An interventional study of Axomove Therapy and Standard multidisciplinary medical care in Obese Adults, sponsored by Axomove. Not yet recruiting at 8 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Axomove · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 184 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Axomove is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non-Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Standard multidisciplinary medical care
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.
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.
Also known as: Medical remote monitoring
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.
Also known as: Conventional Care
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.
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 weight
Weight is measured in kilograms (kg) using standard calibrated clinical scales across study sites.
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
Waist circumference is measured in centimeters (cm) according to standardized clinical procedures across study sites.
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
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).
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
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.
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
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).
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
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)
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
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
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
Health-related quality of life is evaluated using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument consists of two parts: 1. 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. 2. 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.
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
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.
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
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.
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
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).
Time frame: At Month 6 = 6 months (+/- 15 days)
The resort to a co-intervention
The number and type of each co-intervention (medical, paramedical)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Month 6 (±15 days)
Number of device-related adverse events
Safety is evaluated by tracking the total number and nature of non-serious adverse events related to the use of the AXOMOVE THERAPY medical device recorded during the 6-month follow-up period.
Time frame: Between Month 0 and Month 6 (±15 days)
Number of device-related serious adverse events
Safety is evaluated by tracking the total number and nature of Serious Adverse Events (SAEs) related to the use of the AXOMOVE THERAPY medical device recorded during the 6-month follow-up period.
Time frame: Between Month 0 and Month 6 (±15 days)
Number of device defects
Safety and technical reliability are evaluated by tracking the total number and nature of device defects or malfunctions associated with the AXOMOVE THERAPY digital platform recorded during the 6-month follow-up period.
Time frame: Between Month 0 and Month 6 (±15 days)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 18 months later.
Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 18 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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