Effect of Bone on Vibration-Induced Muscle Electrical Activity

NCT01367041 | Completed DMC

• 1 other identifier: BEAH FTR-3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

bone; muscle electrical activity; whole-body vibration

Outcome Measures

Primary Outcomes (1)

• Vibration-induced muscle electrical activity

  3 months

Study Arms (2)

Bone loss

EXPERIMENTAL

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

Procedure: vibration

Normal

EXPERIMENTAL

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

Procedure: vibration

Interventions

vibration PROCEDURE

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

Bone loss; Normal

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead
• Istanbul University: collaborator

Study Sites (1)

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Vibration

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• ILHAN KARACAN, MD

  Bagcilar Training & Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: 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: April 6, 2011
• First Posted: June 6, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

TU (1)