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

Not Applicable

Not yet recruiting

• Conditions: Chronic Disease

• 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

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Start: 2024-09-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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)
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)

Trial Locations

Locations (1)

Centre d&#39;Investigations en Médecine du Sport - Hôpital Hôtel Dieu; 🇫🇷 Paris, France