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临床试验/NCT06760598
NCT06760598已完成不适用

Evaluation of the Relationship Between Thoracic Kyphosis and Quadriceps Muscle Thickness with Balance and Fall Risk in Women with Postmenopausal Osteoporosis

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年7月1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
103
试验地点
2
主要终点
tandem stance and gait test

研究概览

简要总结

To determine the impact of thoracic hyperkyphosis, sarcopenia and quadriceps muscle thickness evaluated by ultrasonography (USG) on balance, fall risk and functional parameters in women with postmenopausal osteoporosis, to assess their interrelationships and to compare the clinical characteristics of sarcopenia and thoracic hyperkyphosis.

详细描述

An observational study was conducted on patients with PMO and/or osteoporotic vertebral fractures according to WHO criteria. One hundred seventeen patients who were 50 years of age or older, with a diagnosis of PMO and/or osteoporotic vertebral fractures according to WHO criteria, who were able to ambulate without any assistive devices were included in the study. Patients with a history of neurological disease which may affect balance and proprioception, visual and vestibular disease, previous major lower extremity surgery or previous vertebra surgery were excluded. The investigators also excluded the patients with advanced heart, liver, or renal failure, stage 4 knee osteoarthritis, psychiatric disorders, and use of any medication affecting the central nervous system.

Age, height, weight, body mass index (BMI), comorbidities, medications, previous surgeries, steroid use, previous fractures and the energy level of these fractures (low or high), fracture location, family history of fractures, alcohol use, smoking, menopausal age and the number of falls in a year were questioned. The FRAX algorithm was used to determine the risk of fracture.

The Cobb angle of thoracic kyphosis was calculated radiographically and QFM thickness was measured from anterior thigh via ultrasonography (USG). The presence of sarcopenia was determined. Balance, fall risk and physical function were evaluated with tandem stance and gait test, Berg balance scale (BBS), Timed up and go test (TUG), hand grip strength, chair stand test (CST).

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
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient who were 50 years of age or older, had postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria,
  • Patient who were able to ambulate without any assistive devices

排除标准

  • History of neurological disease which may affect balance and proprioception,
  • Visual and vestibular disease
  • Previous major lower extremity surgery or previous vertebra surgery
  • Advanced heart, liver, or renal failure
  • Stage 4 knee osteoarthritis
  • Psychiatric disorders
  • Use of any medication affecting the central nervous system.

结局指标

主要结局

tandem stance and gait test

时间窗: Data were collected over a single measurement period of 6 months.

static and dynamic balance was measured.

berg balance scale

时间窗: Data were collected over a single measurement period of 6 months.

Berg balance scale was originally developed for the assessment of postural control and is widely used in many areas of rehabilitation. There are 14 items in the scale, like commonly performing in daily activities sitting and standing balance, transfers, turning, and retrieving objects from the floor. The highest total score is 56 points. If the patient scores between 0-20 points, they are considered wheelchair dependent, between 21-40 points they can walk with assistance and between 41-56 points they are considered independent in mobilization activities.

Timed up and go test

时间窗: Data were collected over a single measurement period of 6 months.

There is a significant relationship between TUG times and functional mobility level

chair stand test

时间窗: Data were collected over a single measurement period of 6 months.

The five times CST evaluates the strength, power, and endurance of the lower extremity muscle group, particularly the quadriceps femoris muscle

quadriceps femoris muscle thickness

时间窗: Data were collected over a single measurement period of 6 months.

evaluated by ultrasound

thoracic kyphosis

时间窗: Data were collected over a single measurement period of 6 months.

The lateral thoracic vertebra radiographs were taken while standing position, the Cobb angle was automatically obtained by computer-aided method by marking the parallel lines drawn from the upper edge of the upper thoracic vertebra (T4), and the lower edge of the lower thoracic vertebra (T12)

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eslem Peker Belene

Medical Doctor

Istanbul University - Cerrahpasa

研究点 (2)

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