Respiratory and Exercise Responses by Body Roundness Index in Obesity

May 12, 2026 updated by: Buket AKINCI, Biruni University

Evaluation of Respiratory Performance and Exercise Responses According to Body Roundness Index in Individuals With Obesity

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Individuals with obesity
Other: Observational
Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced vital capacity (FVC)
Time Frame: 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.
Day 1
Maximum Inspiratory Pressure (MIP)
Time Frame: 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.
Day 1
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 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.
Day 1
FEV1/FVC ratio
Time Frame: 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.
Day 1
Maximal expiratory pressure (MEP)
Time Frame: 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.
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise capacity
Time Frame: Day 1
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.
Day 1
Ventilation (VE)
Time Frame: Day 1
Ventilation (Unit of Measure: L/min) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Body fat mass index (kg)
Time Frame: Day 1
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.
Day 1
Body Roundness Index
Time Frame: Day 1
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).
Day 1
Peak ventilation (VEpeak)
Time Frame: Day 1
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Peak breathing reserve (BRpeak)
Time Frame: Day 1
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Inspiratory capacity (IC)
Time Frame: Day 1
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Body muscle mass (kg)
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Obesity1052026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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