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NCT Number: NCT06119594

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu

Paris, 75181 Paris Cedex 04, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

    Time frame: 6 months from initiation of physical activity rehabilitation program

    Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)

Secondary outcomes

  1. Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months from initiation of physical activity rehabilitation program

    VO2

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Hotel Dieu Hospital
  • Hôpital Lariboisière Fernand Widal
  • Withings

Registry information

Acronym: COCORAPA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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