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NCT07903025

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

Sponsor: Axomove

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Impact of the Axomove Therapy Medical Device in Patients With Obesity to Facilitate Adapted Physical Activity

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2026-10-01

Completion Date

2028-04-15

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Obese Adults

Interventions

DEVICE

Axomove Therapy

The intervention is based on a model that combines conventional obesity management with an individualized, self-directed Adapted Physical Activity (APA) program that is remotely monitored for 6 months via the AXOMOVE THERAPY® digital medical device. The protocol begins with an inpatient initiation phase that includes the collection of assessment data (anthropometry, blinded TM6, PAQ-SF, EVA, TSK-17, QOLOD, EQ-5D-5L, HAD) and two sessions with a healthcare provider to train the patient and calibrate their program. This is followed by a 6-month phase of performing active physical therapy at home, at a rate of three 20-minute sessions per week, coupled with systematic reporting of perceived intensity and pain. This data feeds into active remote monitoring with alert management, allowing healthcare providers to readjust the program or schedule a consultation if necessary. Finally, at the 6-month mark, clinical, functional, and usability metrics are collected.

OTHER

Standard multidisciplinary medical care

The intervention for the control group begins with an inpatient initialization phase identical to that of the intervention group, combining a comprehensive assessment and the collection of outcome measures (anthropometry, blinded TM6, PAQ-SF, VAS, TSK-17, QOLOD, EQ-5D-5L, HAD) and the provision of a printed booklet containing general physical exercise recommendations. This is followed by a 6-month phase of independent practice at home, during which the patient receives standard multidisciplinary care (medical, dietary, psychological) and engages in physical activity entirely on their own using their booklet, without access to the AXOMOVE THERAPY® . Finally, a 6-month evaluation is conducted, including a collection of clinical, functional, and healthcare utilization data to enable comparison with the intervention arm.

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.

Locations (8)

Clinique SMR Les Rosiers

Dijon, France

Service Sport, Santé, Prévention, CHU Grenoble Alpes

Grenoble, France

CHU de Lille

Lille, France

CHU de Nice

Nice, France

Hôpital Européen Georges-Pompidou

Paris, France

Centre Spécialisé de l'Obésité de Poitiers

Poitiers, France

SMR l'Alumnat

Scy-Chazelles, France

Clinique les Peupliers

Villeneuve-d'Ascq, France