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

NCT06119594 | Active Not Recruiting

• 2 other identifiers: APHP2305492023-A01156-39
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Disease

Keywords

physical activity rehabilitation program; Connected scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Measurement of 6 minute walk test (6MWT) at 6 months for each patient

  6 months from initiation of physical activity rehabilitation program

• Measurement of 30 sec sit-to-stand test at 6 months for each patient

  6 months from initiation of physical activity rehabilitation program

• Measurement of Ito-Shirado test at 6 months for each patient

  6 months from initiation of physical activity rehabilitation program

Study Arms (2)

Standard follow-up group

NO INTERVENTION

Routine care

Connected scale group

EXPERIMENTAL

Routine care + use of connected scale during 6 months

Device: Body Comp Pro connected scale (Withings manufacturer)

Interventions

Body Comp Pro connected scale (Withings manufacturer) DEVICE

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)

Connected scale group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Hôpital Lariboisière Fernand Widal: collaborator
• Hotel Dieu Hospital: collaborator
• Withings: collaborator

Study Sites (1)

Centre d&#39;Investigations en Médecine du Sport - Hôpital Hôtel Dieu

Paris, 75181 Paris Cedex 04, France

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 7, 2023
• Study Start: August 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)