Obese AdultsON-TRACNCT07903025
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
A study testing Axomove Therapy and Standard multidisciplinary medical care in people with Obese Adults, run by Axomove at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese Adults
- What is being tested?
- Axomove Therapy and Standard multidisciplinary medical care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Oct 2026to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Clinique SMR Les Rosiers
Dijon
Caroline Prélot-Leguy, +33 826 30 50 05
Service Sport, Santé, Prévention, CHU Grenoble Alpes
Grenoble
Anne-Laure Borel, +33 4 76 76 55, alborel@chu-grenoble.fr
Anne-Laure Borel
CHU de Lille
Lille
Hélène VERKINDT, +33 3 20 44 42 73, helene.verkindt@chru-lille.fr
Hélène Verkindt
CHU de Nice
Nice
Nicolas CHEVALIER, PU-PH, +33 4 92 03 55 19, chevalier.n@chu-nice.fr
Nicolas CHEVALIER, PU-PH
Hôpital Européen Georges-Pompidou
Paris
Sébastien CZERNICHOW, PU-PH, +33 1 56 09 57 00, sebastien.czernichow@aphp.fr
Sébastien Czernichow
Centre Spécialisé de l'Obésité de Poitiers
Poitiers
Héléna Mosbah, +33 5 49 44 40 34, helena.mosbah@chu-poitiers.fr
Hélèna MOSBAH
SMR l'Alumnat
Scy-Chazelles
Isabelle Dedenon-Mayer, +33 3 87 60 31 11, isabelle.dedenon-mayer@ugecam.assurance-maladie.fr
Isabelle Dedenon-Mayer
Clinique les Peupliers
Villeneuve-d'Ascq, 59491
Barbara BERKHOUT, +33 3 20 05 70 00, b.berkhout@clinique-peupliers.com
About this study
Official title: Evaluation of the Impact of the Axomove Therapy Medical Device in Patients With Obesity to Facilitate Adapted Physical Activity
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.
Read more
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.
- Conditions
- Obese Adults
- Being tested
- Axomove Therapy, Standard multidisciplinary medical care
- Keywords
- Adapted Physical Activity (APA), Obesity, Medical Telemonitoring, Digital Medical Device, Treatment adherence
- Medical subject headings
- Obesity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axomove TherapyDevice
Also called Medical remote monitoring
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 careOther
Also called Conventional 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 group | Role | What they receive |
|---|---|---|
| Control arm: Conventional treatment for obesity | Active comparator | Standard multidisciplinary care for obesity in accordance with HAS recommendations, as well as a recommendation for adapted physical activity that can be done independently, a booklet of general exercises, and a referral to health and fitness facilities when appropriate. Receives: Other: Standard multidisciplinary medical care |
| Interventional arm: Conventional treatment + AXOMOVE THERAPY program | Experimental | Conventional multidisciplinary treatment for obesity in accordance with the HAS recommendations, supplemented by a tailored physical activity program prescribed and supervised via remote medical monitoring using the AXOMOVE THERAPY digital medical device for 6 months. Receives: Device: Axomove Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in the 6-Minute Walk Test
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.
Measured: 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)
Secondary outcomes (23)
Body weight
Weight is measured in kilograms (kg) using standard calibrated clinical scales across study sites.
Measured: 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)
Waist circumference
Waist circumference is measured in centimeters (cm) according to standardized clinical procedures across study sites.
Measured: 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)
Body composition
Body composition is assessed using bioimpedance analysis (BIA). The ratio is expressed as a unitless continuous variable, where a lower ratio indicates a higher proportion of muscle relative to fat mass (representing an improved body composition).
Measured: 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)
Level of physical activity
Physical activity levels will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The questionnaire evaluates the frequency and duration of vigorous activity, moderate activity, and walking over the past 7 days. Total physical activity is expressed as a continuous score in MET-minutes per week (ranging from 0 to unbounded, where higher scores indicate higher levels of physical activity). It also allows categorical classification into low (< 600 MET-min/week), moderate (600 to 2,999 MET-min/week), or high (≥ 3,000 MET-min/week) activity levels.
Measured: 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)
Pain
Pain will be assessed using the EVA pain scale, a visual analog scale ranging from 0 to 10 (from no pain to the worst pain imaginable).
Measured: 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)
Kinesiophobia
The TSK-17 (Tampa Scale for Kinesiophobia-17 items) assesses kinesiophobia, or the irrational fear of movement. It evaluates beliefs and attitudes related to movement, avoidance, and risk perception. The original version consists of 17 items (there is also a short 11-item version), using a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The higher the score, the greater the level of kinesiophobia (a score of 40/68 is considered indicative of significant kinesiophobia)
Measured: 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)
Health-Related Quality of Life in the context of obesity
Quality of life is assessed using the QOLOD (Quality of Life, Obesity, and Dietetics) test, which is recognized as a simple and reliable tool for specifically evaluating health-related quality of life in the context of obesity and dietary treatment in France, and is recommended for clinical practice by various healthcare professionals. The QOLOD scale consists of 36 items divided into 5 dimensions (physical, psychosocial, sexual life, dietary well-being, and experience with dietary treatment). Each question is rated on a Likert scale from 1 (Extremely/Always) to 5 (Not at all/Never). Scores are converted to percentages (0-100%), with higher scores indicating a better quality of life
Measured: 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)
Health-related quality of life
Health-related quality of life is evaluated using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument consists of two parts:
- EQ-5D-5L Descriptive System: Covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-point scale from 1 ("no problems") to 5 ("extreme problems"). These responses are converted into a single summary Index Score ranging from less than 0 (health state worse than death) to 1.000 (perfect health), where higher scores indicate a better health-related quality of life.
