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Respiratory and Exercise Responses by Body Roundness Index in Obesity

12. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Individuals with obesity
Andet: Observational
Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced vital capacity (FVC)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exercise capacity
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Day 1
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Peak breathing reserve (BRpeak)
Tidsramme: Day 1
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Inspiratory capacity (IC)
Tidsramme: Day 1
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Body muscle mass (kg)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juni 2026

Primær færdiggørelse (Anslået)

20. november 2026

Studieafslutning (Anslået)

9. december 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Obesity1052026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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