Respiratory and Exercise Responses by Body Roundness Index in Obesity
2026년 5월 12일 업데이트: Buket AKINCI, Biruni University
Evaluation of Respiratory Performance and Exercise Responses According to Body Roundness Index in Individuals With Obesity
This observational study aims to evaluate respiratory performance and exercise responses according to Body Roundness Index (BRI) in individuals with obesity.
Participants will undergo anthropometric and body composition assessments, respiratory muscle strength testing, pulmonary function evaluation, and a six-minute walk test.
Exercise-related ventilatory responses, dyspnea, fatigue perception, oxygen saturation, and heart rate responses will also be assessed.
The study seeks to investigate the relationship between BRI and cardiopulmonary performance and to determine whether BRI may serve as a useful indicator of obesity-related functional limitations and exercise capacity.
연구 개요
연구 유형
관찰
등록 (추정된)
120
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Buket Akinci, Prof. Dr.
- 전화번호: +90 505 641 56 92
- 이메일: bakinci@biruni.edu.tr
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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예
샘플링 방법
비확률 샘플
연구 인구
The study population will consist of adults with obesity between 25 and 60 years of age with a body mass index (BMI) ≥ 30 kg/m² according to the World Health Organization classification.
Participants will be recruited on a voluntary basis and will undergo anthropometric, respiratory, and exercise capacity assessments.
설명
Inclusion Criteria:
- Individuals between 25 and 60 years of age
- Individuals with a body mass index (BMI) ≥ 30 kg/m² according to the World Health Organization (WHO) classification
- Individuals who voluntarily agree to participate in the study
Exclusion Criteria:
- Individuals with a Charlson Comorbidity Index (CCI) score of 3 or higher
- Individuals with uncontrolled arrhythmia, hypertension, heart failure, diabetes mellitus, or unstable angina pectoris
- Individuals with cooperation difficulties, orthopedic disorders, or neurological problems that may interfere with assessment procedures
- Individuals with a history of lower extremity injury or surgery within the last six months
- Individuals diagnosed with diabetes mellitus and presenting complications such as nephropathy, retinopathy, or neuropathy
- Individuals with concomitant chronic respiratory disease
- Individuals with acute infection
- Individuals with middle ear pathologies (e.g., tympanic membrane rupture or otitis)
- Individuals with a history of spontaneous or trauma-related pneumothorax
- Current smokers
- Pregnant individuals
- Individuals with a STOP-Bang score of 3 or higher
- Individuals currently participating in a structured weight-loss diet program or receiving medical treatment for weight reduction during the assessment period
- Individuals who underwent endoscopic intervention and/or bariatric surgery within the last year
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Individuals with obesity
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Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Forced vital capacity (FVC)
기간: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
Forced vital capacity (FVC) will be measured.
Values will be recorded in liter and as percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
Maximum Inspiratory Pressure (MIP)
기간: Day 1
|
Respiratory muscle strength assessment will be performed using an intraoral pressure measurement device (MicroRPM, Micro Medical, United Kingdom) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria (ATS/ERS, 2002).
Measurements will be conducted in a seated position while wearing a nose clip.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
For maximal inspiratory pressure (MIP) measurement, participants will perform a maximal inspiratory effort through the mouth for a few seconds.
Measurements will be repeated three times, and the best value meeting standardization criteria will be recorded in cmH₂O.
|
Day 1
|
|
Forced Expiratory Volume in 1 second (FEV1)
기간: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
FEV1 ratio will be measured.
Values will be recorded percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
FEV1/FVC ratio
기간: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
FEV1/FVC ratio will be measured.
Values will be recorded percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
Maximal expiratory pressure (MEP)
기간: Day 1
|
Respiratory muscle strength assessment will be performed using an intraoral pressure measurement device (MicroRPM, Micro Medical, United Kingdom) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria (ATS/ERS, 2002).
Measurements will be conducted in a seated position while wearing a nose clip.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
For maximal expiratory pressure (MEP) measurement, a maximal expiratory effort will be performed for a few seconds, and the values will be recorded.
Measurements will be repeated three times, and the best value meeting standardization criteria will be recorded in cmH₂O.
|
Day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Exercise capacity
기간: Day 1
|
Exercise capacity will be evaluated using the Six-Minute Walk Test (6MWT) according to the American Thoracic Society (ATS) guidelines with the Spiropalm 6MWT device (COSMED, Italy) (ATS, 2002).
Before the test, participants will rest for at least 10 minutes, and baseline measurements including heart rate, blood pressure, oxygen saturation, dyspnea, and leg fatigue will be recorded.
The test will be performed in a 30-meter indoor corridor, and participants will be instructed to walk as fast as possible for six minutes.
Total walking distance will be recorded in meters.
Heart rate, oxygen saturation, dyspnea, and fatigue levels will be reassessed after the test.
|
Day 1
|
|
Ventilation (VE)
기간: Day 1
|
Ventilation (Unit of Measure: L/min) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Body fat mass index (kg)
기간: Day 1
|
Body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Participants will be informed about the test protocol and instructed to fast for 8-12 hours before the assessment, arrive with an empty bladder, and avoid fluid intake, food consumption, and vigorous physical activity prior to the measurements.
Assessments will be performed during daytime at a room temperature of 25°C.
Participants will be measured while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Body Roundness Index
기간: Day 1
|
Body Roundness Index (BRI) will be calculated using waist circumference and height measurements according to the standardized BRI formula.
The BRI is a continuous index with no fixed minimum or maximum value.
Higher BRI values indicate greater body roundness and higher adiposity (worse outcome).
|
Day 1
|
|
Peak ventilation (VEpeak)
기간: Day 1
|
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Peak breathing reserve (BRpeak)
기간: Day 1
|
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
기간: Day 1
|
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Body muscle mass (kg)
기간: Day 1
|
Body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Participants will be informed about the test protocol and instructed to fast for 8-12 hours before the assessment, arrive with an empty bladder, and avoid fluid intake, food consumption, and vigorous physical activity prior to the measurements.
Assessments will be performed during daytime at a room temperature of 25°C.
Participants will be measured while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 20일
기본 완료 (추정된)
2026년 11월 20일
연구 완료 (추정된)
2026년 12월 9일
연구 등록 날짜
최초 제출
2026년 5월 7일
QC 기준을 충족하는 최초 제출
2026년 5월 12일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Obesity1052026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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