Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restricti… (NCT07601555) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern
100 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
25 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.