Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity

Background: Obesity affects 18.1% of adults in France and leads to numerous chronic complications as well as functional limitations (fatigability, dyspnea). While Adapted Physical Activity (APA) is an essential first-line intervention, maintaining independent adherence after discharge from a rehabilitation center remains a major challenge. The use of remote medical monitoring via digital medical devices provides asynchronous, personalized, and secure follow-up to optimize this transition. Objective: The objective of the ON-TRAC study is to demonstrate the superiority of adding the remote medical monitoring device AXOMOVE THERAPY® compared to conventional care alone in improving the cardiorespiratory and functional capacities of patients with obesity at 6 months. Methods: In the context of this interventional, prospective, multicenter, controlled, randomized (1:1 ratio, stratified by center), single-blind clinical study, 184 patients (92 per arm) will be included over a 6-month follow-up period. Control Group (CG) (N=92): Will receive conventional multidisciplinary care (HAS recommendations) combined with a recommendation for independent APA and the provision of a generic exercise booklet. Interventional Group (IG) (N=92): Will receive the same conventional care, supplemented by a personalized APA program prescribed, guided, and supervised remotely via the AXOMOVE THERAPY® medical device, which includes an automatic alert system in case of pain, difficulty, or decreased adherence. Outcomes: The primary endpoint is the change in distance covered during the 6-minute walk test (6MWT) between inclusion (M0) and the end of follow-up (M6), evaluated in a standardized manner by blinded healthcare staff. The secondary endpoints include: Changes in weight, waist circumference, BMI, fat/muscle mass ratio, and the percentage of patients losing ≥ 5% of their body weight at 6 months. Physical activity level (IPAQ-SF), pain intensity (VAS), fear of movement (TSK-17). Impact on global and specific quality of life (QOLOD, EQ-5D-5L). Self-confidence and anxiety/depression levels (HADS). Adherence and use of co-interventions (APA sessions, physiotherapy). Duration of sick leave, and the number of unscheduled consultations or hospitalizations. Economic evaluation: overall cost of care, expenses reimbursed by the National Health Insurance (Assurance Maladie), and out-of-pocket costs for patients. Usability, satisfaction, and safety (evaluated for IG patients only). Timeline: The total planned duration for this study is 18 months, including 12 months of recruitment and a follow-up of 6 to 6.5 months per participant.

Inclusion Criteria: * Patient aged between 18 and 65 years. * Patient with obesity (BMI ≥ 30 kg/m²), followed in a day hospital, weekday hospital, or full hospitalization, with a planned return home within 2 weeks following the inclusion visit (V0 between Day-14 and Day 0 before the hospital discharge date), regardless of the referral pathway (Specialized Obesity Center, general practitioner, cardiologist, etc.). * Patient requiring, according to the investigator's assessment, an adapted physical activity (APA) program for a duration of 6 months. * Patient having provided and signed informed consent. * Patient owning a smartphone, tablet, or computer (compatible with the medical device's technical requirements) and having the ability to connect to the internet (via a mobile data plan or Wi-Fi connection). * Patient agreeing to install the application and to comply with the study protocol. * Patient affiliated with or benefiting from a national health insurance scheme (social security). Non-Inclusion Criteria: * Patient having undergone bariatric surgery less than one year ago OR Patient for whom bariatric surgery is planned within 6 months following inclusion. * Patient who initiated a GLP-1 agonist treatment\* less than one year ago, regardless of the indication, OR Patient for whom a GLP-1 prescription is planned within 6 months following inclusion. (A dose modification within the last 12 months will not be considered a non-inclusion criterion). * Patient unable to understand, read, or speak French. * Patient with non-stabilized psychiatric disorders preventing the autonomous execution of exercises, according to the investigator's judgment. * Pregnant, parturient, or breastfeeding patient. * Patient under legal protection (guardianship, curatorship). * Patient presenting with a severe and/or uncontrolled disease for which, in the investigator's opinion, practicing adapted physical activity could lead to unacceptable safety risks or compromise protocol compliance (e.g., active or uncontrolled infection). * Patient presenting with a sensory, visual, or tactile impairment preventing the proper use of a smartphone, tablet, and/or computer, or preventing the safe and proper execution of the exercises. * Patient presenting with a cognitive disorder that severely limits their concentration capacity, thereby preventing the proper use of a smartphone, tablet, and/or computer.