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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806841
Other study ID # 2017-2235
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2018
Est. completion date November 22, 2019

Study information

Verified date March 2021
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date November 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Canada Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Louis Bherer

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet. 2005 Apr 9-15;365(9467):1348-53. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity level Godin Leisure Time Exercise Questionnaire (GLTEQ) Baseline and 6 months
Secondary Behavioral automaticity Self-Report Behavioral Automaticity Index (SRBAI) Baseline and 6 months
Secondary Autoregulation / Self-control Self-reported activity journal Baseline and 6 months
Secondary Behavioral regulation Intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Baseline and 6 months
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