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Completed

NCT Number: NCT01982214

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sedentary

Device

No intervention

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

Other names: Power Plate Limited, London, UK

Primary outcomes

  1. Trabecular bone volume at the femoral neck

    Time frame: 12 month

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

Secondary outcomes

  1. Serum bone markers

    Time frame: 12 month

    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).

  2. Bone cortical compartment at radius and tibia

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

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

Registry information

Acronym: VIBROS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2013
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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