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临床试验/NCT06017245
NCT06017245已完成不适用

Could the Bone-Myoregulation Reflex Explain the Development of Sarcopenia in Postmenopausal and Senile Osteoporosis?

Istanbul Physical Medicine Rehabilitation Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Bone myoregulation reflex latency

研究概览

简要总结

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis

详细描述

Bone and skeletal muscle are in a single unit that interacts with each other structurally and functionally. While myokines synthesized and released in skeletal muscle modulate the bone formation and destruction process, osteokines synthesized and released by bone cells have positive or negative effects on muscle (4,5,6,7,8,9). In addition to humoral crosstalk mechanisms between muscle and bone, there is also a neuronal crosstalk mechanism defined as bone myoregulation reflex. The aim of this study is to determine the contribution of bone myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal and senile osteoporosis (10,11,12,13,14). Osteoporotic cases would be determined by standard DXA measurements.

The vibration will be applied with the PowerPlate® Pro5 whole-body vibration (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.

Surface EMG recordings will be taken from the right soleus muscle using the bipolar technique. A pair of self-adhesive Ag/AgCl (Redline®) electrodes will be adhered to the skin according to the SENIAM protocol(2). Recordings will be taken in the 1-500 Hz frequency band. Surface electromyography (EMG) recordings will be taken with a PowerLab ® (ADInstruments, Oxford, UK) data recorder with a sample rate of 20 KHz. EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK). The acceleration measurement data will be recorded with the PowerLab (ADInstrument London) data acquisition simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 20 KHz.

研究设计

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

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For healthy young adults control Healthy volunteers aged 20-45 years
  • For postmenopausal osteoporosis Hip DXA T-score (neck or total hip) < -2.5
  • For the Senile osteoporosis Over 65 years Male Hip DXA T-score (neck or total hip) < -2.5 Female

排除标准

  • Osteopenic cases
  • Possible sarcopenia (according to EWGSOP2 criteria)
  • Kidney stone
  • Panic attack story
  • Secondary osteoporosis
  • Those with polyneuropathy, central nervous system disease clinic/history
  • Myopathies (steroid, vitamin D deficiency, primary muscle diseases, etc.)
  • Cases with lesions on the soleus skin
  • History of fracture in lower extremity, joint prosthesis
  • Lower extremity active/acute thrombophlebitis

结局指标

主要结局

Bone myoregulation reflex latency

时间窗: up to 2 weeks

It was defined as the period between the onset of effective mechanical stimulation and the onset of the reflex in surface electromyography.

次要结局

未报告次要终点

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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