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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03910348
• Other study ID #: IstanbulU-Ekin Sen
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Therapy
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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).

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Bone Formation Marker at 3-months and 6-months	The serum osteocalcin (OC) level	baseline, 3-month, 6-month
Secondary	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
Secondary	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
Secondary	Change from Baseline Functional Balance at 3-months and 6-months	Timed Up and Go (TUG) test	baseline, 3-month, 6-month
Secondary	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
Secondary	Change from Baseline Depressive Symptoms at 6 months	Beck Depression Inventory	baseline, 3-month, 6-month