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临床试验/NCT03910348
NCT03910348已完成不适用

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

Istanbul University0 个研究点目标入组 58 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
主要终点
Change from Baseline Bone Mineral Density at 6 months

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Whole body vibration exercise

Experimental

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.

干预措施: Whole-body vibration exercise (Device)

High-impact exercise

Experimental

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.

干预措施: High-impact exercise (Other)

Control

No Intervention

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.

结局指标

主要结局

Change from Baseline Bone Mineral Density at 6 months

时间窗: baseline and 6 month

The bone mineral density of the lumbar spine, femoral neck were measured with a dual energy x-ray absorptiometry

次要结局

  • Change from Baseline Functional Balance at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Bone Resorption Marker- at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Fall risk at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Health-related Quality of Life at 6 months(baseline, 6-month)
  • Change from Baseline Bone Formation Marker at 3-months and 6-months(baseline, 3-month, 6-month)
  • Change from Baseline Depressive Symptoms at 6 months(baseline, 3-month, 6-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekin Ilke Sen

Medical doctor

Istanbul University

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