Respiratory and Exercise Responses by Body Roundness Index in Obesity
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-60
SponsorBiruni University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionParticipants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Individuals with obesity1 intervention
Trial outcomes
Primary outcomes
1
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 12
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 13
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 14
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 1Secondary outcomes
1
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 12
Ventilation (VE)
Ventilation (Unit of Measure: L/min) during the 6MWT will be assessed using the Spiropalm device.
Time frame
Day 13
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 14
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 1Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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