Skip to main content
Clinical Trials/NCT03910348
NCT03910348
Completed
Not Applicable

Effects of Whole-Body Vibration and High Impact Exercises on the Bone Metabolism and Fall Risk in Postmenopausal Women

Istanbul University0 sites58 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis, Postmenopausal
Sponsor
Istanbul University
Enrollment
58
Primary Endpoint
Change from Baseline Bone Mineral Density at 6 months
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

We investigated the effects of whole body vibration (WBV) and high-impact (HI) exercises in postmenopausal women with low bone mineral density. In summary, WBV exercises are effective in preventing bone loss and WBV and HI exercise programs are effective in decreasing fall risk, increasing health-related quality of life and improving depressive symptoms

Detailed Description

Purpose: The aim of this study was to determine the effects of six months of supervised whole-body vibration (WBV) and high-impact (HI) exercises on bone mineral density (BMD), serum bone turnover markers, fall risk, health-related quality of life (HRQoL) and depressive symptoms in postmenopausal women, additionally, to evaluate the advantage of each training program to another. Methods: In a prospective, randomized controlled 6-month interventional trial 58 eligible postmenopausal women were assigned to WBV training group (n=19), HI training group (n=19), or control group (n=20). The patients in both training groups participated in a supervised training program, which consisted of the one-hour exercise session three times a week for six months. The WBV groups received vibration (30-35 Hz, 2-4 mm) in five different static positions. The HI group jumped rope (10-50 jumps/day). All patients received calcium (1000 mg) and vitamin D (880 IU) supplementation per day. In all participants, baseline and six-month BMD at the lumbar spine and femur were measured by Dual-energy X-ray Absorptiometry (DXA). Serum osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTx) were measured at baseline, three- and six-month intervals. Fall risk was assessed by using the Timed Up and Go (TUG) test and fall index measured by static posturography at baseline, three- and six-month intervals. HRQoL and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Beck Depression Inventory (BDI), respectively, at baseline and six-month of the study.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
September 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ekin Ilke Sen

Medical doctor

Istanbul University

Eligibility Criteria

Inclusion Criteria

  • Postmenopausal women aged 40-65 years old
  • Bone mineral density T-scores between -2.0 and -3.0 at the L1-L4, L2-L4, femoral neck, trochanter and/or total hip regions
  • Serum 25(OH)vitamin D level ≥ 30 ng/ml.

Exclusion Criteria

  • The use of any medications and/or disease that affect bone metabolism
  • Neuromuscular performance, and/or balance; presence of cardiovascular, pulmonary, neuromuscular, and/or chronic diseases that affect exercise training
  • Presence of an osteoporotic fracture
  • Presence of a musculoskeletal disease, such as an acute lumbar herniated disc and/or spondylolisthesis
  • Presence of gall or kidney stones, prostheses, intraocular lenses, and/or implants
  • Body mass index ≥35 kg/m²
  • Thrombosis history

Outcomes

Primary Outcomes

Change from Baseline Bone Mineral Density at 6 months

Time Frame: baseline and 6 month

The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry

Secondary Outcomes

  • Change from Baseline Functional Balance at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Bone Resorption Marker- at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Fall risk at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Health-related Quality of Life at 6 months(baseline, 6-month)
  • Change from Baseline Bone Formation Marker at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Depressive Symptoms at 6 months(baseline, 3-month, 6-month)

Similar Trials