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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Planned participants: 184
• From 1 Oct 2026 to the primary completion date, 15 Apr 2028
• 8 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

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