Chronic DiseaseCOCORAPANCT06119594
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
A study testing Body Comp Pro connected scale (Withings manufacturer) in people with Chronic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Body Comp Pro connected scale (Withings manufacturer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu
Paris, 75181 Paris Cedex 04
About this study
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.
Read more
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
- Conditions
- Chronic Disease
- Being tested
- Body Comp Pro connected scale (Withings manufacturer)
- Keywords
- physical activity rehabilitation program, Connected scale
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Standard follow-up group | No intervention | Routine care |
| Connected scale group | Experimental | Routine care + use of connected scale during 6 months Receives: Device: Body Comp Pro connected scale (Withings manufacturer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months from initiation of physical activity rehabilitation program
Secondary outcomes (8)
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)
Measured: 6 weeks from initiation of physical activity rehabilitation program
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)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of 6 minute walk test (6MWT) at 6 months for each patient
6 minute walk test (Higher mean better outcome)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of 30 sec sit-to-stand test at 6 months for each patient
30 sec sit-to-stand test (Higher mean better outcome)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of Ito-Shirado test at 6 months for each patient
Ito-Shirado test (Higher mean better outcome)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of Sorensen test at 6 months for each patient
Sorensen test (Higher mean better outcome)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of Handgrip test at 6 months for each patient
Handgrip test (Higher mean better outcome)
Measured: 6 months from initiation of physical activity rehabilitation program
Measurement of VO2max at 6 months for each patient
VO2
Measured: 6 months from initiation of physical activity rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start27 Aug 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, Withings
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119594
- Sponsor's protocol ID
- APHP230549
- Other IDs
- 2023-A01156-39
- Acronym
- COCORAPA
- Status last verified
- Sep 2025
- First submitted
- 16 Oct 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06119594
- Acronym / sponsor ID
- COCORAPA / APHP230549
- Conditions
- Chronic Disease
- Keywords
- physical activity rehabilitation program, Connected scale
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, Withings
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Standard follow-up group | No intervention | –Routine care |
| Connected scale group | Experimental | Device: Body Comp Pro connected scale (Withings manufacturer)Routine care + use of connected scale during 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Connected scale group |
Primary outcome
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)
8 secondary outcomes
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
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
Measurement of 6 minute walk test (6MWT) at 6 months for each patient
Time frame: 6 months from initiation of physical activity rehabilitation program
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
Measurement of Ito-Shirado test at 6 months for each patient
Time frame: 6 months from initiation of physical activity rehabilitation program
Measurement of Sorensen test at 6 months for each patient
Time frame: 6 months from initiation of physical activity rehabilitation program
Measurement of Handgrip test at 6 months for each patient
Time frame: 6 months from initiation of physical activity rehabilitation program
Measurement of VO2max at 6 months for each patient
Time frame: 6 months from initiation of physical activity rehabilitation program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Comp Pro connected scale (Withings manufacturer) in people with Chronic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.