Effect of Bone on Vibration-Induced Muscle Strength Gain (EBVIMSG)
| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2011 | ||||
| Last Updated Date | August 12, 2012 | ||||
| Start Date ICMJE | April 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Vibration-induced muscle strength gain [ Time Frame: 6 months ] [ Designated as safety issue: No ] Effects of bone mineral density on vibration-induced muscle strength gain |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01310348 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Bone on Vibration-Induced Muscle Strength Gain | ||||
| Official Title ICMJE | Effect of Bone Mineral Density on Vibration-Induced Muscle Strength Gain at The Lower Limbs | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Turkey | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01310348 | ||||
| Other Study ID Numbers ICMJE | BEAH FTR-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Karacan, Bagcilar Training and Research Hospital | ||||
| Study Sponsor ICMJE | Bagcilar Training and Research Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bagcilar Training and Research Hospital | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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