Respiratory and Exercise Responses by Body Roundness Index in Obesity
12 de maio de 2026 atualizado 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.
Visão geral do estudo
Tipo de estudo
Observacional
Inscrição (Estimado)
120
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Buket Akinci, Prof. Dr.
- Número de telefone: +90 505 641 56 92
- E-mail: bakinci@biruni.edu.tr
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Individuals with obesity
|
Participants will not receive any therapeutic or experimental intervention; only observational and functional assessments will be performed.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Forced vital capacity (FVC)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Exercise capacity
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: Day 1
|
Peak ventilation (VEpeak) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Peak breathing reserve (BRpeak)
Prazo: Day 1
|
Peak breathing reserve (BRpeak) (Unit of Measure: %) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Inspiratory capacity (IC)
Prazo: Day 1
|
Inspiratory capacity (IC) during the 6MWT will be assessed using the Spiropalm device.
|
Day 1
|
|
Body muscle mass (kg)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
20 de junho de 2026
Conclusão Primária (Estimado)
20 de novembro de 2026
Conclusão do estudo (Estimado)
9 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de maio de 2026
Primeira postagem (Real)
19 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Excesso de peso
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Obesidade
- Administração de Serviços de Saúde
- Qualidade de assistência médica
- Avaliação de resultados, assistência médica
- Avaliação de resultados e processos, assistência médica
- Esperando vigilante
Outros números de identificação do estudo
- Obesity1052026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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