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Coronary Artery DiseaseECOPCRNCT01658683

The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation

A study testing Exercise Facilitator Intervention in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Exercise Facilitator Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
449 participants
Where
2 sitesCanada
Study dates
Oct 2012to Jul 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • York University and University Health Network

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

Official title: 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, 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.

Being tested
Exercise Facilitator Intervention
Keywords
Coronary Artery Disease, Cardiac Rehabilitation, Exercise Maintenance, Facilitator, Managed Home Exercise, Community Based Exercise
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise Facilitator InterventionBehavioural

    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.

Study groups in NCT01658683
Study groupRoleWhat they receive
Exercise Facilitator InterventionExperimentalThe intervention employs small group counseling teleconferences (5),personal telephone contacts (3) and community Heart Wise Exercise program demonstrations.
Receives: Behavioral: Exercise Facilitator Intervention
Usual CareNo interventionUsual 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity

    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. The results report the average minutes of exercise recorded across the full 9 days wearing the accelerometer.

    Measured: Baseline to 52 weeks

  2. 9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity (>/= 10min Sessions)

    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.

    Outcome measure 2 reports the average number of minutes recorded over the full 9 days of wearing the accelerometer, but only when the exercise events last for at least 10 minutes. This differs from Primary Outcome 1 because Primary Outcome 1 is an average of all bouts of exercise regardless of sustained time.

    Measured: Baseline to 52 weeks

Secondary outcomes (5)
  1. Symptom Limited Graded Exercise Test With Electrocardiographic Monitoring Using a Ramp Protocol on a Treadmill

    A random sub-sample of participants 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

    Measured: Baseline and 52 weeks

  2. Quality of Life Measured by the the EuroQoL 5D Visual Analogue Scale

    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. The Visual analogue scale ranges from 0-100 with 0 rated as the worst health, and 100 being the best health.

    Measured: Baseline to 52 weeks

  3. Cardiovascular Risk Factors Measured by Waist Circumference

    Waist circumference is measured using a non-stretchable standard tape measure.

    Measured: 52 weeks

  4. Cardiovascular Risk Factors Measured by Systolic Blood Pressure.

    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. The results represent the average measurements of the six measurements taken.

    Measured: 52 weeks

  5. Cardiovascular Risk Factors Measured by Body Mass Index

    Height and weight is measured for the determination of body mass index (BMI).

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMar 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01658683
Sponsor's protocol ID
201200579-01
Acronym
ECOPCR
Status last verified
Feb 2022
First submitted
1 Aug 2012
Last updated
14 Aug 2026
Data monitoring committee
No

Publications

  • Grace SL, Chessex C, Arthur H, Chan S, Cyr C, Dafoe W, Juneau M, Oh P, Suskin N. Systematizing Inpatient Referral to Cardiac Rehabilitation 2010: Canadian association of cardiac rehabilitation and Canadian cardiovascular society joint position paper. J Cardiopulm Rehabil Prev. 2011 May-Jun;31(3):E1-8. doi: 10.1097/HCR.0b013e318219721f.

    PubMed 21460733
  • Blanchard CM, Reid RD, Morrin LI, McDonnell L, McGannon K, Rhodes RE, Spence JC, Edwards N. Demographic and clinical determinants of moderate to vigorous physical activity during home-based cardiac rehabilitation: the home-based determinants of exercise (HOME) study. J Cardiopulm Rehabil Prev. 2010 Jul-Aug;30(4):240-5. doi: 10.1097/HCR.0b013e3181d0c4ae.

    PubMed 20216322
  • Reid RD, Morrin LI, Pipe AL, Dafoe WA, Higginson LA, Wielgosz AT, LeHaye SA, McDonald PW, Plotnikoff RC, Courneya KS, Oldridge NB, Beaton LJ, Papadakis S, Slovinec D'Angelo ME, Tulloch HE, Blanchard CM. Determinants of physical activity after hospitalization for coronary artery disease: the Tracking Exercise After Cardiac Hospitalization (TEACH) Study. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):529-37. doi: 10.1097/01.hjr.0000201513.13343.97.

    PubMed 16874141
  • Blanchard CM, Courneya KS, Rodgers WM, Fraser SN, Murray TC, Daub B, Black B. Is the theory of planned behavior a useful framework for understanding exercise adherence during phase II cardiac rehabilitation? J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):29-39. doi: 10.1097/00008483-200301000-00007.

    PubMed 12576910
  • Reid RD, Dafoe WA, Morrin L, Mayhew A, Papadakis S, Beaton L, Oldridge NB, Coyle D, Wells GA. Impact of program duration and contact frequency on efficacy and cost of cardiac rehabilitation: results of a randomized trial. Am Heart J. 2005 May;149(5):862-8. doi: 10.1016/j.ahj.2004.09.029.

    PubMed 15894969
  • Bock BC, Carmona-Barros RE, Esler JL, Tilkemeier PL. Program participation and physical activity maintenance after cardiac rehabilitation. Behav Modif. 2003 Jan;27(1):37-53. doi: 10.1177/0145445502238692.

    PubMed 12587259
  • Izawa KP, Yamada S, Oka K, Watanabe S, Omiya K, Iijima S, Hirano Y, Kobayashi T, Kasahara Y, Samejima H, Osada N. Long-term exercise maintenance, physical activity, and health-related quality of life after cardiac rehabilitation. Am J Phys Med Rehabil. 2004 Dec;83(12):884-92. doi: 10.1097/01.phm.0000143404.59050.11.

    PubMed 15624566
  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PubMed 4053261
  • Sallis JF, Kerr J, Carlson JA, Norman GJ, Saelens BE, Durant N, Ainsworth BE. Evaluating a brief self-report measure of neighborhood environments for physical activity research and surveillance: Physical Activity Neighborhood Environment Scale (PANES). J Phys Act Health. 2010 Jul;7(4):533-40. doi: 10.1123/jpah.7.4.533.

    PubMed 20683096
  • Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003.

    PubMed 15725977
  • Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.

    PubMed 21735386
  • Hodges JM. Reflections: Occupational therapy. Am J Occup Ther. 1976 Aug;30(7):409-10. No abstract available.

    PubMed 782256
  • Izawa KP, Watanabe S, Omiya K, Hirano Y, Oka K, Osada N, Iijima S. Effect of the self-monitoring approach on exercise maintenance during cardiac rehabilitation: a randomized, controlled trial. Am J Phys Med Rehabil. 2005 May;84(5):313-21. doi: 10.1097/01.phm.0000156901.95289.09.

    PubMed 15829777
  • Johnson NA, Lim LL, Bowe SJ. Multicenter randomized controlled trial of a home walking intervention after outpatient cardiac rehabilitation on health-related quality of life in women. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):633-7. doi: 10.1097/HJR.0b013e32832e8eba.

    PubMed 19543092

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Facilitator Intervention in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity (time frame: Baseline to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01658683, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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