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临床试验/NCT04259697
NCT04259697Unknown不适用

Comparison of the Effects of Clinical Pilates and Whole Body Vibration Exercises on Strength, Flexibility, Balance, Bone Turnover Markers and Quality of Life in Postmenopausal Osteoporotic Women

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
2
主要终点
The maximum hold time on unipedal stance and on tandem stance.

研究概览

简要总结

The aim is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women on strength, flexibility, balance, bone turnover markers and quality of life.

详细描述

The aim of this study is to compare the effects of clinical pilates and whole body vibration exercises in postmenopausal osteoporotic women in terms of strength, flexibility, balance, bone turnover markers and quality of life. Thirty-four women who are diagnosed with postmenopausal osteoporosis will be recruited into the study. Participants will be divided into two groups: (1) clinical pilates group, (2) vibration exercises group. Exercise programs will be performed two times per week for twelve weeks. The strength of the extensor muscles of the hip, knee, back, elbow will be measured with a hand-held dynamometer. Flexibility will be assessed measuring the fingertip-to-floor distance in flexion and lateral bending. The balance performance will be assessed using the timed up and go test, Tetrax fall index and the maximum hold time on unipedal stance and on tandem stance. The short form-12 questionnaire will be used to assess the quality of life. Also, bone turnover markers will be measured. All assessments will be performed before and after exercise programs.

研究设计

研究类型
Interventional
分配方式
Non 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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being in the postmenopausal period
  • Having body mass index equal to or greater than 18,5 kg/m²
  • A lack of regular exercise
  • Having been diagnosed with osteoporosis
  • Having the ability to walk independently

排除标准

  • Having a cardiopulmonary problem that may prevent participating in exercise programs
  • Having kidney stones
  • Being diagnosed with diabetes
  • Presence of epilepsy
  • Having cardiological problems such as arrhythmia, using a pacemaker, hypertension
  • Having neurological disorders such as Parkinson, stroke, multiple sclerosis, neuropathy
  • Having surgery in the last 6 months

结局指标

主要结局

The maximum hold time on unipedal stance and on tandem stance.

时间窗: Change in the maximum hold time from baseline to twelve weeks

The maximum hold time will be calculated to assess static balance.

Plasma sclerostin concentration

时间窗: Change in plasma sclerostin concentration from baseline to twelve weeks

Plasma sclerostin concentration will be measured to assess the process of bone resorption and formation.

Timed up and go test

时间窗: Change in Timed up and go test from baseline to twelve weeks

Timed up and go test will be used to assess dynamic balance.

Dual-energy X-ray absorptiometry of hip and lumbar spine

时间窗: Change in the Dual-energy X-ray absorptiometry of hip and lumbar spine from baseline to twelve weeks

Dual-energy X-ray absorptiometry of hip and lumbar spine will be measured to assess bone density.

Strength

时间窗: Change in strength measures from baseline to twelve weeks

The strength of the extensor muscles of the hip, knee, back, elbow will be assessed with a hand-held dynamometer.

Tetrax fall index

时间窗: Change in Tetrax fall index from baseline to twelve weeks

Tetrax fall index will be calculated to determine fall risk.

The short form-12 questionnaire

时间窗: Change in quality of life measure from baseline to twelve weeks

The short form-12 questionnaire will be used to assess quality of life. The total score can range from 0 to 100. Lower SF-12 score indicated poorer physical and mental health.

Urinary deoxypyridinoline

时间窗: Change in urinary deoxypyridinoline level from baseline to twelve weeks

Urinary deoxypyridinoline level will be measured to assess bone resorption.

Flexibility

时间窗: Change in flexibility measures from baseline to twelve weeks

Flexibility wil be assessed measuring the fingertip-to-floor distance in flexion and lateral bending.

次要结局

未报告次要终点

研究者

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

Burcu Ece KORKMAZ

Principal Investigator

Dokuz Eylul University

研究点 (2)

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