Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern
2026年5月15日 更新者：Buket AKINCI、Biruni University
Investigation of the Relationship Between Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Individuals With Obesity and a Restrictive Ventilatory Pattern
This observational cross-sectional study aims to examine the relationship between body composition, functional capacity, and respiratory muscle endurance in individuals with obesity and a restrictive ventilatory pattern.
A total of 100 adults aged 25-60 years with a body mass index (BMI) ≥30 kg/m² and restrictive pulmonary function findings will be enrolled.
Participants will evaluate body composition assessment using bioelectrical impedance analysis, pulmonary function testing by spirometry, respiratory muscle strength and endurance measurements, and functional capacity evaluation using the Six-Minute Walk Test (6MWT).
The aim of this study is to evaluate the relationships between stem cell count (SCC), a novel anthropometric indicator called WWI, trunk muscle mass, and functional capacity in obese individuals with a restrictive ventilatory pattern.
調査の概要
状態
まだ募集していません
条件
研究の種類
観察的
入学 (推定)
100
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
- 名前：Buket Akinci, Prof. Dr.
- 電話番号：+90 505 6415692
- メール：bakinci@biruni.edu.tr
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
Obese Individuals with Restrictive Ventilatory Pattern
説明
Inclusion Criteria:
- Individuals aged between 25 and 60 years
- Individuals with a body mass index (BMI) ≥ 30 kg/m² according to the World Health Organization (WHO) classification
- Individuals demonstrating a restrictive ventilatory pattern (FVC < 80% predicted)
- 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 impairments, orthopedic, or neurological conditions that may interfere with assessment or treatment
- Individuals with a history of lower extremity injury or surgery within the last six months
- Individuals diagnosed with diabetes mellitus who have 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 loss during the assessment period
- Individuals who have undergone 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 |
|---|---|
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Obese Individuals with Restrictive Ventilatory Pattern
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Participants will undergo a comprehensive assessment including pulmonary function testing using spirometry, body composition analysis using bioelectrical impedance analysis (BIA), respiratory muscle strength and endurance evaluation, and functional capacity assessment with the Six-Minute Walk Test (6MWT).
Anthropometric measurements including body weight, height, waist circumference, hip circumference, and waist-to-height ratio will also be recorded.
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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 |
|---|---|---|
|
Functional capacity
時間枠：Day 1
|
Participants' exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) according to the American Thoracic Society (ATS) guidelines with the Spiropalm 6MWT system (Cosmed, Italy) (ATS, 2002).
The test will be performed in a 30-meter indoor corridor following a minimum 10-minute rest period.
Heart rate, blood pressure, oxygen saturation, dyspnea, and leg fatigue levels will be recorded before and after the test.
Participants will be instructed to walk as fast as possible for six minutes and may rest or terminate the test if severe symptoms occur.
Total walking distance will be recorded in meters, and any interruptions or symptoms during the test will be documented.
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Day 1
|
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Respiratory Muscle Endurance
時間枠：Day 1
|
Participants' respiratory muscle endurance will be assessed using an inspiratory muscle training device (POWERbreathe® K-Series K3, POWERbreathe International Ltd, UK).
Measurements will be performed in a seated position with a nose clip applied and the device placed in the mouth.
The assessment will be conducted using an incremental threshold loading protocol.
At the beginning of the test, the threshold pressure will be set at 20% of the participant's maximal inspiratory pressure (MIP).
Participants will be instructed to complete 30 breaths over a two-minute period.
Individuals who tolerate this level will progress to subsequent stages with gradually increasing loads of 40%, 60%, 80%, and 100% of MIP, respectively.
Oxygen saturation and heart rate will be recorded before and after the test using a pulse oximeter.
Participants will also be informed that they may remove the device from their mouth and terminate the test at any time in the event of any discomfort or adverse symptoms.
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Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body fat mass
時間枠：Day 1
|
Participants' 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 testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
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Day 1
|
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Forced vital capacity (FVC)
時間枠：Day 1
|
Forced vital capacity (FVC) will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded.
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Day 1
|
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Ventilation (VE)
時間枠：Day 1
|
Ventilation (VE) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle mass
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 testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Forced expiratory volume in the first second (FEV1)
時間枠：Day 1
|
Forced expiratory volume in the first second (FEV1) will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded.
|
Day 1
|
|
FEV1/FVC ratio
時間枠：Day 1
|
FEV1/FVC ratio will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded
|
Day 1
|
|
Peak ventilation (VEpeak)
時間枠：Day 1
|
Peak ventilation (VEpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
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Peak breathing reserve (BRpeak)
時間枠：Day 1
|
Peak breathing reserve (BRpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
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Respiratory frequency (RF)
時間枠：Day 1
|
Respiratory frequency (RF) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
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Day 1
|
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Inspiratory capacity (IC)
時間枠：Day 1
|
Inspiratory capacity (IC) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
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Body muscle percentage
時間枠：Day 1
|
Body muscle percentage (%) 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 testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Weight-Adjusted Waist Index (WWI)
時間枠：Day 1
|
Weight-Adjusted Waist Index (WWI) will be calculated by dividing waist circumference (cm) by the square root of body weight (kg).
|
Day 1
|
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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30日
一次修了 (推定)
2026年11月20日
研究の完了 (推定)
2026年12月15日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月15日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22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15日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。