Clinical trial NCT06119594: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: physical activity rehabilitation program
Connected scale
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Hôpital Lariboisière Fernand Widal
name: Hotel Dieu Hospital
name: Withings
First posted: 2023-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient.
timeFrame: 6 months from initiation of physical activity rehabilitation program
Secondary outcomes:
measure: Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient.
timeFrame: 6 weeks from initiation of physical activity rehabilitation program
measure: Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of 6 minute walk test (6MWT) at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of 30 sec sit-to-stand test at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of Ito-Shirado test at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of Sorensen test at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of Handgrip test at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
measure: Measurement of VO2max at 6 months for each patient
timeFrame: 6 months from initiation of physical activity rehabilitation program
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d&#39;Investigations en Médecine du Sport - Hôpital Hôtel Dieu
Study officials:
References: