Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a Reconditioning Program Through Physical Activity Adapted for Patients Suffering From Chronic Diseases
- Conditions
- Chronic Disease
- Interventions
- Device: Body Comp Pro connected scale (Withings manufacturer)
- Registration Number
- NCT06119594
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The goal of this interventional study is to evaluate the impact of the use of a connected impedance scale on the physical and mental quality of life of patients suffering from chronic diseases and participating in a physical activity rehabilitation program. The main objective is to know if a regular monitoring of the evolution of body composition parameters recorded by the connected scale would allow patients participating in the Physical Activity rehabilitation program at Hôtel-Dieu to follow in real time the effects of such program, not on weight itself but on body composition, and that this would contribute to a better perception of physical and mental quality of life at the end of the program 90 Participants will be randomized in two groups :
* Control group (N = 45) : routine care
* Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks.
Patients will be see again at 6 months, and the following parameters will be comparer between the two groups :
* SF-36 questionnaire
* Ricci \& Gagnon questionnaire
* 6MWT
* 30 sec sit-to stand test
* Ito-Shirado test
* Sorensen test
* Handgrip test
* MaxV02
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Patient (male or female) aged 18 and over
- Patient able to express free, informed and written consent
- Patient participating in the physical activity rehabilitation program at the CIMS of the Hôtel Dieu
- Patient suffering from a known, stable and diagnosed chronic disease
- Patient autonomous in taking treatments for their ALD
- Patient affiliated to a social security system
- Patient under legal protection (guardianship, curatorship)
- Patient deprived of liberty by a judicial or administrative decision
- Patient with functional limitations that do not allow a physical assessment or result in a walking distance < 350 m during the HDJ for admission to the program
- Patient with suspected cardiac pathology during the HDJ for admission to the program
- Patient with episode of decompensation or exacerbation
- Patient with a pacemaker or implantable automatic defibrillator
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Connected scale group Body Comp Pro connected scale (Withings manufacturer) Routine care + use of connected scale during 6 months
- Primary Outcome Measures
Name Time Method Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient. 6 months from initiation of physical activity rehabilitation program Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)
- Secondary Outcome Measures
Name Time Method Measurement of Sorensen test at 6 months for each patient 6 months from initiation of physical activity rehabilitation program Sorensen test (Higher mean better outcome)
Measurement of Handgrip test at 6 months for each patient 6 months from initiation of physical activity rehabilitation program Handgrip test (Higher mean better outcome)
Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient. 6 weeks from initiation of physical activity rehabilitation program Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)
Measurement of 30 sec sit-to-stand test at 6 months for each patient 6 months from initiation of physical activity rehabilitation program 30 sec sit-to-stand test (Higher mean better outcome)
Measurement of Ito-Shirado test at 6 months for each patient 6 months from initiation of physical activity rehabilitation program Ito-Shirado test (Higher mean better outcome)
Measurement of VO2max at 6 months for each patient 6 months from initiation of physical activity rehabilitation program VO2
Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient 6 months from initiation of physical activity rehabilitation program Ricci \& Gagnon questionnaire (9 - 45 ; Higher mean better outcome)
Measurement of 6 minute walk test (6MWT) at 6 months for each patient 6 months from initiation of physical activity rehabilitation program 6 minute walk test (Higher mean better outcome)
Trial Locations
- Locations (1)
Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu
🇫🇷Paris, France