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

NCT ID: NCT01982214

Last Updated: 2015-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

sedentary

No intervention

Group Type: SHAM_COMPARATOR

sedentary

Intervention Type: DEVICE

No intervention

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.

Group Type: EXPERIMENTAL

Vibration

Intervention Type: 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

Interventions

sedentary

No intervention

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

Power Plate Limited, London, UK

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry THOMAS, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2009-A00896-51

Identifier Type: OTHER

Identifier Source: secondary_id

0908095

Identifier Type: -

Identifier Source: org_study_id