- EQ Visual Analog Scale (EQ-VAS): A continuous scale ranging from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"), where higher scores indicate a better self-rated overall health status.
Measured: 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)
Anxiety and depression
Anxiety and depression are assessed using the HAD (Hospital Anxiety and Depression Scale). It is a self-report scale designed to screen for anxiety and depression in hospitalized or outpatient patients. It consists of 14 items divided into two subscales: anxiety (HAD-A) and depression (HAD-D), each comprising seven questions. Each item is scored on a scale of 0 to 3, resulting in a subscale score ranging from 0 to 21. A score of 0 to 7 is considered normal, 8 to 10 is considered borderline, and a score of 11 or higher is considered indicative of a probable disorder.
Measured: 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)
Patient confidence
Patient confidence level regarding their ability to perform adapted physical activity is evaluated using a subjective questionnaire scored on a 5-point Likert scale. Scores range from 1 (very low confidence / strongly disagree) to 5 (very high confidence / strongly agree), where higher scores indicate greater patient confidence and self-efficacy.
Measured: 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)
Patient adherence to prescribed exercise program
Patient adherence to the prescribed home-based Adapted Physical Activity (APA) exercise program will be evaluated in the interventional group using a self-reported electronic outcome questionnaire (ePRO). Adherence is measured as the percentage of prescribed exercise sessions completed by the patient over the 6-month period, ranging from 0% to 100%, where higher percentages indicate greater adherence. Patients achieving an adherence rate > 30% are considered adherent (adherence ≤ 30% triggers an automated clinical alert).
Measured: At Month 6 = 6 months (+/- 15 days)
The resort to a co-intervention
The number and type of each co-intervention (medical, paramedical)
Measured: Between Month 0 and Month 6 (±15 days)
Number and duration of work absences
Organizational impact is evaluated by tracking the total number of work absence episodes and cumulative duration of work absences (expressed in days) per participant between discharge from the rehabilitation center (Month 0) and Month 6.
Measured: Between Month 0 and Month 6 (±15 days)
Number of unscheduled medical consultations
Organizational impact is evaluated by tracking the number of unscheduled outpatient medical consultations per participant between discharge from the rehabilitation center (Month 0) and Month 6.
Measured: Between Month 0 and Month 6 (±15 days)
Number of unscheduled hospitalizations
Organizational impact is evaluated by tracking the number of unscheduled hospital admissions per participant between discharge from the rehabilitation center (Month 0) and Month 6.
Measured: Between Month 0 and Month 6 (±15 days)
Number of Adapted Physical Activity (APA) and physical therapy sessions
Organizational impact is evaluated by tracking the total number of Adapted Physical Activity (APA) and physical therapy (physiotherapy) sessions completed per participant between discharge from the rehabilitation center (Month 0) and Month 6.
Measured: Between Month 0 and Month 6 (±15 days)
Overall cost of healthcare utilization per participant
Health economics assessment calculating the overall total cost of care per participant (expressed in Euros ) from baseline to Month 6. This includes direct medical costs (hospitalizations, outpatient consultations, prescribed medications, physical therapy/APA sessions, complementary medicine) and indirect costs (sick leave duration) evaluated across all healthcare components.
Measured: Between Month 0 and Month 6 (±15 days)
Patient Out-of-Pocket Expenses
Health economics assessment calculating the average out-of-pocket costs (personal financial contribution expressed in Euros [EUR]) incurred per participant for healthcare services and co-interventions between baseline and Month 6.
Measured: Between Baseline (Month 0) and Month 6 (±15 days)
Incremental cost difference between study Arms
Health economics assessment calculating the mean incremental cost difference (expressed in Euros ) per participant between the interventional group (AXOMOVE THERAPY plus standard care) and the control group (standard care alone) at Month 6 from the perspectives of the National Health Insurance and the overall healthcare system.
Measured: At Month 6 (±15 days)
Patient's usability of AXOMOVE THERAPY
Patient's usability of the AXOMOVE THERAPY will be assessed among participants in the experimental group using the French version of the System Usability Scale (SUS) questionnaire at the end of the study. The questionnaire consists of 10 items, each scored on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). The overall SUS score ranges from 0 to 100, where higher scores indicate higher usability.
Measured: At Month 6 (±15 days)
Healthcare professional's usability of AXOMOVE THERAPY®
Healthcare professional's usability of the AXOMOVE THERAPY will be assessed among healthcare providers involved in the experimental group using the French version of the System Usability Scale (SUS) questionnaire at the end of the study. The questionnaire consists of 10 items, each scored on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 ( Strongly agree). The overall SUS score ranges from 0 to 100, where higher scores indicate higher usability.
