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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Motivational intervention
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.
Other: Control 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louis Bherer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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