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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00896-51 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire | UNKNOWN |
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A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged 55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the non weight bearing radius.
The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone markers will be analyzed longitudinally. The secondary aim is to assess muscle performance and proprioception. Finally will be assessed markers of cartilage degradation and synthesis, no study has been published on this tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sedentary | Sham Comparator | No intervention |
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| Vibration | Experimental | Subjects in this group will be submitted to the WBV for 5 to 20 minutes, 2 or 3 times a week while 12 months. The training included light squats at 35-50 Hz and ended up by stretching and relaxation exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sedentary | Device | No intervention |
| |
| Vibration |
| Measure | Description | Time Frame |
|---|---|---|
| Trabecular bone volume at the femoral neck | bone densitometric parameters will be evaluated with DXA (dual x-ray absorptiometry) | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Serum bone markers | We will evaluated the activity of bone serum markers of bone formation (amino-terminal propeptide type I procollagen, PINP) and of bone resorption (C telopeptide of type I collagen, S-CTX). | 12 month |
| Bone cortical compartment at radius and tibia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry THOMAS, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42000 | France |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Device |
Subjects will be submitted to the WBV for 5 to 20 minutes, 2 or 3 times a week with frequencies between 35 to 50 Hz while 12 months |
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| 12 month |