AgingIMREADAPNCT04806841
Effect of a Motivational Intervention on Exercise Adherence After Cardiac Rehabilitation
A study testing Motivational intervention in people with Aging, run by Louis Bherer at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Motivational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 29 Nov 2018to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Valve surgery without any coronary event, non-cardiopulmonary exercise limitation, stress induce malignant arrhythmia and decompensate heart failure
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Motivational intervention, Control intervention
- Keywords
- Aging, Motivation, Cardiac rehabilitation, Exercise adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interventionBehavioural
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.
Control interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Motivational intervention |
| Control group | Experimental | Participants will have access to 4 weekly supervised training sessions for 3 months without any behavioral intervention. Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
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.
Measured: Baseline and 6 months
Secondary outcomes (3)
Behavioral automaticity
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.
Measured: Baseline and 6 months
Autoregulation / Self-control
Self-reported activity journal
Measured: Baseline and 6 months
Behavioral regulation
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start29 Nov 2018
- Primary completion22 Aug 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Bherer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louis Bherer, Montreal Heart Institute
- Investigators
- Louis Bherer, PhD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806841
- Sponsor's protocol ID
- 2017-2235
- Acronym
- IMREADAP
- Status last verified
- Jun 2021
- First submitted
- 17 Mar 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23873134Kaushal 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.
PubMed 25851609Kaushal 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.
PubMed 28188586Warburton 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.
PubMed 18213940Blanchard 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.
PubMed 21918456Schulz 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.
PubMed 15823387Godin 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.
PubMed 3791117Godin 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.
PubMed 3094084Gardner 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.
PubMed 22935297Carver 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.
PubMed 7134324Shek 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.
PubMed 21218263West 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.
PubMed 19679634
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Motivational Intervention on Exercise Adherence After Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04806841
- Acronym / sponsor ID
- IMREADAP / 2017-2235
- Conditions
- Aging
- Keywords
- Aging, Motivation, Cardiac rehabilitation, Exercise adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Louis BhererUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 22 Aug 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational interventionParticipants 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. |
| Control group | Experimental | Other: Control interventionParticipants will have access to 4 weekly supervised training sessions for 3 months without any behavioral intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Valve surgery without any coronary event, non-cardiopulmonary exercise limitation, stress induce malignant arrhythmia and decompensate heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interventionThree 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. | Behavioural | Intervention group |
| Control interventionParticipants 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. | Other | Control group |
Primary outcome
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.
3 secondary outcomes
Behavioral automaticity
Time frame: Baseline and 6 months
Autoregulation / Self-control
Time frame: Baseline and 6 months
Behavioral regulation
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 23873134Rhodes 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.
- Background: PubMed 25851609Kaushal 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.
- Background: PubMed 28188586Kaushal 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.
- Background: PubMed 18213940Warburton 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.
- Background: PubMed 21918456Blanchard 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.
- Background: PubMed 15823387Schulz 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.
- Background: PubMed 3791117Godin 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.
- Background: PubMed 3094084Godin 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.
- Background: PubMed 22935297Gardner 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.
- Background: PubMed 7134324Carver 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.
- Background: PubMed 21218263Shek 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.
- Background: PubMed 19679634West 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Bherer, PhD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational intervention in people with Aging, run by Louis Bherer at 1 site 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 1 inclusion and 1 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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity level (time frame: Baseline and 6 months). 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 NCT04806841, which also lists 12 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 7 Feb 2025.