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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03910348
Other study ID # IstanbulU-Ekin Sen
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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