- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806841
Effect of a Motivational Intervention on Exercise Adherence After Cardiac Rehabilitation (IMREADAP)
February 4, 2025 updated by: Louis Bherer
The Canadian Physical Activity Guidelines recommend that adults should exercise for at least 150 minutes per week.
Incorporating 150 minutes of moderate-to-vigorous intensity physical activity (MVPA) a week has been associated with the prevention of at least 25 chronic diseases, including cardiovascular disease.
However, most people do not successfully maintain this active behavior.
The primary objective of this investigation is to understand what predicts successful exercise adherence and why people dropout from the gym.
The long-term impact of this study has implications for future policy level interventions aimed at exercise adherence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The participants will receive a link to the baseline survey at www.surveymonkey.com.
After completing the survey, the participants will be randomized into an intervention or a control group.
The intervention group will be invited to attend a group meeting at weeks 1, 6 and 12 (3-month mark) which will take place at the EPIC center.
These meetings will help participants create effective goals and methods on maintaining their motivation to exercise regularly.
The participants will then receive a monthly phone call follow-up at months 4-6.
The purpose of these meeting/follow-ups is to serve as a review of the worksheet, address any questions and help make any modification plans if necessary.
Participants in the control group will be simply encouraged to exercise at the EPIC center and complete the online surveys.
Participants in the control group will receive the skills/tactics at the end of the study.
As members of the EPIC center, all participants will have access to four weekly supervised sesssions for three months.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T1N6
- Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 50 years and older, included in the prevention clinique at Epic Center after an acute coronary syndrome (≤ 12 months) with or without revascularization, doing less than 150 minutes of physical activity per week. The approval of a cardiologist is needed to take part in this program. A normal score on the MoCA (≥ 26) is needed.
Exclusion Criteria:
- Valve surgery without any coronary event, non-cardiopulmonary exercise limitation, stress induce malignant arrhythmia and decompensate heart failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants will have access to 4 weekly supervised training sessions for 3 months.
The intervention group will also take part in 3 group meetings (behavioral intervention) and will receive follow-up phone calls from month 4 to 6.
|
Three group meeting of 60 minutes to help create effective goals and methods on maintaining motivation to exercise regularly.
These meetings will help participants create effective goals and methods on maintaining their motivation to exercise regularly.
They will then receive a monthly phone call follow-up at months 4-6.
|
|
Experimental: Control group
Participants will have access to 4 weekly supervised training sessions for 3 months without any behavioral intervention.
|
Participants in the control group will be simply encouraged to exercise at the EPIC center and complete the online surveys.
Participants in the control group will receive the skills/tactics at the end of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level
Time Frame: Baseline and 6 months
|
Godin Leisure Time Exercise Questionnaire (GLTEQ).
Frequency and duration are open-ended questions with 0 set as minimum and with no maximum.
Higher value indicates greater participation in physical activity.
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autoregulation / Self-control
Time Frame: Baseline and 6 months
|
Self-reported activity journal
|
Baseline and 6 months
|
|
Behavioral automaticity
Time Frame: Baseline and 6 months
|
Self-Report Behavioral Automaticity Index (SRBAI) The complete name of the scale is the "Self-Report Behavioral Automaticity Index".
The scores on this scale range from 1 to 5, with 1 indicating less use of automatic process and 5 indicating a strong use of automatic processes when exercising.
Higher scores are preferrable/represent better outcome as they indicate that exercise behavior is performed easily.
|
Baseline and 6 months
|
|
Behavioral regulation
Time Frame: Baseline and 6 months
|
Intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2).
Behavioral Regulation was assessed by a scale proposed by Sniehotta, Scholz, & Schwarzer (2006), which does not have a specific title.
The scores on this scale range from 1 to 5, with 1 indicating less use of planning and 5 indicating a strong use of planning for their exercise sessions.
Higher scores are preferrable/represent better outcome as they indicate that participants make plans to schedule their exercise sessions.
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Warburton DE, Katzmarzyk PT, Rhodes RE, Shephard RJ. Evidence-informed physical activity guidelines for Canadian adults. Can J Public Health. 2007;98 Suppl 2:S16-68.
- Godin G, Jobin J, Bouillon J. Assessment of leisure time exercise behavior by self-report: a concurrent validity study. Can J Public Health. 1986 Sep-Oct;77(5):359-62. No abstract available.
- Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982 Jul;92(1):111-35. No abstract available.
- Gardner B, Abraham C, Lally P, de Bruijn GJ. Towards parsimony in habit measurement: testing the convergent and predictive validity of an automaticity subscale of the Self-Report Habit Index. Int J Behav Nutr Phys Act. 2012 Aug 30;9:102. doi: 10.1186/1479-5868-9-102.
- Rhodes RE, de Bruijn GJ. What predicts intention-behavior discordance? A review of the action control framework. Exerc Sport Sci Rev. 2013 Oct;41(4):201-7. doi: 10.1097/JES.0b013e3182a4e6ed.
- Kaushal N, Rhodes RE. Exercise habit formation in new gym members: a longitudinal study. J Behav Med. 2015 Aug;38(4):652-63. doi: 10.1007/s10865-015-9640-7. Epub 2015 Apr 8.
- Kaushal N, Rhodes RE, Spence JC, Meldrum JT. Increasing Physical Activity Through Principles of Habit Formation in New Gym Members: a Randomized Controlled Trial. Ann Behav Med. 2017 Aug;51(4):578-586. doi: 10.1007/s12160-017-9881-5.
- Blanchard CM. Heart disease and physical activity: looking beyond patient characteristics. Exerc Sport Sci Rev. 2012 Jan;40(1):30-6. doi: 10.1097/JES.0b013e318234c206.
- Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet. 2005 Apr 9-15;365(9467):1348-53. doi: 10.1016/S0140-6736(05)61034-3.
- Godin G, Shephard RJ, Colantonio A. The cognitive profile of those who intend to exercise but do not. Public Health Rep. 1986 Sep-Oct;101(5):521-6.
- Shek DT, Ma CM. Longitudinal data analyses using linear mixed models in SPSS: concepts, procedures and illustrations. ScientificWorldJournal. 2011 Jan 5;11:42-76. doi: 10.1100/tsw.2011.2.
- West BT. Analyzing longitudinal data with the linear mixed models procedure in SPSS. Eval Health Prof. 2009 Sep;32(3):207-28. doi: 10.1177/0163278709338554. Epub 2009 Aug 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2018
Primary Completion (Actual)
August 22, 2019
Study Completion (Actual)
November 22, 2019
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (Actual)
March 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2017-2235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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