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Not yet recruiting NCT07601555

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

— Observational Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary Function, Body Composition, and Functional Capacity Assessment.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigation of the Relationship Between Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Individuals With Obesity and a Restrictive Ventilatory Pattern

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Functional capacity [Time frame: Day 1]
  • Respiratory Muscle Endurance [Time frame: Day 1]
Secondary outcome measures (12)
  • Body fat mass [Time frame: Day 1]
  • Forced vital capacity (FVC) [Time frame: Day 1]
  • Ventilation (VE) [Time frame: Day 1]
  • Body muscle mass [Time frame: Day 1]
  • Forced expiratory volume in the first second (FEV1) [Time frame: Day 1]
  • FEV1/FVC ratio [Time frame: Day 1]
  • Peak ventilation (VEpeak) [Time frame: Day 1]
  • Peak breathing reserve (BRpeak) [Time frame: Day 1]
  • Respiratory frequency (RF) [Time frame: Day 1]
  • Inspiratory capacity (IC) [Time frame: Day 1]
  • Body muscle percentage [Time frame: Day 1]
  • Weight-Adjusted Waist Index (WWI) [Time frame: Day 1]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07601555 · Obesity2052026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