Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern
15. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Pozorovací
Zápis (Odhadovaný)
100
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Buket Akinci, Prof. Dr.
- Telefonní číslo: +90 505 6415692
- E-mail: bakinci@biruni.edu.tr
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Obese Individuals with Restrictive Ventilatory Pattern
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Obese Individuals with Restrictive Ventilatory Pattern
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional capacity
Časové okno: 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.
|
Day 1
|
|
Respiratory Muscle Endurance
Časové okno: 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.
|
Day 1
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body fat mass
Časové okno: 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.
|
Day 1
|
|
Forced vital capacity (FVC)
Časové okno: 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.
|
Day 1
|
|
Ventilation (VE)
Časové okno: Day 1
|
Ventilation (VE) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle mass
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: Day 1
|
Peak ventilation (VEpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Peak breathing reserve (BRpeak)
Časové okno: Day 1
|
Peak breathing reserve (BRpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Respiratory frequency (RF)
Časové okno: Day 1
|
Respiratory frequency (RF) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
Časové okno: Day 1
|
Inspiratory capacity (IC) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle percentage
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
30. června 2026
Primární dokončení (Odhadovaný)
20. listopadu 2026
Dokončení studie (Odhadovaný)
15. prosince 2026
Termíny zápisu do studia
První předloženo
8. května 2026
První předloženo, které splnilo kritéria kontroly kvality
15. května 2026
První zveřejněno (Aktuální)
22. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Obesity2052026
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