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Clinical Trials/NCT01982214
NCT01982214
Completed
Not Applicable

Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country225 target enrollmentApril 2010
ConditionsOsteopenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteopenia
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
225
Locations
1
Primary Endpoint
Trabecular bone volume at the femoral neck
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Be sedentary (less than 2 hours physical activity of low intensity per week)
  • Fracture risk Densitometry Risk factors (FRAX) index between 3 and 10%
  • Consent form signed

Exclusion Criteria

  • Bone concomitant disease (such as Paget's disease, osteomalacia),
  • Endocrinopathy defined on biological criteria (such as Cushing's disease, hyperparathyroidism, hyperthyroidism, hypogonadism),
  • Smoking habits (more than 5 cigarettes per day), chronic alcoholism,
  • Treatments received in the previous 6 months affecting bone metabolism such as anabolics, anti-osteoporotic treatment, corticosteroids.
  • Having a prosthesis (femur and knee),or recently placed metal bouts or plates
  • acute thrombotic problems,
  • severe heart- and vascular diseases,
  • recent injuries due to operation or polyclinical intervention,
  • acute hernia, discopathy, spondylolysis,
  • epilepsy,

Outcomes

Primary Outcomes

Trabecular bone volume at the femoral neck

Time Frame: 12 month

bone densitometric parameters will be evaluated with DXA (dual x-ray absorptiometry)

Secondary Outcomes

  • Serum bone markers(12 month)
  • Bone cortical compartment at radius and tibia(12 month)

Study Sites (1)

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