COCORAPA: 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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06119594
Collaborator
Hôpital Lariboisière Fernand Widal (Other), Hotel Dieu Hospital (Other), Withings (Industry)
90
1
2
12
7.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Body Comp Pro connected scale (Withings manufacturer)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Comparative, controlled, randomized by cluster 1:1 open, in two parallel armsComparative, controlled, randomized by cluster 1:1 open, in two parallel arms
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. Measurement of VO2max at 6 months for each patient [6 months from initiation of physical activity rehabilitation program]

    VO2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu Paris France 75181 Paris Cedex 04

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT06119594
Other Study ID Numbers:
  • APHP230549
  • 2023-A01156-39
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023