- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04983485
Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in COPD
Investigation of Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in Individuals With COPD
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Povrchová elektromyografie
Časové okno: 45 minut
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Aktivace dýchacích svalů bude prováděna pomocí přístroje povrchové elektromyografie (EMG).
Měření bude prováděno umístěním elektromyografických (EMG) elektrod na motorické body dýchacích svalů.
Zvýšená aktivace dýchacích svalů naznačuje, že dýchací svaly jsou více využívány; Pokles aktivace dýchacích svalů ukazuje, že dýchací svaly jsou méně využívány.
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45 minut
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Měření maximálního inspiračního tlaku
Časové okno: 5 minut
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Maximální inspirační tlak bude měřen pomocí zařízení na měření intraorálního tlaku.
Maximální inspirační tlak odráží sílu dýchacích svalů.
Zvýšení maximálního inspiračního tlaku indikuje vysokou sílu dýchacích svalů; Nízká hodnota maximálního inspiračního tlaku indikuje slabost dýchacích svalů.
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5 minut
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Test odolnosti přírůstkové prahové zátěže
Časové okno: 10 minut
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Odolnost dýchacích svalů bude měřena testem odolnosti dýchacích svalů s přírůstkovou prahovou zátěží.
Zkouška odolnosti dýchacích svalů bude provedena pomocí zařízení pro trénink dýchacích svalů.
Vytrvalostní test se provádí rychlým a hlubokým dýcháním proti zařízení pro trénink dýchacích svalů jedince.
Jedinec by měl pokračovat v testu tak dlouho, jak je to možné.
Vysoké skóre vytrvalosti dýchacích svalů ukazuje na dobrou funkci dýchacích svalů; Nízké skóre ukazuje na dysfunkci dýchacích svalů.
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10 minut
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Sustained Threshold Load Endurance Test
Časové okno: 10 minutes
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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.
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10 minutes
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Pulmonary Function Test:
Časové okno: 5 minutes
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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.
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5 minutes
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Chronic Obstructive Pulmonary Disease Assessment Test
Časové okno: 2 minutes
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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.
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2 minutes
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Modified Medical Research Council Dyspnea Scale
Časové okno: 2 minutes
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It is a 5-item scale scored between 0-4 for individuals' shortness of breath.
Evaluates dyspnea and activity limitation in individuals with COPD
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2 minutes
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Modified Borg Scale (MBS) Çeviri sonuçları Modified Borg Scale (MBS):
Časové okno: 2 minutes
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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.
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2 minutes
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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Klinické studie na Observational
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