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临床试验/NCT01676883
NCT01676883已完成不适用

Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Body composition

研究概览

简要总结

Studies have confirmed the association between plantar callosities and severely obese individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for estimating body composition because it is easy to use, noninvasive, relatively inexpensive, and can be performed across a wide range of subjects.

Our hypotheses for this study are: (1)plantar callosities influence the body composition measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the percentage of body fat compared with air-displacement plethysmography (BodPod).

详细描述

As the prevalence of obesity continues to increase, many parts of the world are progressively facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe obesity is characterized by large alterations in body compartments when compared to overweight or non-obese individuals, there is a need for the evaluation of the body composition of severely obese persons. There is very few published research available on what methods of body composition measurements can be used on this population.

Other studies have also shown the tendency of bioelectrical impedance analysis (BIA) instruments to underestimate percentage of fat mass and overestimate the percentage of fat free nass, compared with gold-standard techniques. We think that plantar callosities might have contributed to the lack of accurate measurements. Thus, the primary aim of this study is to determine whether plantar callosities influence the validity of body composition measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the validity of the body composition measurements obtained by BIA (InBody 720) in severely obese individuals, using air-displacement plethysmography (BodPod) as the gold standard. Additionally, we will explore various sources of error using test-retest reliabilities by measuring body composition with different arm postures. We will examine this further to rule out the possibility of "positions of measurement" as a potential confounder of this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (18-50 years old)
  • •class 2 and 3 obesity (BMI > 35 kg/m2)
  • •moderate to severe callosities

排除标准

  • •Intractable plantar keratosis (IPK), which are painful plantar calluses located under the metatarsal heads.
  • •pregnancy
  • •menopause
  • •diseases that cause water retention (edema, renal insufficiency, hypertension, etc.)

研究组 & 干预措施

body composition assessment

Experimental

Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)

干预措施: Bioelectric impedance (Device)

body composition assessment

Experimental

Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)

干预措施: Air displacement plethysmography (Device)

结局指标

主要结局

Body composition

时间窗: 1 day

Bioelectric impedance (using InBody 720) at three standardized arm postures angled at 15, 45 and 90 degrees, in randomized order; Air displacement plethysmography (ADP,using BodPod)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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