Health-Enhancing Adapted Physical Activity Program at "Mon Stade"
Health-Enhancing Adapted Physical Activity Program at "Mon Stade"
Introduction: Regular practice of exercise or physical activity (PA) is a recognized
 intervention as a determinant of good health acquisition, maintenance, or recovery for a
 large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an
 initial health-adapted PA (APA) program, and persistence of active behavior over the time in
 individuals with a chronic disease.

 The aim of the study is to determine the brakes and levers associated with motivation and
 long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness
 of such program in term of care consumption. Finally, the investigators complete their
 interest for APA prescription from practitioners agreeing to enroll their patients in the
 present study.

 Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected
 of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per
 year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of
 life and care consumption evaluation.
Background:

 While physical inactivity is the first modifiable risk factor (2nd is tobacco consumption)
 for cardiovascular morbidity and mortality and cancer in the World, regular physical activity
 (PA) is a recognized intervention with a high level of evidence, as a key determinant of good
 health acquisition, maintenance, or recovery for a large number of chronic pathologies.

 The following 3 points caught the investigators' interest:

 Point n°1: The 2019 collective expertise of the French National Institute of Health and
 Medical Research (INSERM) "Physical Activity: Prevention and Treatment of Chronic Diseases"
 reported following findings on the motivational aspects of regular or non-regular PA practice
 by people suffering from a chronic disease: 1) people with chronic disease practice less than
 the general population of the same age; 2) a significant number of patients do not
 participate in the proposed PA programs, and high drop-out rates are reported during these
 programs; 3) only a small percentage of patients maintain PA after completion of these
 programs. However, there is a lack of evidence and inconsistent quality studies regarding
 changes in duration of behavior following PA intervention programs. Follow-up of behavioral
 changes beyond 2 years is extremely rare in the literature. Thus, the problem is of a
 behavioral nature: on one hand, whether or not a person with a chronic disease adheres to an
 initial health-adapted PA program (APA), and on the other hand, whether or not a PA practice
 persists or is maintained over time. The identification of barriers and levers is key to help
 define actionable means to support adherence and enhance the sustainability of the virtuous
 behavior change induced by an initial program. This need for studies is underlined by "The
 group of experts [from INSERM, which] recommends: 1) long-term intervention studies with
 supervised exercises and 2) long-term post-intervention follow-up in order to better evaluate
 the continuation of program practice in autonomy", but also "to promote research on
 motivation and long-term compliance".

 Point n°2: In relation to the benefit of PA programs on the physical and psycho-social
 fitness of individuals, the effects on health are demonstrated. As a result, a decrease in
 the prevalence of health events and their complications can be observed, as well as a more
 detailed use of care (drug treatment, consultations, and hospitalizations) depending on
 whether or not the participant benefits from an APA intervention. The medico-economic impact
 of such APA intervention has been little studied. Thus, the problem is of a medico-economic
 nature: the interest will initially focus on the evolution of care pathways over time, and
 the differences observed according to pathologies, but also according to the participants'
 behavior, in terms of compliance, or persistence or not in the duration of the favorable
 change in behavior initially acquired. An evaluation of care consumption and care pathways
 according to whether individuals have benefited from an APA program as proposed (SESAME
 cohort) or not (controls) also appears justified and will come later. This need for studies
 is emphasized by the INSERM expert group, which recommends "evaluating the cost-effectiveness
 of interventions according to the technique(s) used".

 Point n°3: While the attending physician can prescribe an APA program to his patients with a
 chronic disease through a list of 30 long-term illness (LTI), (Article L. 1172-1 of the
 French Public Health Code and Decree N° 2016-1990 of December 30, 2016), the practitioner is
 confronted on the one hand with chronic pathologies outside of LTI list for which APA
 provides a demonstrated benefit (arterial hypertension (HTN), obesity, chronic obstructive
 pulmonary disease (COPD)), and on the other hand with a lack of experience in this
 non-medicinal prescription. Thus, the problem is of an operational practical nature in the
 prescription of APA, with a need for collection and analysis of the brakes and levers that
 can be applied to the prescription of APA, and for training and coordination of medical
 actors with APA professional. This need is underlined by the INSERM expert group, which
 recommends "the development of exchanges and joint reflection between the different
 professions involved in favor of the practice of APA."

 Objectives:

 In view of all these elements, the SESAME project consists in the prospective constitution of
 a cohort of people affected by a chronic pathology and enrolled in a 16-week individualized,
 educational and structured APA program, with a 5-year follow-up, providing support for an
 observational study whose main objective is the behavioral analysis of the brakes and levers
 associated with the persistence over time of a favorable change in behavior induced by an
 initial APA program.

 Secondary objectives are: 1) an analysis of the effects of the program on the physical and
 psychological fitness parameters; 2) a behavioral analysis of the brakes and levers
 associated with good adherence to the initial APA program; 3) a medico-economic analysis: a)
 volume-based care consumption analysis: monitoring the evolution of the participants' care
 pathway and care consumption over time; b) cost analysis: expressing care consumption in
 monetary units; c) budget impact analysis: estimating the difference in costs between the
 "APA strategy" for SESAME participants and the "usual care strategy" of members of the French
 health insurance "Mutuelle Générale de l'Education Nationale" (MGEN) with comparable
 characteristics in terms of age and gender and belonging to the following subgroups; 4) an
 analysis of the practice of prescribing APA among physicians, and their brakes and levers for
 such a prescription.

 Methods:

 Prospective and consecutive constitution of a monocentric cohort, for the behavioral and
 medico-economic analysis of the effects of a non-medicinal intervention by the APA (qualified
 as a research involving the human person type 2 "RIPH 2" within the meaning of article L.
 1121-1 of the French Public Health Code).

