Evolution of Cardiovascular Function and Quality of Life in Patients Included in the SCArabée Therapeutic Education Program
Study Details
Study Description
Brief Summary
Coronary artery disease is defined as a disease of the arteries that vascularize the heart, resulting in myocardial ischemia, i.e. insufficient blood supply to the heart muscle. Eventually, it may be responsible for acute coronary syndrome that includes unstable angina (chest pain) and myocardial infarction (necrosis of the heart muscle).
The main cause of this disease is atheroma, and management involves reducing modifiable cardiovascular risk factors (sedentary lifestyle, smoking, obesity, high blood pressure, diabetes, dyslipidemia). Every year, this disease affects more than 120 000 people in France, aging 65 years on average.
In this real public health problem, there is a significant discrepancy between the excellence of the management of the acute incident and the inadequacy of the re-adaptive and educational management of the care suites. In fact, it is noted that hospitalization times are short given the progress of myocardial revascularization, associated with a low intra-hospital mortality rate, 3% but the places in rehabilitation programs ("Soins de Suite et de Réadaptation" or "SSR") are too limited (25% of the patients are included in these programs). Physical rehabilitation has proven effective for decades, with robust evidence of decreased recurrence and mortality (-20%).
At the Groupe Hospitalier Mutualiste of Grenoble, France, patients are offered two courses of treatment in post-myocardial infarction:
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A therapeutic education program: SCarabée,
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A rehabilitation program (SSR) The therapeutic education program aims to help the patient identify his needs, acquire knowledge, strengthen his resources and finally develop with him a project to improve his quality of life.
SSR offers physical rehabilitation as a treatment for infarction, which improves cardiovascular function, which is assessed by the cardiorespiratory test.
Is the Scarabée therapeutic education program is sufficient to help the patient improve his physical abilities? This study aims to answer this question, by setting up a reinforced monitoring of the evolution of the cardiovascular function of the patients included in the SCArabée program, via cardiorespiratory tests. The results of this first pilot study will potentially lead to a second randomized study comparing therapeutic education associated with Adapted Physical Education versus therapeutic education alone for the improvement of cardiorespiratory functions and the quality of life of these patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cardiac stress test
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Diagnostic Test: Cardiac stress test
In order to assess the evolution of their cardiorespiratory function, patients will benefit from two cardiac stress test combined with VO2 study, one at inclusion in the study, and the other one 6 months later.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Assess the evolution of cardiovascular function of patients included in the SCArabée program [At inclusion, and 6 month after inclusion]
Endpoint : Percentage change in the VO² threshold between the two cardiac stress tests
Secondary Outcome Measures
- Assess the evolution of the patient's physical activity [At inclusion, and 6 month after inclusion]
Endpoint : Score of the "Ricci and Gagnon" questionnaire filled by the patient
- Assess the evolution of cardiac function [At inclusion, and 6 month after inclusion]
Endpoint : Left Ventricular Ejection Fraction measured during the two cardiac stress tests
- Assess the evolution of perceived level of anxiety [At inclusion, and 6 month after inclusion]
Endpoint : Score of the Hospital Anxiety and Depression Scale filled by the patient
- Assess the evolution of global quality of life [At inclusion, and 6 month after inclusion]
Endpoint : Score of the 12-Item Short Form Health Survey (SF-12) filled by the patient
- Assess the evolution of weight [At inclusion, and 6 month after inclusion]
Measured during a bioelectrical impedance analysis
- Assess the evolution of fat mass [At inclusion, and 6 month after inclusion]
Measured during a bioelectrical impedance analysis
- Assess the evolution of visceral fat mass [At inclusion, and 6 month after inclusion]
Measured during a bioelectrical impedance analysis
- Assess the evolution of muscular mass [At inclusion, and 6 month after inclusion]
Measured during a bioelectrical impedance analysis
- Assess the evolution of Body Mass Index [At inclusion, and 6 month after inclusion]
- Assess the evolution of tobacco consumption [At inclusion, and 6 month after inclusion]
Comparison of the number of cigarettes consumed per day between the month preceeding the Acute Coronary Syndrome event and the 6th month of follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged 18 or older
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Patient with newly diagnosed or recurring Acute Coronary Syndrome, or presenting a coronary heart disease detected on ischemia test and stented
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Patient included in the SCArabée therapeutic education program
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Patient assessed stable on the basis of a clinical examination, or exercise test, or ultrasound data
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Patient in physical capacity to perform a cardiorespiratory test
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Patient giving free, informed and written consent
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Patient affiliated to the social security system
Exclusion Criteria:
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Impossibility to submit to follow-up of the study for geographical social or psychological reasons
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Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (corresponds to all persons protected): pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person making the subject of a legal protection measure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Mutualiste de Grenoble | Grenoble | France | 38028 |
Sponsors and Collaborators
- Groupe Hospitalier Mutualiste de Grenoble
- Fondation de l'Avenir
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- Kotseva K, De Bacquer D, De Backer G, Rydén L, Jennings C, Gyberg V, Abreu A, Aguiar C, Conde AC, Davletov K, Dilic M, Dolzhenko M, Gaita D, Georgiev B, Gotcheva N, Lalic N, Laucevicius A, Lovic D, Mancas S, Miličić D, Oganov R, Pajak A, Pogosova N, Reiner Ž, Vulic D, Wood D, On Behalf Of The Euroaspire Investigators. Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. Eur J Prev Cardiol. 2016 Dec;23(18):2007-2018. doi: 10.1177/2047487316667784. Epub 2016 Sep 27.
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- Pavy B, Barbet R, Carré F, Champion C, Iliou MC, Jourdain P, Juillière Y, Monpère C, Brion R; Working Group of Exercise Rehabilitation and Sport; Therapeutic Education Commission of the French Society of Cardiology. Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology. Arch Cardiovasc Dis. 2013 Dec;106(12):680-9. doi: 10.1016/j.acvd.2013.10.002. Epub 2013 Nov 15. Review.
- Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34.
- Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.
- Wasserman K, Hansen JE, Sue DY, Whipp BJ, Froelicher VF. Principles of Exercise Testing and Interpretation. Journal of Cardiopulmonary Rehabilitation and Prevention. avr 1987;7(4):189.
- Wilmore JH, Costill DL, Kenney L. Physiologie du sport et de l'exercice. De Boeck Superieur; 2017. 644 p.
- Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.
- 2018/06-JPE-GHMG