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Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in COPD

27 de outubro de 2022 atualizado por: Ceyhun Topcuoğlu, Abant Izzet Baysal University

Investigation of Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in Individuals With COPD

In the literature, it has been observed that there is an increase in respiratory muscle activity in individuals with COPD due to the increase in respiratory workload and in response to the loads given by respiratory muscle training devices. However, no study has been found in the literature comparing the activation of respiratory muscles during constant threshold load endurance test and increasing threshold load endurance test performed with respiratory muscle training devices, which are important for respiratory muscle function evaluation. With this planned study, it is aimed to contribute to the literature by examining the changes in muscle activation during the constant threshold load and increasing threshold load endurance tests where different workloads are given and by comparing these changes.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality that is affected by many factors that cause abnormal lung development resulting from exposure to harmful gases or particles. COPD is known as the fourth most common cause of death in the world and is expected to rise to third place by the end of 2020. Physiopathological changes such as airflow limitation, bronchial fibrosis, increased airway resistance, ciliary dysfunction, gas exchange abnormalities and air trapping occur in COPD. While smoking is the most common risk factor in COPD; Occupational dust and chemicals, air pollution, lung growth and development, genetic predisposition such as age and gender, and exposure to environmental effects. Symptoms such as shortness of breath (dyspnea), cough, and sputum are common in COPD. In addition to pulmonary changes such as an increase in respiratory workload in individuals with COPD, there are also extrapulmonary changes such as respiratory muscle dysfunction.

respiratory muscle dysfunction; It is a decrease in respiratory muscle strength, endurance, or both, resulting from factors such as elongated diaphragm fibers, increased respiratory workload, changes in muscle mass and abdominal weight. Strength is defined as the muscle's capacity to produce power, while endurance is defined as the muscle's ability to sustain a given force over time (the capacity to resist fatigue). Loss of strength and/or endurance contributes to diaphragm weakness and impaired performance. Today, respiratory muscle strength parameters (MIP, MEP) are widely used in the evaluation of respiratory muscle function. However, evaluation of respiratory muscle endurance is more effective than respiratory muscle strength in the evaluation of submaximal respiratory muscle contraction, which is valid for daily activities, and in the clinical, functional and prognostic evaluation of respiratory muscles. Respiratory muscle endurance can be measured with constant threshold load and increased threshold load endurance tests. The imbalance between the function of the respiratory muscles and the respiratory workload they face chronically plays an important role in the formation of dyspnea and hypercapnia. Neural respiratory impulse (NRD), which is indirectly measured by electromyogram (EMG) of respiratory muscles, has attracted attention as a potential physiological marker indicating clinical deterioration due to imbalance between workload and capacity of respiratory muscles. The neural respiratory drive (NRD) is the output of the brainstem respiratory centers. NRD is not affected by the patient's will, is associated with symptoms such as dyspnea, and is usually increased in COPD.

Mechanical abnormalities such as airflow obstruction, static and dynamic hyperinflation, and intrinsic positive end-expiratory pressure increase the load on respiratory muscles in individuals with COPD. Inspiratory muscle contraction is impaired as a result of pressure changes, muscle shortening, increased contraction rate, change in geometry, and decreased compliance of the respiratory system. As a result, an increase in muscle activation and NRD is observed. Those with severe COPD require significantly higher muscle activations, both electrical and mechanical, to breathe and overcome the respiratory workload than those with mild to moderate COPD. In individuals with COPD, NRD increases when the load on the respiratory muscles increases as a result of an increase in respiratory workload, a decrease in capacity, or a combination of both. Studies have shown that, in addition to respiratory workload, workloads given with respiratory muscle training devices lead to an increase in the activation of respiratory muscles.

In the literature, it has been observed that there is an increase in respiratory muscle activity in individuals with COPD due to the increase in respiratory workload and in response to the loads given by respiratory muscle training devices. However, no study has been found in the literature comparing the activation of respiratory muscles during constant threshold load endurance test and increasing threshold load endurance test performed with respiratory muscle training devices, which are important for respiratory muscle function evaluation. With this planned study, it is aimed to contribute to the literature by examining the changes in muscle activation during the constant threshold load and increasing threshold load endurance tests where different workloads are given and by comparing these changes.

Tipo de estudo

Observacional

Inscrição (Antecipado)

21

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

40 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.

