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Effect of Bone on Vibration-Induced Muscle Electrical Activity (PMO-WBV-sEMG)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vibration
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring bone, muscle electrical activity, whole-body vibration

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bagcilar Training & Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bone loss

Normal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Vibration-induced muscle electrical activity

Secondary Outcome Measures

Full Information

First Posted
April 6, 2011
Last Updated
January 29, 2013
Sponsor
Bagcilar Training and Research Hospital
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT01367041
Brief Title
Effect of Bone on Vibration-Induced Muscle Electrical Activity
Acronym
PMO-WBV-sEMG
Official Title
Effect of Hip Bone Mineral Density / Content on Vibration-Induced Hip Adductors Muscle Electrical Activity in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bagcilar Training and Research Hospital
Collaborators
Istanbul University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
bone, muscle electrical activity, whole-body vibration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone loss
Arm Type
Experimental
Arm Description
Postmenopausal women with osteoporosis, whole body vibration will be applied at 40 Hz, 2mm amplitude, 30+30s
Arm Title
Normal
Arm Type
Experimental
Arm Description
Postmenopausal women without osteoporosis, whole body vibration will be applied at 40 Hz, 2mm amplitude, 30+30s
Intervention Type
Procedure
Intervention Name(s)
vibration
Intervention Description
Vibration frequency: 40 Hz, duration: 30+30 s, 2mm amplitude
Primary Outcome Measure Information:
Title
Vibration-induced muscle electrical activity
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILHAN KARACAN, MD
Organizational Affiliation
Bagcilar Training & Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bagcilar Training & Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effect of Bone on Vibration-Induced Muscle Electrical Activity

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