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Respiratory and Exercise Responses by Body Roundness Index in Obesity

2026年5月12日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

観察的

入学 (推定)

120

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Individuals with obesity
他の：Observational
Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Forced vital capacity (FVC)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Exercise capacity
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：Day 1
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Peak breathing reserve (BRpeak)
時間枠：Day 1
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Inspiratory capacity (IC)
時間枠：Day 1
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
Day 1
Body muscle mass (kg)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Biruni University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月20日

一次修了 (推定)

2026年11月20日

研究の完了 (推定)

2026年12月9日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月19日

QC基準を満たした最後の更新が送信されました

2026年5月12日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • Obesity1052026

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はい

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