Descrição

Inclusion Criteria:

  • Individuals diagnosed with chronic obstructive pulmonary disease
  • Be between the ages of 40-65
  • No medication changes due to acute exacerbation for at least three weeks
  • Be stable
  • Volunteering to participate in research
  • To cooperate
  • Patients with written consent form
  • Healthy individuals in a similar age range without a diagnosed disease and symptoms will be included

Exclusion Criteria:

  • Those with a history of chronic obstructive pulmonary disease exacerbations
  • Individuals with orthopedic disease
  • Individuals with neurological disease
  • Individuals with other co-existing lung and systemic diseases other than chronic obstructive pulmonary disease
  • Those who have had major surgery in the past few months
  • Individuals with a history of recurrent significant clinical infections
  • Have cognitive problems
  • Having had unstable angina,
  • Previous Myocardial Infarction
  • Individuals with severe congestive heart failure refractory to medical therapy, individuals with uncontrolled hypertension
  • Individuals with cancer

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
Observational Group
Individuals who were diagnosed with COPD by Bolu Abant İzzet Baysal University Medical Faculty Chest Diseases Department and referred to Bolu Abant İzzet Baysal University Health Sciences Faculty Physiotherapy and Rehabilitation Department will be included in the study.
Respiratory muscle electromyographic activations of individuals will be evaluated during the test while breathing rapidly and deeply from the beginning of the constant threshold load endurance test and the increasing threshold load endurance test until the end of the test, and at rest. Respiratory muscle endurance will be evaluated with constant threshold load endurance test and increasing threshold load endurance test, respiratory functions with pulmonary function test, respiratory muscle strength with intraoral pressure measurement device, health condition disorder with Chronic Obstructive Pulmonary Disease Assessment Scale, dyspnea with Modified Medical Research Council Dyspnea Scale and Modified Borg Scale. Participants' names, anthropometric measurements, demographic data, contact information and medical history will be collected and recorded with the patient anamnesis form.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Eletromiografia de Superfície
Prazo: 45 minutos
A ativação dos músculos respiratórios será realizada com um aparelho de Eletromiografia (EMG) de superfície. A medição será realizada colocando eletrodos de Eletromiografia (EMG) nos pontos motores dos músculos respiratórios. O aumento das ativações dos músculos respiratórios indica que os músculos respiratórios são mais usados; A diminuição das ativações dos músculos respiratórios indica que os músculos respiratórios são menos utilizados.
45 minutos

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Medição da Pressão Inspiratória Máxima
Prazo: 5 minutos
A Pressão Inspiratória Máxima será medida com um dispositivo de medição de pressão intraoral. A Pressão Inspiratória Máxima reflete a força muscular respiratória. Um aumento na pressão inspiratória máxima indica alta força muscular respiratória; Um valor baixo de pressão inspiratória máxima indica fraqueza muscular respiratória.
5 minutos
Teste de Resistência de Carga Limite Incremental
Prazo: 10 minutos
A resistência muscular respiratória será medida com um teste de resistência muscular respiratória de carga limiar incremental. O teste de resistência muscular respiratória será realizado utilizando um aparelho de treinamento muscular respiratório. O teste de resistência é realizado respirando rápida e profundamente contra o dispositivo de treinamento muscular respiratório do indivíduo. O indivíduo deve continuar o teste o maior tempo possível. Um alto escore de resistência dos músculos respiratórios indica boa função dos músculos respiratórios; Uma pontuação baixa indica disfunção muscular respiratória.
10 minutos
Sustained Threshold Load Endurance Test
Prazo: 10 minutes
Respiratory muscle endurance will be measured with an sustained threshold load respiratory muscle endurance test. The respiratory muscle endurance test will be performed using a respiratory muscle training device. Endurance test is performed by breathing rapidly and deeply against the respiratory muscle training device of the individual. The individual should continue the test as long as possible. A high respiratory muscle endurance score indicates good respiratory muscle function; A low score indicates respiratory muscle dysfunction.
10 minutes
Pulmonary Function Test:
Prazo: 5 minutes
Pulmonary function test will be performed with a spirometer according to the criteria of the American Thoracic Society and the European Respiratory Society. While the decrease in pulmonary function test parameters shows worsening of lung functions; parameters in the normal range indicate good lung functions.
5 minutes
Chronic Obstructive Pulmonary Disease Assessment Test
Prazo: 2 minutes
Chronic Obstructive Pulmonary Disease Assessment Test is an eight-item scale measuring health status in Chronic Obstructive Pulmonary Disease. This scale is used to determine the health status of individuals with Chronic Obstructive Pulmonary Disease all over the world. Each question is scored between 0-5 and a total score between 0 and 40 is given. A score of 0 represents the best and a score of 40 represents the worst state of health.
2 minutes
Modified Medical Research Council Dyspnea Scale
Prazo: 2 minutes
It is a 5-item scale scored between 0-4 for individuals' shortness of breath. Evaluates dyspnea and activity limitation in individuals with COPD
2 minutes
Modified Borg Scale (MBS) Çeviri sonuçları Modified Borg Scale (MBS):
Prazo: 2 minutes
It is a 5-item scale scored between 0-4 for individuals' shortness of breath. Evaluates dyspnea and activity limitation in individuals with chronic obstructive pulmonary disease. An increase in the score indicates an increase in shortness of breath.
2 minutes

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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 (Antecipado)

25 de junho de 2023

Conclusão Primária (Antecipado)

25 de julho de 2023

Conclusão do estudo (Antecipado)

25 de agosto de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

9 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de julho de 2021

Primeira postagem (Real)

30 de julho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de outubro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de outubro de 2022

Última verificação

1 de outubro de 2022

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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