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

Osteopenia Clinical Trial

— VIBROS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982214
• Other study ID #: 0908095
• Secondary ID: 2009-A00896-51
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: August 7, 2015
• Start date: April 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

Device:
• sedentary
No intervention
• Vibration
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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trabecular bone volume at the femoral neck	bone densitometric parameters will be evaluated with DXA (dual x-ray absorptiometry)	12 month	No
Secondary	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	No
Secondary	Bone cortical compartment at radius and tibia		12 month	No