Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women (VIBROS)
Primary Purpose
Osteopenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sedentary
Vibration
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia focused on measuring osteopenia, whole body vibration, women, bone microarchitecture, bone density
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
Sites / Locations
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
sedentary
Vibration
Arm Description
No intervention
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.
Outcomes
Primary Outcome Measures
Trabecular bone volume at the femoral neck
bone densitometric parameters will be evaluated with DXA (dual x-ray absorptiometry)
Secondary Outcome Measures
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).
Bone cortical compartment at radius and tibia
Full Information
NCT ID
NCT01982214
First Posted
November 6, 2013
Last Updated
August 7, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire
1. Study Identification
Unique Protocol Identification Number
NCT01982214
Brief Title
Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women
Acronym
VIBROS
Official Title
Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
osteopenia, whole body vibration, women, bone microarchitecture, bone density
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sedentary
Arm Type
Sham Comparator
Arm Description
No intervention
Arm Title
Vibration
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
sedentary
Intervention Description
No intervention
Intervention Type
Device
Intervention Name(s)
Vibration
Other Intervention Name(s)
Power Plate Limited, London, UK
Intervention Description
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
Primary Outcome Measure Information:
Title
Trabecular bone volume at the femoral neck
Description
bone densitometric parameters will be evaluated with DXA (dual x-ray absorptiometry)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Serum bone markers
Description
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
Title
Bone cortical compartment at radius and tibia
Time Frame
12 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry THOMAS, MD PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
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Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women
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