Respiratory and Exercise Responses by Body Roundness Index in Obesity

NCT07595822 | Not Yet Recruiting

• 1 other identifier: Obesity1052026
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Day 1

Secondary Outcomes (8)

• 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

Study Arms (1)

Individuals with obesity

Other: Observational

Interventions

Observational OTHER

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

Individuals with obesity

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

MeSH Terms

Conditions

Obesity

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Buket Akinci, Prof. Dr.

CONTACT

+90 505 641 56 92; bakinci@biruni.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share