Effect of Bone on Vibration-Induced Muscle Electrical Activity

NCT ID: NCT01367041

Last Updated: 2013-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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The aim of this study is to investigate effects of femur exposed to vibration on the rest muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis.

Among patients who will be admitted to the investigators clinic for out-patients and whose bone densitometric measurement will be made with a prediagnosis postmenopausal osteoporosis, a total of 80 voluntaries \[40 having postmenopausal osteoporosis (femur neck or total hip T score \< -2.0) and 40 Controls (Hip and lumbar bone mineral density normal)\] are planned to include in this study.

After the left hip bone mineral density (BMD) and BMC is measured in all cases, whole body vibration will be applied in PMO groups and Controls. The rest muscle electrical activity of left hip muscles will be evaluated at pre-treatment, post-treatment and, during treatment in patients with PMO and then their data will be compared with Controls data.

Plasma sclerostin level will be measured before and 10th minute after vibration.

Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and amplitude of 2 mm for 30 + 30 seconds. WBV will be applied one session only. The left hip BMD and BMC will be evaluated by bone densitometer (Norland).

The rest muscle electrical activity of hip adductor muscles at rest will be measured by PowerLab (data acquisition system, ADInstruments, Australia) device.

This project is planed to be completed in 3 months.

Detailed Description

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It is usually reported that there is a parallelism between changes in the bone structure and function and the muscle structure and function. Sarcopenia is frequently observed in osteoporotic patients. Bone formation increases or bone resorption decreases with exercise.

One of the most important functions of bone bear mechanical loads include body weight. Bone must be strong enough to resist the mechanical loading. Mechanisms need to protect bone when bone is subject to excessive mechanical loading. These mechanisms may mainly focus on strengthening the bone and/or changing vectorial properties of mechanical loading applied bone.

The vectorial properties of mechanical loading applied bone may be controlled by muscle contractions. Bone contains wide mechanoreceptor net constructed by osteocytes. So,distribution of the mechanical loading on bone cross-sectional area is possible to perceive. It may be also possible that inappropriate distribution of mechanical loading on bone crosssectional area is optimized by muscle contractions. To get this regulation, there should be a mechanism that muscle activity is controlled by central nervous system based on mechanical loading distribution on bone cross-sectional area. The investigators previously showed that bone can regulate muscle activity, based on its bone mineral density. According to this study result, it can be suggested there may exist a mechanism that bone sensing mechanical stimuli can send the signals to central nervous system and neuronally regulate muscle activity (bone myo-regulation reflex). (It is also well known that load-induced adaptive bone formation is neuronally regulated. Taken together, a general mechanism, bone reflex, may be defined that bone subjected to loading can neuronally regulate bone formation and muscle activity) 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. It has been showed that bone has an effect on the increase in muscle EMG activity caused by vibration in healthy young adults in a study. In this study, it was reported that vibrations-induced increases in muscle electrical activity of flexor carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR H-reflex was suppressed or depressed during vibration. This findings were reported to support the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate muscle activity.

The aim of this study is to investigate effects of femur exposed to vibration on the rest muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bone loss

Postmenopausal women with osteoporosis, whole body vibration will be applied at 40 Hz, 2mm amplitude, 30+30s

Group Type EXPERIMENTAL

vibration

Intervention Type PROCEDURE

Vibration frequency: 40 Hz, duration: 30+30 s, 2mm amplitude

Normal

Postmenopausal women without osteoporosis, whole body vibration will be applied at 40 Hz, 2mm amplitude, 30+30s

Group Type EXPERIMENTAL

vibration

Intervention Type PROCEDURE

Vibration frequency: 40 Hz, duration: 30+30 s, 2mm amplitude

Interventions

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vibration

Vibration frequency: 40 Hz, duration: 30+30 s, 2mm amplitude

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* postmenopausal women with osteoporosis(femur neck or total hip T score\<-2) or postmenopausal women without osteoporosis (normal femur and lumbar bone mineral density)
* women with ages varying between 45 and 65 years
* right handed women

Exclusion Criteria

* secondary osteoporosis, fracture history
* early menopause
* osteopenia (-2 \< femur neck or total hip T score \< 1)
* neuropathy (central or peripheral)
* muscle, tendon, joint, vascular, dermatologic disease in lower extremity
* postural abnormality (scoliosis, kyphosis,short leg etc)
* systemic diseases (severe hypertension, coronary heart disease, etc)
* endocrine-metabolic bone diseases\[paget, osteomalacia\]
* medication that could affect the musculoskeletal system
* obesity (BMI \>30 kg/m2 or body weight\>80kg)
* professional sportswoman
* female doing regular sports activities
* non-cooperative subject
* vertigo
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role collaborator

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Karacan

Chief of Physical Med & Rehab Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ILHAN KARACAN, MD

Role: STUDY_CHAIR

Bagcilar Training & Research Hospital

Locations

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Bagcilar Training & Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BEAH FTR-3

Identifier Type: -

Identifier Source: org_study_id

NCT00961545

Identifier Type: -

Identifier Source: nct_alias

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