Respiratory and Exercise Responses by Body Roundness Index in Obesity
12 de mayo de 2026 actualizado por: Buket AKINCI, Biruni University
Evaluation of Respiratory Performance and Exercise Responses According to Body Roundness Index in Individuals With Obesity
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.
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Estimado)
120
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: +90 505 641 56 92
- 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
The study population will consist of adults with obesity between 25 and 60 years of age with a body mass index (BMI) ≥ 30 kg/m² according to the World Health Organization classification.
Participants will be recruited on a voluntary basis and will undergo anthropometric, respiratory, and exercise capacity assessments.
Descripción
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
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 |
|---|---|
|
Individuals with obesity
|
Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Forced vital capacity (FVC)
Periodo de tiempo: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
Forced vital capacity (FVC) will be measured.
Values will be recorded in liter and as percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
Maximum Inspiratory Pressure (MIP)
Periodo de tiempo: Day 1
|
Respiratory muscle strength assessment will be performed using an intraoral pressure measurement device (MicroRPM, Micro Medical, United Kingdom) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria (ATS/ERS, 2002).
Measurements will be conducted in a seated position while wearing a nose clip.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
For maximal inspiratory pressure (MIP) measurement, participants will perform a maximal inspiratory effort through the mouth for a few seconds.
Measurements will be repeated three times, and the best value meeting standardization criteria will be recorded in cmH₂O.
|
Day 1
|
|
Forced Expiratory Volume in 1 second (FEV1)
Periodo de tiempo: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
FEV1 ratio will be measured.
Values will be recorded percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
FEV1/FVC ratio
Periodo de tiempo: Day 1
|
The assessment will be performed in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Assessments will be conducted in a seated position with back support.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
FEV1/FVC ratio will be measured.
Values will be recorded percentage (%) of predicted values.
Measurements will be repeated three times, and the best value meeting measurement standardization criteria will be recorded.
|
Day 1
|
|
Maximal expiratory pressure (MEP)
Periodo de tiempo: Day 1
|
Respiratory muscle strength assessment will be performed using an intraoral pressure measurement device (MicroRPM, Micro Medical, United Kingdom) in accordance with the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria (ATS/ERS, 2002).
Measurements will be conducted in a seated position while wearing a nose clip.
To prevent the risk of infection, disposable mouthpieces and filters will be used for each participant.
For maximal expiratory pressure (MEP) measurement, a maximal expiratory effort will be performed for a few seconds, and the values will be recorded.
Measurements will be repeated three times, and the best value meeting standardization criteria will be recorded in cmH₂O.
|
Day 1
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exercise capacity
Periodo de tiempo: Day 1
|
Exercise capacity will be evaluated using the Six-Minute Walk Test (6MWT) according to the American Thoracic Society (ATS) guidelines with the Spiropalm 6MWT device (COSMED, Italy) (ATS, 2002).
Before the test, participants will rest for at least 10 minutes, and baseline measurements including heart rate, blood pressure, oxygen saturation, dyspnea, and leg fatigue will be recorded.
The test will be performed in a 30-meter indoor corridor, and participants will be instructed to walk as fast as possible for six minutes.
Total walking distance will be recorded in meters.
Heart rate, oxygen saturation, dyspnea, and fatigue levels will be reassessed after the test.
|
Day 1
|
|
Ventilation (VE)
Periodo de tiempo: Day 1
|
Ventilation (Unit of Measure: L/min) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Body fat mass index (kg)
Periodo de tiempo: Day 1
|
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 the measurements.
Assessments will be performed during daytime at a room temperature of 25°C.
Participants will be measured while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
Day 1
|
|
Body Roundness Index
Periodo de tiempo: Day 1
|
Body Roundness Index (BRI) will be calculated using waist circumference and height measurements according to the standardized BRI formula.
The BRI is a continuous index with no fixed minimum or maximum value.
Higher BRI values indicate greater body roundness and higher adiposity (worse outcome).
|
Day 1
|
|
Peak ventilation (VEpeak)
Periodo de tiempo: Day 1
|
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Peak breathing reserve (BRpeak)
Periodo de tiempo: Day 1
|
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
Periodo de tiempo: Day 1
|
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Body muscle mass (kg)
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 the measurements.
Assessments will be performed during daytime at a room temperature of 25°C.
Participants will be measured while clothed and barefoot after removing their shoes, socks, and all metal accessories.
|
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)
20 de junio de 2026
Finalización primaria (Estimado)
20 de noviembre de 2026
Finalización del estudio (Estimado)
9 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de mayo de 2026
Publicado por primera vez (Actual)
19 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad
- Administración de Servicios de Salud
- Calidad de la atención médica
- Evaluación de resultados, atención médica
- Evaluación de resultados y procesos, atención médica
- Esperanza vigilante
Otros números de identificación del estudio
- Obesity1052026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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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