Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern
15. maj 2026 opdateret af: Buket AKINCI, Biruni University
Investigation of the Relationship Between Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Individuals With Obesity and a Restrictive Ventilatory Pattern
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Buket Akinci, Prof. Dr.
- Telefonnummer: +90 505 6415692
- E-mail: bakinci@biruni.edu.tr
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Obese Individuals with Restrictive Ventilatory Pattern
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Obese Individuals with Restrictive Ventilatory Pattern
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional capacity
Tidsramme: Day 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.
|
Day 1
|
|
Respiratory Muscle Endurance
Tidsramme: Day 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 their mouth and terminate the test at any time in the event of any discomfort or adverse symptoms.
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body fat mass
Tidsramme: Day 1
|
Participants' body fat mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Participants will be informed about the test protocol and instructed to fast for 8-12 hours before the assessment, arrive with an empty bladder, and avoid fluid intake, food consumption, and vigorous physical activity prior to testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Forced vital capacity (FVC)
Tidsramme: Day 1
|
Forced vital capacity (FVC) will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded.
|
Day 1
|
|
Ventilation (VE)
Tidsramme: Day 1
|
Ventilation (VE) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle mass
Tidsramme: Day 1
|
Body muscle mass (kg) will be measured using Bioelectrical Impedance Analysis (BIA).
Participants will be informed about the test protocol and instructed to fast for 8-12 hours before the assessment, arrive with an empty bladder, and avoid fluid intake, food consumption, and vigorous physical activity prior to testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Forced expiratory volume in the first second (FEV1)
Tidsramme: Day 1
|
Forced expiratory volume in the first second (FEV1) will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded.
|
Day 1
|
|
FEV1/FVC ratio
Tidsramme: Day 1
|
FEV1/FVC ratio will be evaluated using a Pulmonary Function Test (PFT) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria, utilizing the "COSMED Spiropalm 6MWT" device (COSMED, Italy) and its integrated PFT software (ATS & ERS, 2002).
Assessments will be performed in a seated position with back support.
To minimize the risk of infection, a disposable mouthpiece and filter will be used for each participant.
Values will be recorded both in liters and as percentages (%) of predicted values.
Measurements will be repeated three times, and the best value meeting the measurement standards will be recorded
|
Day 1
|
|
Peak ventilation (VEpeak)
Tidsramme: Day 1
|
Peak ventilation (VEpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Peak breathing reserve (BRpeak)
Tidsramme: Day 1
|
Peak breathing reserve (BRpeak) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Respiratory frequency (RF)
Tidsramme: Day 1
|
Respiratory frequency (RF) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
Tidsramme: Day 1
|
Inspiratory capacity (IC) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle percentage
Tidsramme: Day 1
|
Body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Participants will be informed about the test protocol and instructed to fast for 8-12 hours before the assessment, arrive with an empty bladder, and avoid fluid intake, food consumption, and vigorous physical activity prior to testing.
Measurements will be performed during daytime at a room temperature of 25°C.
Participants will be assessed while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Weight-Adjusted Waist Index (WWI)
Tidsramme: Day 1
|
Weight-Adjusted Waist Index (WWI) will be calculated by dividing waist circumference (cm) by the square root of body weight (kg).
|
Day 1
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juni 2026
Primær færdiggørelse (Anslået)
20. november 2026
Studieafslutning (Anslået)
15. december 2026
Datoer for studieregistrering
Først indsendt
8. maj 2026
Først indsendt, der opfyldte QC-kriterier
15. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Obesity2052026
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