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

NCT07601555 | Not Yet Recruiting

• 1 other identifier: Obesity2052026
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Functional capacity

  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

  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

Secondary Outcomes (12)

• Body fat mass

  Day 1

• Forced vital capacity (FVC)

  Day 1

• Ventilation (VE)

  Day 1

• Body muscle mass

  Day 1

• Forced expiratory volume in the first second (FEV1)

  Day 1

Study Arms (1)

Obese Individuals with Restrictive Ventilatory Pattern

Other: Pulmonary Function, Body Composition, and Functional Capacity Assessment

Interventions

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.

Obese Individuals with Restrictive Ventilatory Pattern

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Obese Individuals with Restrictive Ventilatory Pattern

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

MeSH Terms

Conditions

Obesity

Interventions

Body Composition

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Central Study Contacts

Buket Akinci, Prof. Dr.

CONTACT

+90 505 6415692; bakinci@biruni.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05