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Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern

15 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Obese Individuals with Restrictive Ventilatory Pattern

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Obese Individuals with Restrictive Ventilatory Pattern
Autre: Pulmonary Function, Body Composition, and Functional Capacity Assessment
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Functional capacity
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Body fat mass
Délai: 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)
Délai: 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)
Délai: Day 1
Ventilation (VE) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
Day 1
Body muscle mass
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Day 1
Respiratory frequency (RF) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
Day 1
Inspiratory capacity (IC)
Délai: Day 1
Inspiratory capacity (IC) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
Day 1
Body muscle percentage
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biruni University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 juin 2026

Achèvement primaire (Estimé)

20 novembre 2026

Achèvement de l'étude (Estimé)

15 décembre 2026

Dates d'inscription aux études

Première soumission

8 mai 2026

Première soumission répondant aux critères de contrôle qualité

15 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Obesity2052026

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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