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Chronic Obstructive Pulmonary DiseaseNCT04983472

Comparison of Respiratory Muscle Activations During Dyspnea Reduction Positions in Individuals

An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Chronic and progressive dyspnea is the most characteristic symptom of chronic obstructive pulmonary disease. There are studies in the literature showing that electromyography activations of respiratory muscles increase in individuals with chronic obstructive pulmonary disease and that the severity of the perceived… Read more about this study

Who is it for?
Ages 40 to 75 years, men only
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Observational
How many people
19 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jul 2021to 20 May 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
  • Men only
  • 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

1 site in 1 country.

Eylem TÜTÜN YÜMİN, Assoc Prof. contact

05056763191

eylemtutun78@hotmail.com

Ceyhun TOPCUOĞLU, Res. Assist. contact

05356535137

ceyhuntopcuoglu1@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation

    Bolu

    Eylem TÜTÜN YÜMİN, Assoc. Prof., +90 505 676 31 91, eylemtutun78@hotmail.com

    Ceyhun TOPCUOĞLU, Res. Assist., +90 535 653 51 37, ceyhuntopcuoglu1@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Respiratory Muscle Activations During Dyspnea Reduction Positions in Individuals With Chronic Obstructive Pulmonary Disease

Chronic and progressive dyspnea is the most characteristic symptom of chronic obstructive pulmonary disease. There are studies in the literature showing that electromyography activations of respiratory muscles increase in individuals with chronic obstructive pulmonary disease and that the severity of the perceived shortness of breath is associated with muscle activation. However, no study has been found comparing respiratory muscle activations during pursed lip breathing and normal breathing in the dyspnea reduction positions and supine position used in the treatment and management of chronic obstructive pulmonary disease. The aim of this study is to evaluate the effects of different dyspnea reduction positions on respiratory muscle activations separately, to compare respiratory muscle activation during normal breathing, respiratory control and pursed lip breathing during these different positions, and to classify muscle activations according to the severity of chronic obstructive pulmonary disease.

Read the detailed description

Chronic obstructive pulmonary disease is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality, which is affected by many factors that cause abnormal lung development resulting from exposure to harmful gases or particles. Chronic obstructive pulmonary disease 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 chronic obstructive pulmonary disease. While smoking is the most common risk factor in chronic obstructive pulmonary disease; 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 chronic obstructive pulmonary disease.

Chronic and progressive dyspnea is the most characteristic symptom of chronic obstructive pulmonary disease. About 30% of individuals with chronic obstructive pulmonary disease have a productive cough. These symptoms can vary from day to day and may precede airflow limitation for years. Significant airflow limitation may also be present without chronic dyspnea, cough, and sputum production. Although chronic obstructive pulmonary disease is defined based on air restriction, individuals with chronic obstructive pulmonary disease usually make the decision to seek treatment based on the effect of symptoms on functional status. Dyspnea, which is the main symptom of chronic obstructive pulmonary disease, is the main cause of disability and anxiety associated with the disease. Typical chronic obstructive pulmonary disease patients define dyspnea as a feeling of increased breathing effort, heaviness in the chest, and air hunger.

Today, it has been shown that there are many underlying causes of dyspnea. In chronic obstructive pulmonary disease patients, minute ventilation and dead space ventilation due to increased workload increase respiratory motor output in association with an increase in carbon dioxide production. As a result, individuals feel short of breath. Simple mechanical distention of the airways during exhalation, which is defined as dynamic airway compression, is another cause of dyspnea in patients with chronic obstructive pulmonary disease. Different positions and breathing patterns affect the perception of dyspnea in individuals with chronic obstructive pulmonary disease. In current studies, individuals with chronic obstructive pulmonary disease have an increased perception of shortness of breath in the supine position (orthopnea); It was observed that the perception of shortness of breath decreased in pursed lib (pursed lip) breathing and dyspnea reduction positions. Therefore, pursed lip breathing and breathlessness reduction positions are frequently used in the treatment of individuals with chronic obstructive pulmonary disease. Leaning forward, comfortable sitting, leaning forward, standing with the back leaning, high side lying are the most commonly used positions to reduce dyspnea.

It has been shown that the forward bending position, one of the dyspnea-reducing positions, improves the length-tension relationship and function of the diaphragm muscle, decreases the activity of the sternocleidomastoideus, scalene muscles, improves thoracoabdominal movement, and helps to reduce shortness of breath. Pursed-lip breathing, on the other hand, increases tidal volume, leading to increased rib cage movement and accessory muscle recruitment during inspiration and expiration.

Compared to healthy individuals, individuals with chronic obstructive pulmonary disease have an increased electromyographic activation of respiratory muscles. In chronic obstructive pulmonary disease patients, there is an increase in respiratory muscle activation and shortness of breath due to the imbalance between the workload and capacity of the respiratory muscles. In current studies, it has been observed that the severity of dyspnea perception and respiratory muscle activations are related.

There are studies in the literature showing that electromyographic activations of respiratory muscles increase in individuals with chronic obstructive pulmonary disease and that the severity of the perceived shortness of breath is associated with muscle activation. However, no study has been found comparing respiratory muscle activations during pursed lip breathing and normal breathing in dyspnea reduction positions and supine position used in the treatment and management of chronic obstructive pulmonary disease. The aim of this study is to evaluate the effects of different dyspnea reduction positions on respiratory muscle activations separately, to compare respiratory muscle activation during normal breathing, respiratory control and pursed lip breathing during these different positions, and to classify muscle activations according to the severity of chronic obstructive pulmonary disease.

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

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 taken during supine, normal sitting and dyspnea reduction positions. Individuals with chronic obstructive pulmonary disease will be asked to perform normal breathing, pursed lip breathing, and breathing control during these positions. Respiratory muscle activation measurement of individuals will be taken during different breathing patterns in each position. Respiratory functions will be evaluated with pulmonary function test, respiratory muscle strength, intraoral pressure measurement device, respiratory muscle activation with surface electromyographic device, health status 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 NCT04983472
Study groupRoleWhat they receive
Observational GroupIndividuals diagnosed with Chronic Obstructive Pulmonary Disease by the Department of Pulmonology of the Faculty of Medicine of Bolu Abant Izzet Baysal University will be referred to the Department of Physiotherapy and rehabilitation of the Faculty of Health Sciences of Bolu Abant Izzet Baysal University
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 (4)
  1. 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

  2. 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

  3. 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: 5 minutes

  4. 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 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 start20 Jul 2021
  3. Primary completion20 Jan 2023
  4. Study completion20 May 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
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983472
Sponsor's protocol ID
AIBU-FTR-CT-01
Status last verified
Mar 2023
First submitted
9 Jul 2021
Last updated
29 Mar 2023
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 at 1 site in Turkey (Türkiye).

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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 29 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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