Effect of Bone on Vibration-Induced Muscle Strength Gain

NCT01310348 | Completed

• 1 other identifier: BEAH FTR-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Mass; Effects of Vibration

Keywords

Bone; Muscle strength; whole-body vibration

Outcome Measures

Primary Outcomes (1)

• Vibration-induced muscle strength gain

  Effects of bone mineral density on vibration-induced muscle strength gain

  6 months

Study Arms (2)

Very low magnitude vibration

PLACEBO COMPARATOR

Very low magnitude vibration

Device: WBV (Sham stimulation)

Training

EXPERIMENTAL

The whole-body vibration (WBV) training

Device: whole-body vibration (WBV)

Interventions

whole-body vibration (WBV) DEVICE

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.

Also known as: Cyclic mechanical loading

Training

WBV (Sham stimulation) DEVICE

Sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.

Very low magnitude vibration

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women,
• Women with ages varying between 20 and 40 years
• Right-handed women

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.

  PMID: 25207162 DERIVED

Study Officials

• ILHAN KARACAN, MD

  Bagcilar Training & Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Physical Med & Rehab Clinic

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

TU (1)