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Completed

NCT Number: NCT04062929

Short Physical Activity Program in Coronary Artery Disease.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-day physical activity program with behavioral intervention

Behavioral

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.

Primary outcomes

  1. Change from Baseline BAPAC score at 3 months

    Time frame: Two administrations: at the entry in the program and after 3 months follow-up

    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)

Secondary outcomes

  1. Change from Baseline BAPAC score after the 4-day program

    Time frame: Two administrations: at the entry in the program and at the end of 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)

  2. Change from Baseline Dijon Physical Activity Score at 3 months

    Time frame: Two administrations: at the entry in the program and after 3 months follow-up

    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)

  3. BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)

    Time frame: Two administrations: at the entry in the program and at the end of the 4-day program; Calculation of the sensitivity to change

    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]).

  4. BAPAC sensitivity to change (the barriers to physical activity in CAD patients questionnaire, total score calculated over 55, with higher scores for higher barriers)

    Time frame: Two administrations: at the entry in the program andafter 3 months follow-up

    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]).

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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