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

NCT01982214 | Completed

• 2 other identifiers: 09080952009-A00896-51
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

osteopenia; whole body vibration; women; bone microarchitecture; bone density

Outcome Measures

Primary Outcomes (1)

• Trabecular bone volume at the femoral neck

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

  12 month

Secondary Outcomes (2)

• Serum bone markers

  12 month

• Bone cortical compartment at radius and tibia

  12 month

Study Arms (2)

sedentary

SHAM COMPARATOR

No intervention

Device: sedentary

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.

Device: Vibration

Interventions

sedentary DEVICE

No intervention

sedentary

Vibration 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

Also known as: Power Plate Limited, London, UK

Vibration

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire: collaborator

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thierry THOMAS, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: April 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

FR (1)