Clinical trial

Respiratory and Exercise Responses by Body Roundness Index in Obesity

Opening soon · Not applicable · 0 countries · Registry ID NCT07595822

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

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

Treatments and study arms

Observational

Other

Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.

Primary outcomes

Forced vital capacity (FVC)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)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)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 ratioDay 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)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.

Study locations

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No public site location was included in this record. Check the original registry for updates.