The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation (ECOPCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Ottawa Heart Institute
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr Robert Reid, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01658683
First received: August 1, 2012
Last updated: August 7, 2014
Last verified: August 2014

August 1, 2012
August 7, 2014
October 2012
October 2015   (final data collection date for primary outcome measure)
9-day accelerometer-measured physical activity of moderate and vigorous intensity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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.
7-day accelerometer-measured physical activity of moderate and vigorous intensity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 7-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.
Complete list of historical versions of study NCT01658683 on ClinicalTrials.gov Archive Site
  • Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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: 52 weeks ] [ Designated as safety issue: No ]
    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: 52 weeks ] [ Designated as safety issue: No ]
    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: 52 weeks ] [ Designated as safety issue: No ]
    Enrollment in community-based and Heart Wise Exercise programs will be queried in the follow-up surveys.
  • Mediators of Intervention Effect [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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: 52 weeks ] [ Designated as safety issue: No ]
    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.
  • Symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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: 52 weeks ] [ Designated as safety issue: No ]
    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, blood pressure, and blood chemistry [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Height and weight is measured for the determination of body mass index (BMI). Waist circumference is measured using a non-stretchable standard tape measure. Levels of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides and HbA1C are determined from fasting blood samples using standardized laboratory procedures (only at baseline). Systolic blood pressure is measured in a seated position after a five-minute rest period using an automated, non-invasive blood pressure monitor (BPTru) 37 that automatically performs six measurements
  • Enrollment in Heart Wise Exercise programs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Enrollment in community-based and Heart Wise Exercise programs will be queried in the follow-up surveys. Self-reports of enrollment in Heart Wise Exercise programs will be validated with program registration data
  • Mediators of Intervention Effect [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

    The following mediators will be measured using valid, reliable, and pilot-tested scales:

    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: 52 weeks ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation
Ecologically Optimizing Exercise Maintenance in Men and Women Post-Cardiac Rehabilitation: A Randomized Controlled Trial of Efficacy With Economics

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 and 52 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 286 participants.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Coronary Artery Disease
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.
  • Experimental: Exercise Facilitator Intervention
    The intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.
    Intervention: Behavioral: Exercise Facilitator Intervention
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
286
October 2015
October 2015   (final data collection date for primary outcome measure)

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 attended ≥ 75% of scheduled CR sessions (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
Both
18 Years and older
No
Contact: Evyanne Wooding 613-798-5555 ext 17596 ewooding@ottawaheart.ca
Contact: Ashley Armstrong 613-798-5555 ext 19345 aarmstrong@ottawaheart.ca
Canada
 
NCT01658683
201200579-01
No
Dr Robert Reid, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Heart and Stroke Foundation of Ontario
Principal Investigator: Robert Reid, MBA, PhD University of Ottawa Heart Institute
Principal Investigator: Sherry Grace, PhD Peter Munk Cardiac Centre
Study Chair: Andrew Pipe, MD University of Ottawa Heart Institute
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 University of Ottawa Heart Institute
Study Chair: Kerri-Anne Mullen, MSc Institute for Clinical Evaluative Sciences
Study Chair: Amy Mark, PhD University of Ottawa Heart Institute
University of Ottawa Heart Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP