Trial · NCT07903025
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Body weight | 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) | Weight is measured in kilograms (kg) using standard calibrated clinical scales across study sites. |
| Secondary | Waist circumference | 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 is measured in centimeters (cm) according to standardized clinical procedures across study sites. |
| Secondary | Body composition | 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 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). |
| Secondary | Level of physical activity | 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) | 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. |
| Secondary | Pain | 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 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). |
| Secondary | Kinesiophobia | 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 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) |
| Secondary | Health-Related Quality of Life in the context of obesity | 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) | 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 |
| Secondary | Health-related quality of life | 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 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. |
| Secondary | Anxiety and depression | 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 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. |
| Secondary | Patient confidence | 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 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. |
| Secondary | Patient adherence to prescribed exercise program | At Month 6 = 6 months (+/- 15 days) | 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). |
| Secondary | The resort to a co-intervention | Between Month 0 and Month 6 (±15 days) | The number and type of each co-intervention (medical, paramedical) |
| Secondary | Number and duration of work absences | Between Month 0 and Month 6 (±15 days) | 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. |
| Secondary | Number of unscheduled medical consultations | Between Month 0 and Month 6 (±15 days) | 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. |
| Secondary | Number of unscheduled hospitalizations | Between Month 0 and Month 6 (±15 days) | 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. |
| Secondary | Number of Adapted Physical Activity (APA) and physical therapy sessions | Between Month 0 and Month 6 (±15 days) | 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. |
| Secondary | Overall cost of healthcare utilization per participant | Between Month 0 and Month 6 (±15 days) | 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. |
| Secondary | Patient Out-of-Pocket Expenses | Between Baseline (Month 0) and Month 6 (±15 days) | 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. |
| Secondary | Incremental cost difference between study Arms | At Month 6 (±15 days) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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