跳至主要内容
临床试验/NCT06687889
NCT06687889已完成不适用

The Effect of Abdominal and Lumbar Muscle Stiffness Assessed by Elastography on Vertebral Fractures: A Cross-Sectional Study in Women Over 60

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Elastography Measurements

研究概览

简要总结

This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.

The fundamental questions that this study aims to answer are as follows:

Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?

详细描述

Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, aged ≥ 60 years

排除标准

  • History of lumbar spine surgery
  • Spinal infection
  • Severe degenerative scoliosis
  • Chronic kidney failure
  • Liver cirrhosis
  • Bilateral hip arthroplasty

结局指标

主要结局

Elastography Measurements

时间窗: 8 weeks

Measurements were performed using a Mindray ultrasound device (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) with a 15-3 MHz linear probe in Shear Wave Elastography mode. Ultrasound gel was applied between the probe and the skin to enhance contact. The probe was positioned in line with the muscle fibers and perpendicular to the skin, allowing 2D maps of each muscle's shear modulus to be obtained with a spatial resolution of 1 mm and a sampling rate of 1 sample per second. Images obtained during elastography measurements were analyzed using Q-Box to evaluate Young's modulus (kPa) and SWW (m/s). Shear modulus measurements were taken at rest and at the end of contraction. Muscle thickness measurements were recorded in mm by measuring the distance between the two fascias. All measurements were performed three times, and the average of these measurements will be used for statistical analysis

次要结局

  • Bone Mineral Density Measurement (DEXA)(8 weeks)
  • Berg balance scale(8 weeks)
  • Functional Reach Test(8 weeks)
  • Timed Up and Go Test(8 weeks)

研究者

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

Handan Elif Nur BAYRAKTAR

Specialist

Samsun Education and Research Hospital

研究点 (1)

Loading locations...

相似试验