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临床试验/NCT06829004
NCT06829004尚未招募不适用

Calf Circumference Adjusted for Body Composition to Assess Muscle Mass

University of Tartu0 个研究点目标入组 150 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
尚未招募
入组人数
150
主要终点
Accuracy of corrected calf circumference in estimating muscle mass

研究概览

简要总结

Muscle mass is a critical indicator for malnutrition and sarcopenia assessment. Anthropometric measurements like calf circumference (CC) could be a simple and cost-effective alternative when gold standard methods are not available. However, CC is probably less accurate for estimating muscle mass in female patients and patients with obesity. This study investigates whether adjusting CC using mid-upper arm circumference (MUAC) improves muscle mass estimation in patients with obesity. If validated, this correction method would serve as a simple clinical tool for muscle mass assessment.

详细描述

The patient's demographic data including age, sex, primary diagnosis, and diagnoses of co-morbidities are found by the investigator in the medical history (eHL). The researcher codes the current main diagnosis and its severity: we use the World Health Organization's ICD-11 classification (icd.who.int/browse11/l-m/en) and a three-point scale where 1 is mild and 3 is severe.

The patient will be interviewed for changes in body weight and food intake. Anthropometric measurements will be recorded, including height, weight, body mass index (BMI), mid upper arm circumference, calf circumference, and waist circumference.

The accurate muscle mass measurement will be done using total body densitometry (DEXA) scan, that was already ordered for other purposes. Bone mineral density (BMD) from DEXA scan will be recorded. This allows us to see if calf circumference can be used for estimating bone mineral density. Patients will be followed up one year after data collection. Follow up will involve calling the patients and asking them questions from the SarQoL (sarcopenia quality of life questionnaire)

Calf circumference will be measured using non-elastic tape at the widest part of the dominant calf in the seated position with the weight evenly distributed on both feet (1). Mid upper arm circumference will be measured at the midpoint between the acromial surface of the scapula and the olecranon process of the elbow over the dominant arm when bent at 90 degrees. Waist circumference will be measured using measuring tape 2.5 cm above the umbilicus in a standing position. Waist circumference is used to define obesity as it is a marker of abdominal obesity (2). We aim to keep the interview no longer than 10 minutes.

Demographic and anthropometric data will be analyzed using descriptive statistics. The sensitivity, specificity of muscle mass measurements will be calculated. Corrected calf circumference will be compared to DEXA (gold standard diagnostic tool) and new cutoffs will be defined by using Receiver Operating Characteristic curves. Statistical analyses will be performed using R.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Booked to undergo bone density scanning (DEXA) at Tartu University Hospital

排除标准

  • Isolation for infectious disease Pregnancy and lactation Unable to understand or follow study protocol

结局指标

主要结局

Accuracy of corrected calf circumference in estimating muscle mass

时间窗: 15 months

Accuracy of corrected calf circumference in estimating muscle mass in comparison to densitometry (DEXA) used as a gold standard

次要结局

  • Comparison of accuracy of corrected calf measurement results in female patients(15 months)
  • Comparison of accuracy of corrected calf measurement results in obese patients(15 months)
  • Quality of life with and without corrected results of anthropometry(15 months)
  • Bone density estimated from corrected calf circumference(15 months)

研究者

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

Alastair Forbes

Visiting Professor

University of Tartu

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