Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT06119594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2023-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-10-16', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient.', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)'}], 'secondaryOutcomes': [{'measure': 'Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient.', 'timeFrame': '6 weeks from initiation of physical activity rehabilitation program', 'description': 'Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)'}, {'measure': 'Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'Ricci \\& Gagnon questionnaire (9 - 45 ; Higher mean better outcome)'}, {'measure': 'Measurement of 6 minute walk test (6MWT) at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': '6 minute walk test (Higher mean better outcome)'}, {'measure': 'Measurement of 30 sec sit-to-stand test at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': '30 sec sit-to-stand test (Higher mean better outcome)'}, {'measure': 'Measurement of Ito-Shirado test at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'Ito-Shirado test (Higher mean better outcome)'}, {'measure': 'Measurement of Sorensen test at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'Sorensen test (Higher mean better outcome)'}, {'measure': 'Measurement of Handgrip test at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'Handgrip test (Higher mean better outcome)'}, {'measure': 'Measurement of VO2max at 6 months for each patient', 'timeFrame': '6 months from initiation of physical activity rehabilitation program', 'description': 'VO2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity rehabilitation program', 'Connected scale'], 'conditions': ['Chronic Disease']}, 'descriptionModule': {'briefSummary': '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 :\n\n* Control group (N = 45) : routine care\n* Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks.\n\nPatients will be see again at 6 months, and the following parameters will be comparer between the two groups :\n\n* SF-36 questionnaire\n* Ricci \\& Gagnon questionnaire\n* 6MWT\n* 30 sec sit-to stand test\n* Ito-Shirado test\n* Sorensen test\n* Handgrip test\n* MaxV02'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (male or female) aged 18 and over\n* Patient able to express free, informed and written consent\n* Patient participating in the physical activity rehabilitation program at the CIMS of the Hôtel Dieu\n* Patient suffering from a known, stable and diagnosed chronic disease\n* Patient autonomous in taking treatments for their ALD\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient under legal protection (guardianship, curatorship)\n* Patient deprived of liberty by a judicial or administrative decision\n* 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\n* Patient with suspected cardiac pathology during the HDJ for admission to the program\n* Patient with episode of decompensation or exacerbation\n* Patient with a pacemaker or implantable automatic defibrillator\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06119594', 'acronym': 'COCORAPA', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'APHP230549'}, 'secondaryIdInfos': [{'id': '2023-A01156-39', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard follow-up group', 'description': 'Routine care'}, {'type': 'EXPERIMENTAL', 'label': 'Connected scale group', 'description': 'Routine care + use of connected scale during 6 months', 'interventionNames': ['Device: Body Comp Pro connected scale (Withings manufacturer)']}], 'interventions': [{'name': 'Body Comp Pro connected scale (Withings manufacturer)', 'type': 'DEVICE', 'description': '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)', 'armGroupLabels': ['Connected scale group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75181 Paris Cedex 04', 'city': 'Paris', 'country': 'France', 'facility': 'Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital Lariboisière Fernand Widal', 'class': 'OTHER'}, {'name': 'Hotel Dieu Hospital', 'class': 'OTHER'}, {'name': 'Withings', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}