Chronic Disease Clinical Trial
— COCORAPAOfficial 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
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
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Hôpital Lariboisière Fernand Widal, Hotel Dieu Hospital, Withings |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | 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) | 6 weeks from initiation of physical activity rehabilitation program | |
Secondary | 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) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of 6 minute walk test (6MWT) at 6 months for each patient | 6 minute walk test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of 30 sec sit-to-stand test at 6 months for each patient | 30 sec sit-to-stand test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of Ito-Shirado test at 6 months for each patient | Ito-Shirado test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of Sorensen test at 6 months for each patient | Sorensen test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of Handgrip test at 6 months for each patient | Handgrip test (Higher mean better outcome) | 6 months from initiation of physical activity rehabilitation program | |
Secondary | Measurement of VO2max at 6 months for each patient | VO2 | 6 months from initiation of physical activity rehabilitation program |
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