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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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06119594
Acronym
COCORAPA
Enrollment
90
Registered
2023-11-07
Start date
2024-08-27
Completion date
2026-06-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

physical activity rehabilitation program, Connected scale

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

Interventions

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)

Sponsors

Hôpital Lariboisière Fernand Widal
CollaboratorOTHER
Hotel Dieu Hospital
CollaboratorOTHER
Withings
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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 programShort Form 36 questionnaire (0 - 100 ; Higher mean better outcome)

Secondary

MeasureTime frameDescription
Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient6 months from initiation of physical activity rehabilitation programRicci & Gagnon questionnaire (9 - 45 ; Higher mean better outcome)
Measurement of 6 minute walk test (6MWT) at 6 months for each patient6 months from initiation of physical activity rehabilitation program6 minute walk test (Higher mean better outcome)
Measurement of 30 sec sit-to-stand test at 6 months for each patient6 months from initiation of physical activity rehabilitation program30 sec sit-to-stand 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 programShort Form 36 questionnaire (0 - 100 ; Higher mean better outcome)
Measurement of Sorensen test at 6 months for each patient6 months from initiation of physical activity rehabilitation programSorensen test (Higher mean better outcome)
Measurement of Handgrip test at 6 months for each patient6 months from initiation of physical activity rehabilitation programHandgrip test (Higher mean better outcome)
Measurement of VO2max at 6 months for each patient6 months from initiation of physical activity rehabilitation programVO2
Measurement of Ito-Shirado test at 6 months for each patient6 months from initiation of physical activity rehabilitation programIto-Shirado test (Higher mean better outcome)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026