휴대용 체성분 분석기(Fitrus Light)와 Inbody570의 재현성 및 일치도 평가 연구

다국어 초록 (Multilingual Abstract)

Background The market for portable body composition analyzers has ex panded rapidly in response to increasing demand for personalized digital he althcare. Bioelectrical impedance analysis (BIA) accounts for a substantial proportion of body composition assessment methods and remains one of th e most widely used techniques. However, conventional BIA-based devices are often costly and limited in portability, which restricts their applicability in routine clinical and community-based settings. In Korean Medicine, body composition parameters are closely associated with pathological patterns su ch as pi–wei deficiency (脾胃虛弱), phlegm-dampness (痰濕), and qi stagnat ion (氣滯), and are frequently used as indirect indicators of systemic imbal ance. Although interventions including acupuncture, moxibustion, and Chuna manual therapy are known to influence circulation, muscle tone, and fluid r egulation, objective tools for repeatedly quantifying these changes remain li mited. Portable digital devices capable of providing quantitative body compo sition data may therefore support objective monitoring in integrative medic al practice.
Objective This study aimed to evaluate the intra-device reliability and inte r-device reproducibility of the portable body composition analyzer Fitrus L ight, in comparison with a standard clinical BIA device, the InBody 570, an d to explore its applicability as an objective monitoring tool in Korean Med icine–based and acupuncture-oriented clinical practice.
Methods A cross-sectional observational study was conducted in 50 adults who underwent sequential body composition assessments using both the te st device (Fitrus Light) and the reference device (InBody 570), with two r epeated measurements per device. The order of device application was ran domized to minimize measurement-order bias. The primary outcome was p ercent body fat (PBF, %), and secondary variables included body fat mass (FM), skeletal muscle mass (SMM), total body water (TBW), and basal me tabolic rate (BMR). Reliability and reproducibility were evaluated using intr aclass correlation coefficients (ICC), and Cohen’s d was calculated to esti mate the magnitude of differences between repeated measurements.
Conclusion Fitrus Light demonstrated high intra-device reliability and inter -device reproducibility across all measured body composition variables, wit h ICC values ranging from 0.90 to 0.974. For the primary variable, PBF, th e inter-device ICC was 0.903, with a standard error of measurement (SE M) of 1.99, indicating stable measurement performance. These findings sug gest that Fitrus Light provides body composition measurements comparable to those obtained with a conventional clinical BIA device, while offering ad vantages in portability and ease of use. From an integrative medicine persp ective, this device may serve as a practical tool for objectively monitoring changes in muscle mass, body water, and fat distribution associated with a cupuncture, moxibustion, Chuna therapy, or herbal interventions. Accordingl y, Fitrus Light has potential utility as a digital measurement platform suppo rting data-informed clinical assessment and longitudinal monitoring in Kore an Medicine and community healthcare settings.

Key words: Bioelectrical Impedance Analysis; Portable Body Composition A nalyzer; Fitrus Light; Reliability; Korean Medicinelation Coefficient (ICC); A cupuncture; Korean Medicine; Digital Biomarker.

목차 (Table of Contents)

• 목 차 ⅰ
• 표 목 차 ⅲ
• 그림목차 ⅴ
• Ⅰ. 서 론 5
• Ⅱ. 연구 방법 7
• 1. 인체 적용 시험기기 7
• 1) 피트러스 라이트, Fitrus Light (FRL-B10) 7
• 2) 임피던스 체지방 측정기, InBody 570 8
• 2. 인체적용시험 대상자 9
• 1) 연구 대상자 9
• 2) 선정기준 10
• 3) 제외기준 10
• 4) 대상자 수 산정 11
• 3. 인체 적용시험 방법 12
• 1) 시험디자인 12
• 2) 검사항목 및 관찰 일정 13
• 3) 시험 중지 및 탈락기준 15
• 4. 측정 신뢰도 및 재현성 평가 16
• 1) 평가 기준 16
• 2) 통계분석 17
• 5. 이상 반응 19
• 1) 안전성 평가 19
• 2) 이상 반응 평가 20
• Ⅲ. 연구 결과 21
• 1. 대상자 모집 21
• 2. 인구학적 정보 및 기저 특성 23
• 1) 인구학적 정보 23
• 3. 측정 신뢰도 및 재현성 평가 26
• 1) 1차 평가변수 : 기기 내 재현성 27
• 2) 2차 평가변수 : 기기 간 일치도 29
• 3) 3차 평가변수 : 기기 간 상관성 32
• 4. 안전성 평가 34
• 1) 이상 반응 34
• 2) 활력 징후 기반 안전성 평가 34
• Ⅳ. 고 찰 35
• Ⅴ. 결 론 38
• 참 고 문 헌 39