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 (COCORAPA)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Device: Body Comp Pro connected scale (Withings manufacturer)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75181 Paris Cedex 04
    • Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard follow-up group; Routine care
Experimental: Connected scale group; Routine care + use of connected scale during 6 months	Device: Body Comp Pro connected scale (Withings manufacturer); 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)

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Hotel Dieu Hospital; Withings; Hôpital Lariboisière Fernand Widal

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: physical activity rehabilitation program; Connected scale
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease
• Other Study ID Numbers: APHP230549; 2023-A01156-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No