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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01156-39 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| Hôpital Lariboisière Fernand Widal | OTHER |
| Hotel Dieu Hospital | OTHER |
| Withings | INDUSTRY |
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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 :
Patients will be see again at 6 months, and the following parameters will be comparer between the two groups :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard follow-up group | No Intervention | Routine care | |
| Connected scale group | Experimental | Routine care + use of connected scale during 6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigations en Médecine du Sport - Hôpital Hôtel Dieu | Paris | 75181 Paris Cedex 04 | France |
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Comparative, controlled, randomized by cluster 1:1 open, in two parallel arms
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Ricci & Gagnon questionnaire (9 - 45 ; Higher mean better outcome) |
| 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) | 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) | 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) | 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) | 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) | 6 months from initiation of physical activity rehabilitation program |
| Measurement of VO2max at 6 months for each patient | VO2 | 6 months from initiation of physical activity rehabilitation program |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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