 Duration of the inclusion period: 4 years Duration of follow-up for the participant: 5 years
 Number of visits for participant: 7 (Inclusion; end of 48 sessions of APA program over 16
 weeks (maximum 9 months from start); at 1 year; 2 years; 3 years; 4 years and 5 years) Number
 of participants: 2024 (506 per year) Due to the lack of behavioral studies in population of
 individuals with a chronic condition for which the benefit of APA has been demonstrated, the
 number of subjects required cannot be calculated. Given the experience of a 1st pilot cohort
 of 600 people with chronic pathologies (including obesity) treated with support from the
 Regional Health Agency (ARS) Île-de-France in 2014-2016, a number of 2024 people for the
 constitution of the SESAME cohort is feasible, with a recruitment of 506 participants per
 year for 4 years.

 The participants will be recruited consecutively according to the terms of the French Law
 (Decree n°2016-19990 of 30 Dec 2016, entered into application on 01 March 2017) relating to
 the conditions of dispensation of APA prescribed by the attending physician to patients
 suffering from LTI. For the study, the pathology criteria are extended to chronic pathologies
 outside 30-LTI list for which the benefit of APA has been demonstrated with a high level of
 evidence (grade A) including, among others, obesity, HTN, COPD, as well as to the sequelae of
 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the context of
 coronavirus 2019 disease (COVID-19). According to the prescription of his doctor, the patient
 will go to "Mon Stade" Sport Medicine Center, and will benefit from inclusion in the program.

 The measurements, collections, health examinations and follow-up of the participants will be
 carried out by the personnel of "Mon Stade" (doctors and physical preparers/teachers in APA,
 APA master trainees and doctoral students, administrative or paramedical agents) according to
 their fields of competence and prerogatives. They will receive a specific training on how to
 pass questionnaires and tests in order to standardize data collection and to know the course
 of care for these evaluations.

 The APA program has been established according to a standardized, homogenous, shared and
 coordinated practice protocol by all the operators, for each stage of the course: inclusion
 of the participant, initial evaluation, design, supervision and monitoring of the training
 plan, and final evaluation. The 16-week program consists of 3 sessions per week, including 2
 supervised sessions with individualized educational follow-up by a physical trainer (MSc
 Sport Sciences, specialized in APA) at "Mon Stade", and 1 session in autonomy (can be done at
 home). Each session includes: a warm-up phase with articular and muscular awakening carried
 out autonomously; a 1-hour session bodywork combining 25 minutes of interval aerobic
 exercises (split type) and 25 minutes of neuromuscular reinforcement in circuit. The
 intensities and modalities of the exercises will have been personalized according to the
 results of the initial fitness assessment.

 Regarding the behavioral analysis, the characteristics of physical and mental condition,
 quality of life and behavior will be observed as a function of time, and compared according
 to the following subgroups: 1) General characteristics: gender, age group, body mass index
 (BMI), socioeconomic category, childhood lifestyle habits, history of participation in an APA
 program; 2) Chronic disease groups for inclusion: metabolic (obesity, diabetes);
 cardiovascular-renal (HTN, coronary artery disease, heart failure, arteritis, stroke, kidney
 disease); respiratory (COPD, asthma, cystic fibrosis); oncological (solid and non-solid
 neoplasia); neurological (epilepsy, Parkinson's, Alzheimer's); psychiatric (depressive
 syndrome, bipolarity, schizophrenia); osteoarticular (chronic low back pain, chronic
 inflammatory rheumatism, arthritis, osteoporosis); infectious (human immunodeficiency virus
 (HIV), viral hepatitis C, SARS-CoV-2); 3) Observer" vs. "non-observer" status in the initial
 APA program, with collection of data on program attendance, the number of sessions carried
 out in a supervised manner at "Mon Stade" or independently (declarative), the actual duration
 of the program, and the reasons for its possible interruption ("Observers" = ≥90% completion
 of the 2 weekly supervised sessions of the initial APA program over a period of 4 to 9
 months); 4) "Persistent" vs. "Non-persistent" status at 1, 2, 3, 4 and 5 years regarding the
 favorable behavior change initially acquired ("Persistent" = participants with a positive
 trajectory of the percentages of "moderate to vigorous" PA collected each year by wearing an
 accelerometer over 7 days).

 Medico-economic analysis includes: 1) an analysis of care consumption by volume (consumption
 and care pathway over time); comparison by subgroups of participants; 2) a cost analysis;
 average cost by subgroups of participants compared to overall cost; 3) a budget impact
 analysis by estimating the difference in costs between SESAME participants and MGEN members
 with comparable age and gender characteristics who follow the usual care strategy among LTI,
 hypertensive, and obese patients.

 Analysis of APA prescribing practice includes: 1) a phase of identification of potential
 prescribing practitioners from Parisian centers likely to refer patients; 2) an analysis of
 the general characteristics of practitioners, as well as their PA level by questionnaire; 3)
 an analysis of their barriers and levers to the practice of PA; 4) an analysis of their
 barriers and levers to the prescription of APA with a questionnaire dedicated to this
 objective; 5) the participatory development of the prescription and patient follow-up tools.
Inclusion Criteria:

 -  Male or female

 -  18 years of age or older

 -  Speaking and understanding French

 -  Affected by a chronic pathology according to a predefined list (LTI, obesity, HTA,
 COPD, COVID-19 with persistent symptoms)

 -  Carrier of a writing APA prescription

 -  Able to come to "Mon Stade" twice a week for their APA sessions following the 16-week
 health-adapted PA program;

 -  Signature of the information and consent form.

 Exclusion Criteria:

 - Women whose pregnancy is known