Chronic Obstructive Pulmonary DiseaseNCT04974788
Examination of Acute Effects of Different Intensity Respiratory Muscle Training on Respiratory Muscle Activations
A study testing Low Intensity Respiratory Muscle Training, Medium Intensity Respiratory Muscle Training and High Intensity Respiratory Muscle Training in people with Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University.
Trial summary
It has been observed in the literature that respiratory muscle electromyography activations at certain threshold loads have been examined in individuals with chronic obstructive pulmonary disease. 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?
- Low Intensity Respiratory Muscle Training, Medium Intensity Respiratory Muscle Training and High Intensity Respiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 30 Aug 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with chronic obstructive pulmonary disease
- Be between the ages of 40-75
- 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.
About this study
It has been observed in the literature that respiratory muscle electromyography activations at certain threshold loads have been examined in individuals with chronic obstructive pulmonary disease. However, no study has been found in the literature examining the acute effects of respiratory muscle training given at low, medium and high threshold loads on respiratory muscle activations. With this planned study, it is aimed to examine the electromyography activations of respiratory muscles before and after respiratory muscle training and to contribute to the literature by comparing the acute effects of respiratory muscle training applied at low, medium and high intensity on respiratory muscle electromyography activations.
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. In addition to pulmonary changes such as increased respiratory workload, there are also extrapulmonary changes such as respiratory muscle dysfunction in individuals with chronic obstructive pulmonary disease.
Respiratory muscle dysfunction; It is a decrease in respiratory muscle strength, endurance, or both, caused by 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.
Neural respiratory impulse, indirectly measured by electromyogram of respiratory muscles, has attracted attention as a potential physiological marker of clinical deterioration due to imbalance between workload and capacity of respiratory muscles. The neural respiratory drive is the output of the brainstem respiratory centers. Neural respiratory drive is not affected by the patient's will, is associated with symptoms such as dyspnea, and is usually increased in chronic obstructive pulmonary disease patients.
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 chronic obstructive pulmonary disease. 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 neural respiratory drive is observed. Those with severe chronic obstructive pulmonary disease require significantly higher muscle activations, both electrical and mechanical, to breathe and overcome the respiratory workload than those with mild to moderate chronic obstructive pulmonary disease. In individuals with chronic obstructive pulmonary disease, neural respiratory drive 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 addition to pulmonary changes, extrapulmonary changes occur in individuals with chronic obstructive pulmonary disease. Loss of respiratory muscle strength and endurance; The effect of the inappropriate position of the diaphragm on length-tension due to hyperinflation are among the most common extrapulmonary changes resulting from the use of corticosteroids, hypoxemia and hypercapnia. Weakness of respiratory muscles in chronic obstructive pulmonary disease patients leads to hypoxemia, hypercapnia, dyspnea and reduces exercise capacity. Inspiratory muscle training reduces type 2 fibers, shortens the inspiratory time, prolongs the expiratory time, and reduces dynamic hyperinflation. Inspiratory muscle training has been proposed as one of the non-pharmacological treatment modalities because it can delay worsening of lung function by increasing inspiratory muscle strength and endurance. In chronic obstructive pulmonary disease, inspiratory muscle training improves respiratory muscle strength and exercise capacity and reduces dyspnea and is widely used in therapy.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Low Intensity Respiratory Muscle Training, Medium Intensity Respiratory Muscle Training, High Intensity Respiratory Muscle Training
- Keywords
- Chronic Obstructive Pulmonary Disease, Surface EMG, Ventilation, Respiratory Muscle Training
- 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.
Low Intensity Respiratory Muscle TrainingOther
Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
Medium Intensity Respiratory Muscle TrainingOther
Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
High Intensity Respiratory Muscle TrainingOther
Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Respiratory Muscle Training Group | Active comparator | Low intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. Receives: Other: Low Intensity Respiratory Muscle Training |
| Medium Intensity Respiratory Muscle Training Group | Active comparator | Medium intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. Receives: Other: Medium Intensity Respiratory Muscle Training |
| High Intensity Respiratory Muscle Training Group | Active comparator | High intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. Receives: Other: High Intensity Respiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electromyography (EMG)
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 (5)
Pulmonary Function Test
Pulmonary function test will be performed with a spirometer according to the criteria of the American Thoracic Society (ATS) 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: 10 minutes
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
Chronic Obstructive Pulmonary Disease Assessment Test (CAT):
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
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
Modified Borg Scale (MBS):
In this scale, in which the perception of shortness of breath at rest and during exercise will be evaluated, scoring varies between 0-10 points, although high scores indicate high breathlessness and fatigue.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start30 Jun 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with a conventional therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Topcuoğlu, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974788
- Sponsor's protocol ID
- AIBU-FTR-CT-03
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Acute Effects of Different Intensity Respiratory Muscle Training on Respiratory Muscle Activations
- ClinicalTrials.gov ID
- NCT04974788
- Acronym / sponsor ID
- AIBU-FTR-CT-03
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Surface EMG, Ventilation, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been observed in the literature that respiratory muscle electromyography activations at certain threshold loads have been examined in individuals with chronic obstructive pulmonary disease. However, no study has been found in the literature examining the acute effects of respiratory muscle training given at low, medium and high threshold loads on respiratory muscle activations. With this planned study, it is aimed to examine the electromyography activations of respiratory muscles before and after respiratory muscle training and to contribute to the literature by comparing the acute effects of respiratory muscle training applied at low, medium and high intensity on respiratory muscle electromyography activations.
