Clinical trial NCT01658683: The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation
Official title: Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: A Randomized Controlled Trial of Efficacy With Economics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Cardiac Rehabilitation
Exercise Maintenance
Facilitator
Managed Home Exercise
Community Based Exercise
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2012-08-07
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop a new intervention to improve the transition of patients from structured, supervised exercise to self-managed home- or approved community-based exercise programs in an effort to increase maintenance of exercise behaviour post cardiac rehabilitation (CR). The goal of the study is that those receiving the intervention will engage in at least 30 minutes of physical activity at a moderate or vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in the usual care group. The new intervention will be delivered by trained exercise facilitators (physiotherapists or exercise specialists) and will make use of: small group counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program demonstrations that would facilitate linkages between patients and approved community programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network (Peter Munk Cardiac Centre \[PMCC\] and Toronto Rehabilitation Institute \[TRI\]) sites. The study has a target enrollment of 604 participants.


Eligibility criteria: Inclusion Criteria:

* Patient is currently participating in an on-site CR program of ≥ 8-week duration (to ensure that outcomes are not confounded by exposure to home-based or telephone-based case managed programs)
* Patient has graduated from CR (to ensure that the study is evaluating an intervention to help sustain and improve maintenance of exercise behaviour
* Patient has a documented diagnosis of CAD (to ensure homogeneity of the patient population)
* Patient is 18 years of age or older
* Patient is able and willing to provide informed consent
* Able to walk unaided at 2 mph

Exclusion Criteria:

* Patient has New York Heart Association class III or IV heart failure (because this might interfere with the ability to achieve recommended exercise levels and to ensure homogeneity of the patient population)
* Patient is pregnant, lactating or planning to become pregnant during the study period (because this might interfere with the ability to achieve recommended exercise levels)
* Patient is unable to read and understand English or French
* Planning to leave the province or region in the next 12 months
* Member of the participant's household is already participating in the study
* The participant is unable, in the opinion of the qualified investigator, to participate in unsupervised exercise.

Primary outcomes:
measure: 9-day accelerometer-measured physical activity of moderate and vigorous intensity
timeFrame: 78 weeks
Secondary outcomes:
measure: Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill
timeFrame: 52 weeks
measure: Quality of life measured by the the EuroQoL 5D
timeFrame: 78 weeks
measure: Cardiovascular risk factors measured by body mass index and blood pressure.
timeFrame: 78 weeks
measure: Enrollment in Heart Wise Exercise programs
timeFrame: 78 weeks
measure: Mediators of Intervention Effect
timeFrame: 78 weeks
measure: Cost-effectiveness and cost-utility
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: York University and University Health Network
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Reid, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peter Munk Cardiac Centre
name: Sherry Grace, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, MD
role: STUDY_CHAIR
affiliation: Peter Munk Cardiac Centre
name: Caroline Chessex, MD, MSc
role: STUDY_CHAIR
affiliation: Dalhousie University
name: Chris Blanchard, PhD
role: STUDY_CHAIR
affiliation: University of Toronto, Toronto Health Economics and Technology Assessment Collaborative
name: Murray Krahn, MD, MSc
role: STUDY_CHAIR
affiliation: Institute for Clinical Evaluative Sciences
name: Doug Manuel, MD
role: STUDY_CHAIR
affiliation: Cardiac Care Network of Ontario
name: Kori Kingsbury, MSN, MPA
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer Harris, BSc, PT
role: STUDY_CHAIR
affiliation: Institute for Clinical Evaluative Sciences
name: Kerri-Anne Mullen, MSc
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Amy Mark, PhD
role: STUDY_CHAIR
References:
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