Clinical trial NCT04983485: Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in COPD
Official title: Investigation of Respiratory Muscle Activations During Stable Threshold Load and Increasing Threshold Load Endurance Tests in Individuals With COPD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Surface Electromyography
Ventilation
Respiratory Endurance Test
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surface Electromyography
timeFrame: 45 minutes
Secondary outcomes:
measure: Incremental Threshold Load Endurance Test
timeFrame: 10 minutes
measure: Sustained Threshold Load Endurance Test
timeFrame: 10 minutes
measure: Pulmonary Function Test:
timeFrame: 5 minutes
measure: Measurement of Maximal Inspiratory Pressure
timeFrame: 5 minutes
measure: Chronic Obstructive Pulmonary Disease Assessment Test
timeFrame: 2 minutes
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: 2 minutes
measure: Modified Borg Scale (MBS) Çeviri sonuçları Modified Borg Scale (MBS):
timeFrame: 2 minutes
Other outcomes:
Locations:
Study officials:
References: