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临床试验/NCT06786195
NCT06786195已完成不适用

Is the Bone Myoregulation Reflex Response to Weight-Bearing Activities Low in 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 22 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Bone myoregulation reflex latency

研究概览

简要总结

Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bones. It often remains asymptomatic in its early stages but can lead to serious health problems, particularly fractures.The mechanostat theory explains that bone mass is regulated by mechanical loading. Increased activity stimulates bone formation, while decreased activity promotes bone resorption. The "bone reflex" concept further suggests that the nervous system plays a crucial role in this process by regulating both bone metabolism (osteoregulation) and muscle activity (myoregulation) in response to mechanical loading.

详细描述

Background and Objectives:Osteoporosis is a systemic skeletal disease characterized by weakened and fragile bone tissue. Typically asymptomatic in its early stages, it can lead to severe health consequences, particularly fractures. Bone mineral density (BMD) measurements, as defined by the World Health Organization, are considered the gold standard for diagnosing osteoporosis. The prevalence of osteoporosis is on the rise due to the aging population and the influence of lifestyle factors.

Recently, the bone reflex has been defined, suggesting that the central nervous system controls the local regulatory mechanisms described by Wolf and Frost. The bone reflex describes how osteocytes are stimulated by mechanical loading, leading to the neural regulation of bone formation and resorption according to mechanical needs (bone osteoregulation reflex). Additionally, it describes a mechanism by which the nervous system reflexively regulates the activity of surrounding muscles to optimally position the bone to resist applied mechanical load (bone myoregulation reflex).

Methods: This study employs a quasi-experimental design. The study will be conducted with a total of 22 patients aged 60-70, men. Diagnosis of osteoporosis was made according to the World Health Organization classification. Individuals with a T-score of -2.5 or below were classified as having osteoporosis. Participants will be divided into two groups: a group with osteoporosis (Group 1) and a group without osteoporosis (Group 2).

Procedures:

Bone myoregulation reflex activity of the soleus and tibialis anterior muscles will be assessed in both groups during whole-body vibration and jumping using surface electromyography.

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
60 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • DXA T-scores ≤-2.5 (osteoporotic) or T-scores > -1 (no bone loss)
  • Individuals who agree to participate in the study

排除标准

  • History of musculoskeletal surgery within the past year
  • Individuals with health conditions that severely affect mobility
  • Vestibular disorders
  • Visual impairments
  • Other rheumatic, psychiatric, or severe neurological diseases
  • Chronic decompensated cardiac, renal, or hepatic insufficiency
  • Panic attacks
  • Individuals with skin lesions on the soleus muscle
  • History of fractures or prostheses in the lower extremities
  • History of kidney stones
  • 2+ or more edema in the lower extremities, lymphedema
  • History of malignancy
  • History of osteomalacia or vitamin D deficiency

结局指标

主要结局

Bone myoregulation reflex latency

时间窗: Through study completion, an average of 8 weeks.

The measurement will be taken as the time difference between the moment of mechanical stimulation and the onset of the reflex response in the EMG. The unit of measurement for latency is milliseconds.

Bereitschafts (Readiness) Potential

时间窗: Through study completion, an average of 8 weeks.

It refers to the myoelectric activity in the tibialis anterior and soleus muscles just before jumping. The onset time of this myoelectric activity will be evaluated in milliseconds, and the amplitude of this activity will be measured in millivolts.

次要结局

  • Soleus H-reflex(Through study completion, an average of 8 weeks)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eser Kalaoglu

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (2)

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