Measured: At Month 6 (±15 days)
Patient's satisfaction with AXOMOVE THERAPY
Patient's satisfaction with the AXOMOVE THERAPY will be assessed among participants in the experimental group using a study-specific electronic questionnaire (ePRO) completed at the end of the study. Items are scored on a 5-point Likert scale ranging from 1 ("Very dissatisfied" / "Strongly disagree") to 5 ("Very satisfied" / "Strongly agree"). The questionnaire evaluates overall patient satisfaction, perceived clinical benefit, clarity of video exercises, ease of remote support, and overall user experience with the digital physical activity program.
Measured: At Month 6 (±15 days)
Healthcare Professional's Satisfaction with AXOMOVE THERAPY
Healthcare professional's satisfaction with the AXOMOVE THERAPY will be assessed among healthcare providers involved in the experimental group using a study-specific questionnaire completed at the end of the study. Items are scored on a 5-point Likert scale ranging from 1 ("Very dissatisfied" / "Strongly disagree") to 5 ("Very satisfied" / "Strongly agree"). The questionnaire evaluates overall satisfaction, clinical utility, user interface ergonomics, and integration of the telemonitoring dashboard and automated alert management system into routine care workflows.
Measured: At Month 6 (±15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axomove
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas CHEVALIER, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903025
- Sponsor's protocol ID
- 2026-A01348-43
- Acronym
- ON-TRAC
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Axomove Therapy Medical Device in Patients With Obesity to Facilitate Adapted Physical Activity
- ClinicalTrials.gov ID
- NCT07903025
- Acronym / sponsor ID
- ON-TRAC / 2026-A01348-43
- Conditions
- Obese Adults
- Keywords
- Adapted Physical Activity (APA), Obesity, Medical Telemonitoring, Digital Medical Device, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- AxomoveIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm: Conventional treatment for obesity | Active comparator | Other: Standard multidisciplinary medical careStandard multidisciplinary care for obesity in accordance with HAS recommendations, as well as a recommendation for adapted physical activity that can be done independently, a booklet of general exercises, and a referral to health and fitness facilities when appropriate. |
| Interventional arm: Conventional treatment + AXOMOVE THERAPY program | Experimental | Device: Axomove TherapyConventional multidisciplinary treatment for obesity in accordance with the HAS recommendations, supplemented by a tailored physical activity program prescribed and supervised via remote medical monitoring using the AXOMOVE THERAPY digital medical device for 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axomove TherapyAlso: Medical remote monitoringThe 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. | Device | Interventional arm: Conventional treatment + AXOMOVE THERAPY program |
| Standard multidisciplinary medical careAlso: Conventional CareThe 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. | Other | Control arm: Conventional treatment for obesity |
Primary outcome
Distance walked in the 6-Minute Walk Test
Time frame: 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.
23 secondary outcomes
Body weight
Time frame: 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)
Waist circumference
Time frame: 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)
Body composition
Time frame: 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)
Level of physical activity
Time frame: 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)
Pain
Time frame: 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)
Kinesiophobia
Time frame: 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)
Health-Related Quality of Life in the context of obesity
Time frame: 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)
Health-related quality of life
Time frame: 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)
Anxiety and depression
Time frame: 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)
Patient confidence
Time frame: 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)
Patient adherence to prescribed exercise program
Time frame: At Month 6 = 6 months (+/- 15 days)
The resort to a co-intervention
Time frame: Between Month 0 and Month 6 (±15 days)
Number and duration of work absences
Time frame: Between Month 0 and Month 6 (±15 days)
Number of unscheduled medical consultations
Time frame: Between Month 0 and Month 6 (±15 days)
Number of unscheduled hospitalizations
Time frame: Between Month 0 and Month 6 (±15 days)
Number of Adapted Physical Activity (APA) and physical therapy sessions
Time frame: Between Month 0 and Month 6 (±15 days)
Overall cost of healthcare utilization per participant
Time frame: Between Month 0 and Month 6 (±15 days)
Patient Out-of-Pocket Expenses
Time frame: Between Baseline (Month 0) and Month 6 (±15 days)
Incremental cost difference between study Arms
Time frame: At Month 6 (±15 days)
Patient's usability of AXOMOVE THERAPY
Time frame: At Month 6 (±15 days)
Healthcare professional's usability of AXOMOVE THERAPY®
Time frame: At Month 6 (±15 days)
Patient's satisfaction with AXOMOVE THERAPY
Time frame: At Month 6 (±15 days)
Healthcare Professional's Satisfaction with AXOMOVE THERAPY
Time frame: At Month 6 (±15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas CHEVALIER principal investigator
Centre Hospitalier Universitaire de Nice
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axomove Therapy and Standard multidisciplinary medical care in people with Obese Adults, run by Axomove at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poupard Lucie (+33 6 75 38 53 54, lucie.poupard@axomove.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked in the 6-Minute Walk Test (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.