Body Composition, Functional Capacity, and Respiratory Muscle Endurance in Obesity With Restrictive Ventilatory Pattern
15 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Buket Akinci, Prof. Dr.
- Número de teléfono: +90 505 6415692
- Correo electrónico: bakinci@biruni.edu.tr
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Obese Individuals with Restrictive Ventilatory Pattern
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional capacity
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body fat mass
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Day 1
|
Ventilation (VE) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle mass
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Day 1
|
Respiratory frequency (RF) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
Periodo de tiempo: Day 1
|
Inspiratory capacity (IC) will be measured during the Six-Minute Walk Test (6MWT) using the Spiropalm device.
|
Day 1
|
|
Body muscle percentage
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de junio de 2026
Finalización primaria (Estimado)
20 de noviembre de 2026
Finalización del estudio (Estimado)
15 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Obesity2052026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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