulating cytokines in male patients with coronary artery disease and type 2 diabetes: A pilot study. Physiol Rep. 2023 Mar;11(5):e15634. doi: 10.14814/phy2.15634.
PMID: 36905198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Reed, PhD
Ottawa Heart Institute Research Corporation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 6, 2016
Study Start
June 1, 2016
Primary Completion
October 16, 2019
Study Completion
October 16, 2019
Last Updated
October 30, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share