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

Registry record from ClinicalTrials.gov (NCT07903025). This is a study registration, not published results. Lead sponsor: Axomove. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 184 participants (ESTIMATED). Conditions: Obese Adults. Interventions: DEVICE: Axomove Therapy; OTHER: Standard multidisciplinary medical care. Primary outcome measures: Distance walked in the 6-Minute Walk Test , At Month 0 = the patient's enrollment date (within a 2-week window prior to discharge from the hospital), and at Month 6 = 6 months (+/-15 days). Brief summary: 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.