Clinical trial NCT04062929: Short Physical Activity Program in Coronary Artery Disease.
Official title: Effectiveness of a Short Physical Activity Program on the Level and Barriers to Physical Activity in Individuals With Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Motivation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who participated to the 4-day program "Séjour tremplin: Activité physique et maladie cardiaque" for secondary prevention in cardiovascular disease, between January 2017 and October 2018

Brief summary: Coronary artery diseases (CAD) are multifactorial diseases which prognosis and risk factors are improved with increased physical activity (PA). Thus, CAD rehabilitation (CR) program is mainly based on recovering sufficient exercise capacity and promoting regular personalized PA associated to modifications in lifestyle habits to improve control of cardiovascular risk factors and health-related quality of life. However, most of patients do not achieve the recommended levels of PA which may be partly due to numerous barriers that hamper the return to a physically active lifestyle. One promising interventions strategy is so-called 'brief interventions' (BI) to increase PA in health care settings used to initiate change for an unhealthy behavior in individuals and consisting in "verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up". An 'extended brief intervention' (EBI) is similar but usually lasts more than 30 minutes and is delivered on a one-to-one or group basis and can be composed of multiple brief sessions. However, in CAD patients, the effect of such interventions on PA level and behavior remains unclear, as well as predictor patterns associated with better outcomes.

The investigators aimed to assess the effect of a 4-day PA education program with multiple EBI and exercise on the level and barriers to PA in CAD patients and characterize the profile of participants (barriers to PA) with better outcomes.


Eligibility criteria: Inclusion Criteria:

* age 18 years and older
* stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation.

Exclusion Criteria:

* Patients unable to give written constent
* Patients with impaired cognitive functions
* Patients with chronic motor deficiency or severe medical disorder (other than heart disease) significantly affecting functional abilities
* Patients with insufficient information about medical history of documented coronary disease

Primary outcomes:
measure: Change from Baseline BAPAC score at 3 months
timeFrame: Two administrations: at the entry in the program and after 3 months follow-up
Secondary outcomes:
measure: Change from Baseline BAPAC score after the 4-day program
timeFrame: Two administrations: at the entry in the program and at the end of the 4-day program
measure: Change from Baseline Dijon Physical Activity Score at 3 months
timeFrame: Two administrations: at the entry in the program and after 3 months follow-up
measure: BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)
timeFrame: Two administrations: at the entry in the program and at the end of the 4-day program; Calculation of the sensitivity to change
measure: BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)
timeFrame: Two administrations: at the entry in the program andafter 3 months follow-up
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References: