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

Chronic Disease Clinical Trial

— COCORAPA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119594
• Other study ID #: APHP230549
• Secondary ID: 2023-A01156-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Pierre FERRAND, Mr
• Phone: 0142348985
• Email: pierre.ferrand[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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)

Locations

Country	Name	City	State
France	Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, Withings

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Measurement of VO2max at 6 months for each patient	VO2	6 months from initiation of physical activity rehabilitation program