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. In addition to pulmonary changes such as increased respiratory workload, there are also extrapulmonary changes such as respiratory muscle dysfunction in individuals with chronic obstructive pulmonary disease.
Respiratory muscle dysfunction; It is a decrease in respiratory muscle strength, endurance, or both, caused by 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.
Neural respiratory impulse, indirectly measured by electromyogram of respiratory muscles, has attracted attention as a potential physiological marker of clinical deterioration due to imbalance between workload and capacity of respiratory muscles. The neural respiratory drive is the output of the brainstem respiratory centers. Neural respiratory drive is not affected by the patient's will, is associated with symptoms such as dyspnea, and is usually increased in chronic obstructive pulmonary disease patients.
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 chronic obstructive pulmonary disease. 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 neural respiratory drive is observed. Those with severe chronic obstructive pulmonary disease require significantly higher muscle activations, both electrical and mechanical, to breathe and overcome the respiratory workload than those with mild to moderate chronic obstructive pulmonary disease. In individuals with chronic obstructive pulmonary disease, neural respiratory drive 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 addition to pulmonary changes, extrapulmonary changes occur in individuals with chronic obstructive pulmonary disease. Loss of respiratory muscle strength and endurance; The effect of the inappropriate position of the diaphragm on length-tension due to hyperinflation are among the most common extrapulmonary changes resulting from the use of corticosteroids, hypoxemia and hypercapnia. Weakness of respiratory muscles in chronic obstructive pulmonary disease patients leads to hypoxemia, hypercapnia, dyspnea and reduces exercise capacity. Inspiratory muscle training reduces type 2 fibers, shortens the inspiratory time, prolongs the expiratory time, and reduces dynamic hyperinflation. Inspiratory muscle training has been proposed as one of the non-pharmacological treatment modalities because it can delay worsening of lung function by increasing inspiratory muscle strength and endurance. In chronic obstructive pulmonary disease, inspiratory muscle training improves respiratory muscle strength and exercise capacity and reduces dyspnea and is widely used in therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups with a conventional therapy
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Respiratory Muscle Training Group | Active comparator | Other: Low Intensity Respiratory Muscle TrainingLow intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. |
| Medium Intensity Respiratory Muscle Training Group | Active comparator | Other: Medium Intensity Respiratory Muscle TrainingMedium intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. |
| High Intensity Respiratory Muscle Training Group | Active comparator | Other: High Intensity Respiratory Muscle TrainingHigh intensity respiratory muscle training will be applied to those with chronic obstructive pulmonary disease. Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals diagnosed with chronic obstructive pulmonary disease
- Be between the ages of 40-75
- No medication changes due to acute exacerbation for at least three weeks
- Be stable
- Volunteering to participate in research
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Intensity Respiratory Muscle TrainingRespiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions. | Other | Low Intensity Respiratory Muscle Training Group |
| Medium Intensity Respiratory Muscle TrainingRespiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions. | Other | Medium Intensity Respiratory Muscle Training Group |
| High Intensity Respiratory Muscle TrainingRespiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions. | Other | High Intensity Respiratory Muscle Training Group |
Primary outcome
Surface Electromyography (EMG)
Time frame: 45 minutes
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.
5 secondary outcomes
Pulmonary Function Test
Time frame: 10 minutes
Measurement of Maximal Inspiratory Pressure
Time frame: 5 minutes
Chronic Obstructive Pulmonary Disease Assessment Test (CAT):
Time frame: 5 minutes
Modified Medical Research Council Dyspnea Scale:
Time frame: 2 minutes
Modified Borg Scale (MBS):
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Respiratory Muscle Training, Medium Intensity Respiratory Muscle Training and High Intensity Respiratory Muscle Training in people with 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 (EMG) (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.