Coronary Artery DiseaseNCT04062929
Short Physical Activity Program in Coronary Artery Disease.
An observational study of Coronary Artery Disease and Motivation, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Motivation
- What is being tested?
- 4-day physical activity program with behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 15 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age 18 years and older
- stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Short Physical Activity Program on the Level and Barriers to Physical Activity in Individuals With 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.
- Conditions
- Coronary Artery Disease, Motivation
- Being tested
- 4-day physical activity program with behavioral intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-day physical activity program with behavioral interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The investigators included 32 patients who participated to a monocentric 4-day program for secondary prevention in cardiovascular disease, between January 2017 and October 2018. Participation to the program was on a voluntary basis and individuals were referred by their own physician, cardiac rehabilitation center or spontaneously. Eligibility criteria included age 18 years and older, stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation. Patients unable to give written constent, with impaired cognitive functions, chronic motor deficiency or severe medical disorder (other than heart disease) significantly affecting functional abilities and individuals with insufficient information about medical history of documented coronary disease were excluded. Receives: Behavioral: 4-day physical activity program with behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two administrations: at the entry in the program and after 3 months follow-up
Secondary outcomes (4)
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)
Measured: Two administrations: at the entry in the program and at the end of the 4-day program
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)
Measured: Two administrations: at the entry in the program and after 3 months follow-up
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]).
Measured: Two administrations: at the entry in the program and at the end of the 4-day program; Calculation of the sensitivity to change
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]).
Measured: Two administrations: at the entry in the program andafter 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Jan 2017
- Primary completion15 Oct 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062929
- Sponsor's protocol ID
- BAPAC II
- Status last verified
- Jun 2019
- First submitted
- 19 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Short Physical Activity Program on the Level and Barriers to Physical Activity in Individuals With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT04062929
- Acronym / sponsor ID
- BAPAC II
- Conditions
- Coronary Artery Disease, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: 4-day physical activity program with behavioral interventionThe investigators included 32 patients who participated to a monocentric 4-day program for secondary prevention in cardiovascular disease, between January 2017 and October 2018. Participation to the program was on a voluntary basis and individuals were referred by their own physician, cardiac rehabilitation center or spontaneously. Eligibility criteria included age 18 years and older, stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation. Patients unable to give written constent, with impaired cognitive functions, chronic motor deficiency or severe medical disorder (other than heart disease) significantly affecting functional abilities and individuals with insufficient information about medical history of documented coronary disease were excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- age 18 years and older
- stable coronary artery disease with appropriate medical certificate of fitness and no current medical conditions affecting sports participation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-day physical activity program with behavioral interventionEach 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. | Behavioural | Intervention |
Primary outcome
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)
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Motivation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline BAPAC score at 3 months (time frame: Two administrations: at the entry in the program and after 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.