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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Device: sedentary; Device: Vibration

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sedentary; No intervention	Device: sedentary; No intervention
Experimental: Vibration; 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.	Device: 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; Other Names: Power Plate Limited, London, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		12 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire
• Investigators: Principal Investigator: Thierry THOMAS, MD PhD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: bone density; women; bone microarchitecture; osteopenia; whole body vibration
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 0908095; 2009-A00896-51 (Other Identifier: ANSM)