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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)
  The 6-Minute Walk Test is the most commonly used test to assess functional capacity. It will be administered by trained healthcare personnel (other than the investigator). It is performed over a distance of at least 30 meters on a flat surface. Each patient will receive the same instructions to walk as far as possible for 6 minutes, with the option to walk back and forth along this corridor. The outcome measure reports the total distance walked (expressed in meters) over 6 minutes. Measurements will be taken using the same device, following the same procedure. The test should preferably be conducted in the morning or, if not possible, always at the same time of day for the same participant. Participants must wear comfortable clothing and shoes suitable for walking. Standard walking aids (canes, walkers, etc.) may be used if necessary.

Trial sites (8)