The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation (ECOPCR)
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|ClinicalTrials.gov Identifier: NCT01658683|
Recruitment Status : Active, not recruiting
First Posted : August 7, 2012
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Behavioral: Exercise Facilitator Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||451 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: A Randomized Controlled Trial of Efficacy With Economics|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Exercise Facilitator Intervention
The intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.
Behavioral: Exercise Facilitator Intervention
The 50 week intervention includes 5 small group counseling teleconferences, 3 personal telephone calls and Heart Wise Exercise program demonstrations. During the teleconferences and personal telephone calls, the facilitator discusses the importance of exercise. Participants review their activity diaries, identify barriers to exercise maintenance experienced to date and brainstorm solutions as a group. In addition, the facilitator conducts community program demonstrations at Heart Wise Exercise program locations in Ottawa and Toronto for interested participants.
No Intervention: Usual Care
Usual care for cardiac rehab graduates provided by the University of Ottawa Heart Institute Minto Prevention & Rehabilitation Centre and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network.
- 9-day accelerometer-measured physical activity of moderate and vigorous intensity [ Time Frame: 78 weeks ]Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days.
- Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill [ Time Frame: 52 weeks ]A random sub-sample of participants (N = 124) will complete a symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill at baseline and at 52 weeks. Exercise tolerance will also be assessed using the Duke Activity Status Index (DASI), a self-administered questionnaire that measures a patient's functional capacity and is used as an estimate of an individual's peak oxygen uptake
- Quality of life measured by the the EuroQoL 5D [ Time Frame: 78 weeks ]The EQ-5D is the current gold standard measure of generic quality of life, has been used in numerous studies and has been validated in many languages. The EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
- Cardiovascular risk factors measured by body mass index and blood pressure. [ Time Frame: 78 weeks ]Height and weight is measured for the determination of body mass index (BMI). Waist circumference is measured using a non-stretchable standard tape measure. Systolic blood pressure is measured in a seated position after a five-minute rest period using an automated, non-invasive blood pressure monitor (BPTru) that automatically performs six measurements
- Enrollment in Heart Wise Exercise programs [ Time Frame: 78 weeks ]Enrollment in community-based and Heart Wise Exercise programs will be queried in the follow-up surveys.
- Mediators of Intervention Effect [ Time Frame: 78 weeks ]1.Physical activity history 2.Physical activity self-regulation 3. Action planning 4. Intentions to exercise 5. Beliefs about the benefits of and barriers to exercise 5. Task self-efficacy 6. Barrier self-efficacy 7. Social support from family and friends 8. Autonomy support derived from health care providers 9. Home exercise equipment 10. Neighbourhood environmental attributes of walkability and access to recreation facilities 11. Adherence to medications
- Cost-effectiveness and cost-utility [ Time Frame: 78 weeks ]Health effects are measured by overall survival time; event-free time from myocardial infarction, revascularization or death; and quality adjusted life years. Participants are linked to health administrative data to allow health care utilization to be tracked. Participants complete a monthly diary to record time for counseling and physical activities, out-of-pocket expenses, and items related to productivity, including lost work days, home care expenses due to reduced function or cardiac disability. Data is collected on the resources expended for each intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658683
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y4W7|
|York University and University Health Network|
|Toronto, Ontario, Canada, M5G2C4|
|Principal Investigator:||Robert Reid, MBA, PhD||Ottawa Heart Institute Research Corporation|
|Principal Investigator:||Sherry Grace, PhD||Peter Munk Cardiac Centre|
|Study Chair:||Andrew Pipe, MD||Ottawa Heart Institute Research Corporation|
|Study Chair:||Caroline Chessex, MD, MSc||Peter Munk Cardiac Centre|
|Study Chair:||Chris Blanchard, PhD||Dalhousie University|
|Study Chair:||Murray Krahn, MD, MSc||University of Toronto, Toronto Health Economics and Technology Assessment Collaborative|
|Study Chair:||Doug Manuel, MD||Institute for Clinical Evaluative Sciences|
|Study Chair:||Kori Kingsbury, MSN, MPA||Cardiac Care Network of Ontario|
|Study Chair:||Jennifer Harris, BSc, PT||Ottawa Heart Institute Research Corporation|
|Study Chair:||Kerri-Anne Mullen, MSc||Institute for Clinical Evaluative Sciences|
|Study Chair:||Amy Mark, PhD||Ottawa Heart Institute Research Corporation|