NCT04806841

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

February 7, 2025

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

March 17, 2021

Last Update Submit

February 4, 2025

Conditions

Keywords

AgingMotivationCardiac rehabilitationExercise adherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 6 months

Secondary Outcomes (3)

  • Behavioral automaticity

    Baseline and 6 months

  • Autoregulation / Self-control

    Baseline and 6 months

  • Behavioral regulation

    Baseline and 6 months

Study Arms (2)

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.

Behavioral: Motivational intervention

Control group

EXPERIMENTAL

Participants will have access to 4 weekly supervised training sessions for 3 months without any behavioral intervention.

Other: Control intervention

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Valve surgery without any coronary event, non-cardiopulmonary exercise limitation, stress induce malignant arrhythmia and decompensate heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (12)

  • 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.

    PMID: 23873134BACKGROUND
  • 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.

    PMID: 25851609BACKGROUND
  • 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.

    PMID: 28188586BACKGROUND
  • 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.

    PMID: 18213940BACKGROUND
  • 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.

    PMID: 21918456BACKGROUND
  • 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.

    PMID: 15823387BACKGROUND
  • 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.

    PMID: 3791117BACKGROUND
  • 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.

    PMID: 3094084BACKGROUND
  • 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.

    PMID: 22935297BACKGROUND
  • 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.

    PMID: 7134324BACKGROUND
  • 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.

    PMID: 21218263BACKGROUND
  • 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.

    PMID: 19679634BACKGROUND

Study Officials

  • Louis Bherer, PhD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate scientific director, Direction of prevention, Montreal Heart Institute

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 19, 2021

Study Start

November 29, 2018

Primary Completion

August 22, 2019

Study Completion

November 22, 2019

Last Updated

February 7, 2025

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations