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

Not Applicable

Completed

• Conditions: Exercise Therapy; Osteoporosis, Postmenopausal
• Interventions: Other: High-impact exercise; Device: Whole-body vibration exercise

• Registration Number: NCT03910348
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-05
• Study Completion: 2011-09
• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-impact exercise	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.
Whole body vibration exercise	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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