- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310348
Effect of Bone on Vibration-Induced Muscle Strength Gain (EBVIMSG)
Effect of Bone Mineral Density on Vibration-Induced Muscle Strength Gain at The Lower Limbs
The aim of this study is to investigate whether there is a relation between bone mineral density of lower limbs exposed to vibration and the muscle strength gain in the knee extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in the knee extensors and flexors in healthy young adult women.
Forty healthy young adult women are planned to include in this study. The participants meeting the criteria were randomized into two groups: the training group (20 cases) and the Control group (20 cases).
The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV platform. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects will be asked to report negative side effects or adverse reactions in their training diary. In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength will be measured before and after training period. Isokinetic torque will be measured with the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and muscle strength will be measured before training period. The BMD will be evaluated by bone densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human sclerostin ELISA kit.
The rest muscle electrical activity of right and left knee flexor and extensor muscles will be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle electrical activity will be measured by Powerlab (data acquisition system, ADInstruments, Australia) device.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Vibration has a strong osteogenic effect. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Attempts to explain vibration-induced increases in EMG activity were based on the tonic vibration reflex. Tonic vibration reflex activates the muscle spindles, thereby enhancing the excitatory drive reflex of the alpha motoneurons. On the contrary, it was shown that the vibration treatment did not enhance the muscle spindle sensitivity and led to presynaptic inhibition of muscle spindle group Ia afferents. As an alternative to tonic vibration reflex, the recently described bone myoregulation reflex has been suggested to potentially explain the increased muscle strength and electrical activity induced by vibration. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.
The cyclic mechanical loading to the bone stimulates the osteocytes. According to bone myoregulation reflex, the more the osteocytes are stimulated by the cyclic mechanical loading, the increase occurring in the muscle strength and activity may be more. The rate of osteocytes stimulated by vibration may be determined with serum sclerostin level. Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Bagcilar Training & Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy women,
- Women with ages varying between 20 and 40 years
- Right-handed women
Exclusion Criteria:
- Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
- Medication that could affect the musculoskeletal system
- Postural abnormalities (scoliosis, kyphosis, etc)
Systemic diseases
- Hypertension ( Diastolic > 85 mmHg, Systolic>135 mmHg)
- Heart Diseases (coronary heart disease, conduction or rhythmic problems, pacemaker etc.)
- Abdominal disease (Gallstone etc)
- Urinary disease (kidneystone etc)
- Gynecological disease (menstrual irregularities, etc)
- Infectious disease
- Endocrine diseases such as diabetes mellitus or other disease
- Neurologic disorders (central or peripheral)
- Pregnancy or lactation
- Obesity (BMI >30 kg/m2 or body weight > 80 kg )
- Vertigo
- Cognitive dysfunction
- Professional/regular sports activity and heavy worker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
The whole-body vibration (WBV) training
|
The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period.
Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle.
The training volume will be increased systematically over the 4-week training period.
The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration.
Other Names:
|
Placebo Comparator: Very low magnitude vibration
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Sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vibration-induced muscle strength gain
Time Frame: 6 months
|
Effects of bone mineral density on vibration-induced muscle strength gain
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6 months
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Collaborators and Investigators
Investigators
- Study Chair: ILHAN KARACAN, MD, Bagcilar Training & Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEAH FTR-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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