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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal; Exercise Therapy
• Intervention / Treatment: Device: Whole-body vibration exercise; Other: High-impact exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole body vibration exercise; The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting (2-4mm peak to peak) on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Each patient received the vibrations under supervision using five different static positions: squat, deep squat, widestep squat, lunge, and hands-front lunge. The exercise programs for each experimental groups consisted of 20 to 60-minute sessions on three days per week for 24 weeks, and they were performed under the supervision.	Device: Whole-body vibration exercise; 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).
Experimental: High-impact exercise; Depending on their individual calcium and vitamin D intakes, each patient advised to receive supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D.	Other: High-impact exercise; In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
No Intervention: Control; Depending on their individual calcium and vitamin D intakes, each patient received supplemental calcium and vitamin D to ensure a total daily intake of 1,500 mg of calcium and 880 IU of vitamin D. The demographic characteristics of the participants were obtained at the baseline assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Bone Mineral Density at 6 months	The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry	baseline and 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Bone Formation Marker at 3-months and 6-months	The serum osteocalcin (OC) level	baseline, 3-month, 6-month
Change from Baseline Bone Resorption Marker- at 3-months and 6-months	The serum C-terminal telopeptide of type I collagen (CTx) levels	baseline, 3-month, 6-month
Change from Baseline Fall risk at 3-months and 6-months	A computerized static posturography device was used to measure the fall index	baseline, 3-month, 6-month
Change from Baseline Functional Balance at 3-months and 6-months	Timed Up and Go (TUG) test	baseline, 3-month, 6-month
Change from Baseline Health-related Quality of Life at 6 months	Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)	baseline, 6-month
Change from Baseline Depressive Symptoms at 6 months	Beck Depression Inventory	baseline, 3-month, 6-month

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Ekin I Sen, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: IstanbulU-Ekin Sen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No