Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07601555

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

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

Treatments and study arms

Pulmonary Function, Body Composition, and Functional Capacity Assessment

Other

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.

Primary outcomes

Functional capacityDay 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.

Respiratory Muscle EnduranceDay 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 t…

Study locations

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No public site location was included in this record. Check the original registry for updates.