Evaluation of Respiratory Performance and Exercise Responses According to Body Roundness Index in Individuals With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Forced vital capacity (FVC)
研究概览
简要总结
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.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Individuals with obesity
干预措施: Observational (Other)
结局指标
主要结局
Forced vital capacity (FVC)
时间窗: 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.
Maximum Inspiratory Pressure (MIP)
时间窗: 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.
Forced Expiratory Volume in 1 second (FEV1)
时间窗: 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.
FEV1/FVC ratio
时间窗: 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.
Maximal expiratory pressure (MEP)
时间窗: 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.
次要结局
- Exercise capacity(Day 1)
- Ventilation (VE)(Day 1)
- Body fat mass index (kg)(Day 1)
- Body Roundness Index(Day 1)
- Peak ventilation (VEpeak)(Day 1)
- Peak breathing reserve (BRpeak)(Day 1)
- Inspiratory capacity (IC)(Day 1)
- Body muscle mass (kg)(Day 1)
研究者
Buket AKINCI
Prof. Dr.
Biruni University