Respiratory and Exercise Responses by Body Roundness Index in Obesity

N/ANot Yet RecruitingNCT07595822

Biruni University120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Obesity

Interventions

ObservationalOTHER

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

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Forced vital capacity (FVC)

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.

Time frame: Day 1

Maximum Inspiratory Pressure (MIP)

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.

Time frame: Day 1

Forced Expiratory Volume in 1 second (FEV1)

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.

Time frame: Day 1

FEV1/FVC ratio

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.

Time frame: Day 1

Maximal expiratory pressure (MEP)

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.

Time frame: Day 1

Secondary Outcomes

Exercise capacity

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.

Time frame: Day 1

Ventilation (VE)

Ventilation (Unit of Measure: L/min) during the 6MWT will be assessed using the Spiropalm device.

Time frame: Day 1

Body fat mass index (kg)

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.

Time frame: Day 1

Body Roundness Index

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).

Time frame: Day 1

Peak ventilation (VEpeak)

Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.

Time frame: Day 1

Peak breathing reserve (BRpeak)

Body muscle mass (kg)

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.

Time frame: Day 1

Respiratory and Exercise Responses by Body Roundness Index in Obesity

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts