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CompletedNCT01982214VIBROSUpdated Aug 10, 2015

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

An interventional study of sedentary and Vibration in Osteopenia, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to female participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-10.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteopenia

Keywords

  • osteopenia
  • whole body vibration
  • women
  • bone microarchitecture
  • bone density
03

In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's enrollment of 225 is above the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (actual)

Study arms

  • Sham comparator
    sedentary

    No intervention

    Device: sedentary

  • 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

Interventions

  • Devicesedentary

    No intervention

  • DeviceVibration

    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

06

What researchers measure

Primary outcomes

  1. Trabecular bone volume at the femoral neck

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

    Time frame: 12 month

Secondary outcomes

  1. 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).

    Time frame: 12 month

  2. Bone cortical compartment at radius and tibia

    Time frame: 12 month

07

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-etienne, 42000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01982214
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire
Responsible party
Sponsor
First posted
Nov 13, 2013
Start date
Apr 2010
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Aug 10, 2015

Study contacts

Thierry THOMAS, MD PhD
principal investigator · CHU de Saint-Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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