Menu
Not yet recruiting NCT07595822

Respiratory and Exercise Responses by Body Roundness Index in Obesity

— 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: Observational.
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 →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Respiratory Performance and Exercise Responses According to Body Roundness Index in Individuals With Obesity

Overview

This observational study aims to evaluate respiratory performance and exercise responses according to Body Roundness Index (BRI) in individuals with obesity. Participants will undergo anthropometric and body composition assessments, respiratory muscle strength testing, pulmonary function evaluation, and a six-minute walk test. Exercise-related ventilatory responses, dyspnea, fatigue perception, oxygen saturation, and heart rate responses will also be assessed. The study seeks to investigate the relationship between BRI and cardiopulmonary performance and to determine whether BRI may serve as a useful indicator of obesity-related functional limitations and exercise capacity.

Interventions

  • Other Observational
    Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.

Primary outcome measures

  • Forced vital capacity (FVC) [Time frame: Day 1]
  • Maximum Inspiratory Pressure (MIP) [Time frame: Day 1]
  • Forced Expiratory Volume in 1 second (FEV1) [Time frame: Day 1]
  • FEV1/FVC ratio [Time frame: Day 1]
  • Maximal expiratory pressure (MEP) [Time frame: Day 1]
Secondary outcome measures (8)
  • Exercise capacity [Time frame: Day 1]
  • Ventilation (VE) [Time frame: Day 1]
  • Body fat mass index (kg) [Time frame: Day 1]
  • Body Roundness Index [Time frame: Day 1]
  • Peak ventilation (VEpeak) [Time frame: Day 1]
  • Peak breathing reserve (BRpeak) [Time frame: Day 1]
  • Inspiratory capacity (IC) [Time frame: Day 1]
  • Body muscle mass (kg) [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Individuals between 25 and 60 years of age
  • Individuals with a body mass index (BMI) ≥ 30 kg/m² according to the World Health Organization (WHO) classification
  • 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 difficulties, orthopedic disorders, or neurological problems that may interfere with assessment procedures
  • Individuals with a history of lower extremity injury or surgery within the last six months
  • Individuals diagnosed with diabetes mellitus and presenting 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 reduction during the assessment period
  • Individuals who underwent 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: NCT07595822 · Obesity1052026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