- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795802
Effect of Evaluative Conditioning on Intensity of Physical Activity of Patients Doing Cardiac Rehabilitation (Cardio'Activ)
Effect of Evaluative Conditioning on the Intensity of Physical Activity of Patients in a Cardiac Rehabilitation Program
The hypothesis is that, compared to those in the control group (i.e., diet-related evaluative conditioning), participants in the Physical Activity (PA) group (i.e. PA-friendly evaluative conditioning) will exhibit (1) a higher intensity (power setting) on an ergocycle during a free Physical Activity session in their rehabilitation program and (2) A greater increase in the implicit attitude score.
The primary objective will be to evaluate the effect of evaluative conditioning (EC) on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program.The secondary objective of this study will be to evaluate the mediating effect of implicit attitude change in the effect of evaluative conditioning on adopted behaviors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
More specifically, post-myocardial infarction physical activity has been shown to reduce cardiac morbidity and mortality. Indeed, exercise improves cardiovascular health through mechanisms such as lowering blood pressure, weight reduction, and increased insulin sensitivity. Although there are no formal guidelines for physical activity (PA) after Myocardial Infarction, patients are encouraged to achieve 150 minutes of low-to-moderate intensity PA per week.
Nevertheless, despite the growing body of scientific evidence and the widespread dissemination of information about the benefits of PA, the recommendations have been difficult for post-myocardial infarction patients to comply with. There is evidence to suggest that post-cardiac rehabilitation patients struggle to maintain sustained PA. This may be due to a number of barriers, including fatigue, mood disorders, a lack of motivation, or kinesiophobia.
Continued improvements in monitoring physical activity and the development of policies and programs to increase activity levels appears to be a necessity. This may reduce the burden of physical inactivity and noncommunicable diseases (eg, cardiovascular disease). Therefore, one of the major challenges is to succeed in identifying the main determinants playing a role in the lack of adoption of regular PA. Indeed, targeting these determinants would ultimately allow us to improve the PA promotion strategies already in place for the population. However, maintenance of a practice over time is a complex issue that may be influenced by a multitude of factors. Among these, previous work suggests that the identification of motivational determinants of physical activity represents a relevant research object in this context.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30900
- Centre Hospitalier Universitaire de Nimes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients must have given written informed consent to participate in the trial
- Patients must be aged18 to 75 years old
- It must be less than 6 months after a first episode of myocardial infarction treated medically or by revascularization
Exclusion Criteria:
- Patients with a disability preventing the performance of a bimanual test or an ergocycle task
- Patients who are unable to give written informed consent or who have refused to sign the consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diet group
Patients in this group will receive Evaluative Conditioning favorable to diet.
The evaluative conditioning procedure is a learning technique performed on a monitor.
It consists of being exposed to the repeated association of an object (conditioned stimulus; in this case, fruit and vegetables) to stimuli with a positive or negative valence (unconditioned stimulus).
The total duration of the Evaluative Conditioning is approximately 15 minutes.
|
The evaluative conditioning procedure is a learning technique performed on a monitor.
It consists of being exposed to the repeated association of an object (conditioned stimulus, in our case, Physical Activity or fruit and vegetables) to stimuli with a positive or negative valence (unconditioned stimulus, US).
The total duration of the CE is approximately 15 minutes.
|
|
Physical Activity group
Patients in this group will receive Evaluative Conditioning favorable to Physical Activity.
Patients in this group will receive Evaluative Conditioning favorable to diet.
The evaluative conditioning procedure is a learning technique performed on a monitor.
It consists of being exposed to the repeated association of an object (conditioned stimulus; in this case, Physical Activity) to stimuli with a positive or negative valence (unconditioned stimulus).
The total duration of the Evaluative Conditioning is approximately 15 minutes.
|
The evaluative conditioning procedure is a learning technique performed on a monitor.
It consists of being exposed to the repeated association of an object (conditioned stimulus, in our case, Physical Activity or fruit and vegetables) to stimuli with a positive or negative valence (unconditioned stimulus, US).
The total duration of the CE is approximately 15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of evaluative conditioning on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program. Control group
Time Frame: Day 0 before completing the Implicit Association Test
|
The choice of intensity (power setting) on the ergocycle will be measured by controlling it before the Evaluative Conditioning procedure.the
ergocycle task consists of pedaling on an indoor bicycle for about 15 minutes, we will only be interested in the intensity data of this task (This task is an integral part of the patients' care at the University Hospital and will be supervised by health professionals - physiotherapist, physical activity teachers, etc.)
|
Day 0 before completing the Implicit Association Test
|
|
Effect of evaluative conditioning on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program. Control group
Time Frame: Day 0 after completing the Implicit Association Test
|
The choice of intensity (power setting) on the ergocycle will be measured by controlling it before the Evaluative Conditioning procedure.the
ergocycle task consists of pedaling on an indoor bicycle for about 15 minutes, we will only be interested in the intensity data of this task (This task is an integral part of the patients' care at the University Hospital and will be supervised by health professionals - physiotherapist, physical activity teachers, etc.)
