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Chronic Obstructive Pulmonary DiseaseNCT04983485

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

An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Observational
How many people
21 participants
Where
No sites listed yet
Study dates
25 Jun 2023to 25 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Eylem TÜTÜN YÜMİN, Assoc Prof. contact

05056763191

eylemtutun78@hotmail.com

Ceyhun TOPCUOĞLU, Res. Assist. contact

05356535137

ceyhuntopcuoglu1@gmail.com

About this study

Official title: 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.

Read the 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.

Being tested
Observational
Keywords
Chronic Obstructive Pulmonary Disease, Surface Electromyography, Ventilation, Respiratory Endurance Test
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    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.

Study groups in NCT04983485
Study groupRoleWhat they receive
Observational GroupIndividuals 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.
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surface Electromyography

    Activation of respiratory muscles will be performed with a surface Electromyography (EMG) device. The measurement will be performed by placing Electromyography (EMG) electrodes on the motor points of the respiratory muscles. Increased respiratory muscle activations indicate that respiratory muscles are used more; The decrease in respiratory muscle activations indicates that the respiratory muscles are used less.

    Measured: 45 minutes

Secondary outcomes (7)
  1. Incremental Threshold Load Endurance Test

    Respiratory muscle endurance will be measured with an incremental 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.

    Measured: 10 minutes

  2. Sustained Threshold Load Endurance Test

    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.

    Measured: 10 minutes

  3. Pulmonary Function Test:

    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.

    Measured: 5 minutes

  4. Measurement of Maximal Inspiratory Pressure

    Maximal Inspiratory Pressure will be measured with an intraoral pressure measuring device. Maximal Inspiratory Pressure reflects respiratory muscle strength. An increase in Maximal Inspiratory Pressure indicates high respiratory muscle strength; A low Maximal Inspiratory Pressure value indicates respiratory muscle weakness.

    Measured: 5 minutes

  5. Chronic Obstructive Pulmonary Disease Assessment Test

    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.

    Measured: 2 minutes

  6. Modified Medical Research Council Dyspnea Scale

    It is a 5-item scale scored between 0-4 for individuals' shortness of breath. Evaluates dyspnea and activity limitation in individuals with COPD

    Measured: 2 minutes

  7. Modified Borg Scale (MBS) Çeviri sonuçları Modified Borg Scale (MBS):

    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.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start25 Jun 2023 (estimated)
  3. Primary completion25 Jul 2023 (estimated)
  4. Study completion25 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983485
Sponsor's protocol ID
AIBU-FTR-CT-02
Status last verified
Oct 2022
First submitted
9 Jul 2021
Last updated
28 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eylem TÜTÜN YÜMİN, Assoc Prof. (05056763191, eylemtutun78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surface Electromyography (time frame: 45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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