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Completed

NCT Number: NCT03910348

Effects of Whole-Body Vibration and High Impact Exercises in Postmenopausal Women

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

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole-body vibration exercise

Device

The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA).

High-impact exercise

Other

In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session

Primary outcomes

  1. 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

  1. Change from Baseline Bone Formation Marker at 3-months and 6-months

    Time frame: baseline, 3-month, 6-month

    The serum osteocalcin (OC) level

  2. Change from Baseline Bone Resorption Marker- at 3-months and 6-months

    Time frame: baseline, 3-month, 6-month

    The serum C-terminal telopeptide of type I collagen (CTx) levels

  3. Change from Baseline Fall risk at 3-months and 6-months

    Time frame: baseline, 3-month, 6-month

    A computerized static posturography device was used to measure the fall index

  4. Change from Baseline Functional Balance at 3-months and 6-months

    Time frame: baseline, 3-month, 6-month

    Timed Up and Go (TUG) test

  5. Change from Baseline Health-related Quality of Life at 6 months

    Time frame: baseline, 6-month

    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)

  6. Change from Baseline Depressive Symptoms at 6 months

    Time frame: baseline, 3-month, 6-month

    Beck Depression Inventory

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2019
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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