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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Osteopenia

Treatments: Device: sedentary; Device: Vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT01982214

0908095

2009-A00896-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

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,
• severe migraine,
• pacemaker,
• every neurodegenerative or neuromuscular disease,
• dementia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

sedentary

Sham Comparator group

Description:

No intervention

Treatment:

Device: sedentary

Vibration

Experimental group

Description:

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.

Treatment:

Device: Vibration