|
Day 0 after completing the Implicit Association Test
|
|
Effect of evaluative conditioning on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program. Experimental group
Time Frame: Day 0 before completing the Implicit Association Test
|
The choice of intensity (power setting) on the ergocycle will be measured by controlling it before the Evaluative Conditioning procedure.the
ergocycle task consists of pedaling on an indoor bicycle for about 15 minutes, we will only be interested in the intensity data of this task (This task is an integral part of the patients' care at the University Hospital and will be supervised by health professionals - physiotherapist, physical activity teachers, etc.)
|
Day 0 before completing the Implicit Association Test
|
|
Effect of evaluative conditioning on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program. Experimental group
Time Frame: Day 0 after completing the Implicit Association Test
|
The choice of intensity (power setting) on the ergocycle will be measured by controlling it before the Evaluative Conditioning procedure.
Note that the ergocycle task consists of pedaling on an indoor bicycle for about 15 minutes, (this task is an integral part of the patients' care at the University Hospital and will be supervised by health professionals - physiotherapist, physical activity teachers, etc.).
Only the intensity data of this task will be recorded
|
Day 0 after completing the Implicit Association Test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mediating effect of implicit attitudinal change in the effect of evaluative conditioning on adopted behaviors. Control group
Time Frame: Time 0, before taking the test
|
The change in implicit attitudes will be measured by comparing the Implicit Association Test pretest score (T0) and the Implicit Association Test posttest score (T1).
|
Time 0, before taking the test
|
|
Mediating effect of implicit attitudinal change in the effect of evaluative conditioning on adopted behaviors. Experimental group
Time Frame: Time 0, before taking the test
|
The change in implicit attitudes will be measured by comparing the Implicit Association Test pretest score (T0) and the Implicit Association Test posttest score (T1)
|
Time 0, before taking the test
|
|
Mediating effect of implicit attitudinal change in the effect of evaluative conditioning on adopted behaviors. Control group
Time Frame: Time 0, after taking the test
|
The change in implicit attitudes will be measured by comparing the Implicit Association Test pretest score (T0) and the Implicit Association Test posttest score (T1)
|
Time 0, after taking the test
|
|
Mediating effect of implicit attitudinal change in the effect of evaluative conditioning on adopted behaviors. Experimental group
Time Frame: Time 0, after taking the test
|
The change in implicit attitudes will be measured by comparing the Implicit Association Test pretest score (T0) and the Implicit Association Test posttest score (T1)
|
Time 0, after taking the test
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Rhodes RE, Janssen I, Bredin SSD, Warburton DER, Bauman A. Physical activity: Health impact, prevalence, correlates and interventions. Psychol Health. 2017 Aug;32(8):942-975. doi: 10.1080/08870446.2017.1325486. Epub 2017 May 30.
- Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.
- Karmali KN, Davies P, Taylor F, Beswick A, Martin N, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2014 Jun 25;(6):CD007131. doi: 10.1002/14651858.CD007131.pub3.
- Hamer M, O'Donovan G, Murphy M. Physical Inactivity and the Economic and Health Burdens Due to Cardiovascular Disease: Exercise as Medicine. Adv Exp Med Biol. 2017;999:3-18. doi: 10.1007/978-981-10-4307-9_1.
- Birtwistle SB, Jones I, Murphy R, Gee I, Watson PM. "Do what you can with a happy heart": a longitudinal study of patient and family members' lived experiences of physical activity post-myocardial infarction. Disabil Rehabil. 2022 Jul;44(14):3661-3670. doi: 10.1080/09638288.2021.1878560. Epub 2021 Mar 1.
- Antoniewicz F, Brand R. Learning to Like Exercising: Evaluative Conditioning Changes Automatic Evaluations of Exercising and Influences Subsequent Exercising Behavior. J Sport Exerc Psychol. 2016 Apr;38(2):138-48. doi: 10.1123/jsep.2015-0125. Epub 2016 Mar 15.
- Chevance G, Bernard P, Chamberland PE, Rebar A. The association between implicit attitudes toward physical activity and physical activity behaviour: a systematic review and correlational meta-analysis. Health Psychol Rev. 2019 Sep;13(3):248-276. doi: 10.1080/17437199.2019.1618726. Epub 2019 Jun 12.
- Rebar AL, Dimmock JA, Jackson B, Rhodes RE, Kates A, Starling J, Vandelanotte C. A systematic review of the effects of non-conscious regulatory processes in physical activity. Health Psychol Rev. 2016 Dec;10(4):395-407. doi: 10.1080/17437199.2016.1183505. Epub 2016 May 20.
- Hofmann W, De Houwer J, Perugini M, Baeyens F, Crombez G. Evaluative conditioning in humans: a meta-analysis. Psychol Bull. 2010 May;136(3):390-421. doi: 10.1037/a0018916.
- Rogerson MC, Murphy BM, Bird S, Morris T. "I don't have the heart": a qualitative study of barriers to and facilitators of physical activity for people with coronary heart disease and depressive symptoms. Int J Behav Nutr Phys Act. 2012 Nov 30;9:140. doi: 10.1186/1479-5868-9-140.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Local/2023/AP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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