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

Study Overview
=================
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

Official Title
-----------------
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

Intervention / Treatment
-----------------
* Device: Body Comp Pro connected scale (Withings manufacturer)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard follow-up group<br>Routine care | |
| Experimental: Connected scale group<br>Routine care + use of connected scale during 6 months | Device: Body Comp Pro connected scale (Withings manufacturer)<br>* Patients in the intervention group will use the connected scale at a minimum frequency of once a week from receipt of the scale and throughout their participation in the research (6 months)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient. | Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient. | Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome) | 6 weeks from initiation of physical activity rehabilitation program | 
| Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient | Ricci & Gagnon questionnaire (9 - 45 ; Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of 6 minute walk test (6MWT) at 6 months for each patient | 6 minute walk test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of 30 sec sit-to-stand test at 6 months for each patient | 30 sec sit-to-stand test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of Ito-Shirado test at 6 months for each patient | Ito-Shirado test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of Sorensen test at 6 months for each patient | Sorensen test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of Handgrip test at 6 months for each patient | Handgrip test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | 
| Measurement of VO2max at 6 months for each patient | VO2 | 6 months from initiation of physical activity rehabilitation program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity rehabilitation program, Connected scale