Short Physical Activity Program in Coronary Artery Disease.

Coronary Artery Disease Clinical Trial

Official title:

Effectiveness of a Short Physical Activity Program on the Level and Barriers to Physical Activity in Individuals With Coronary Artery Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062929
• Other study ID #: BAPAC II
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 15, 2019
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Motivation
• Myocardial Ischemia

Intervention

Behavioral:
• 4-day physical activity program with behavioral intervention
Each program included 8-12 patients. During the four days, the participants had 4 collective sessions of educational information on PA and heart disease and 2 one-to-one sessions for promoting personal advice and experience on PA behavior. The participants had 6 sessions of PA and 2 food-counseling sessions.

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline BAPAC score at 3 months	Score on the the BAPAC questionnaire (the barriers to appropriate physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)	Two administrations: at the entry in the program and after 3 months follow-up
Secondary	Change from Baseline BAPAC score after the 4-day program	Score on the the BAPAC questionnaire (the barriers to appropriate physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)	Two administrations: at the entry in the program and at the end of the 4-day program
Secondary	Change from Baseline Dijon Physical Activity Score at 3 months	Score on the the Dijon Physical Activity Score (for quantifying the level of physical activity, score over 30 with higher scores for the most active individuals)	Two administrations: at the entry in the program and after 3 months follow-up
Secondary	BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)	Sensitivity to change of the BAPAC scale is calculated with the effect size (ES) and the standardized response mean (SRM). The minimal clinically important difference (MCID) of BAPAC change is calculated using an anchor-based approach calculating the threshold associated with better improvement on Dijon PAS levels (patient changing from low active [<20/30] to active levels [=20/30]).	Two administrations: at the entry in the program and at the end of the 4-day program; Calculation of the sensitivity to change
Secondary	BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)	Sensitivity to change of the BAPAC scale is calculated with the effect size (ES) and the standardized response mean (SRM). The minimal clinically important difference (MCID) of BAPAC change is calculated using an anchor-based approach calculating the threshold associated with better improvement on Dijon PAS levels (patient changing from low active [<20/30] to active levels [=20/30]).	Two administrations: at the entry in the program andafter 3 months follow-up