Chronic Obstructive Pulmonary DiseaseNCT03522376
Inspiratory Muscle Activation Patterns in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Loaded inspiratory muscle test
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2018to 20 Dec 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Recent studies show that other than respiratory symptoms, patients with chronic obstructive pulmonary disease often present with inspiratory muscle weakness.
Who may be able to join
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
- can cooperate with the measurements of this study
Who cannot join
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- participated in inspiratory muscle training program in the previous three months
- any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, Zhongzheng Dist, 100
About this study
Official title: Diaphragm and Sternocleidomastoid Muscle Activation Patterns During Different Loaded Inspiratory Muscle Performance in Patients With Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Inspiratory muscle weakness has been shown in patients with COPD, and inspiratory muscle training (IMT) is commonly applied to these patients. However, the optimal prescribed intensity of IMT for patients with COPD remains unclear. In healthy adults the accessory muscles would be recruited to assist ventilation with increasing ventilatory demand, but the activation pattern of accessory muscles has not been studied in patients with COPD during loaded condition such as IMT. Therefore, the purpose of this study is to exam diaphragm and sternocleidomastoid muscle activation using surface electromyography during loaded inspiratory muscle tests with intensity of 30% and 50% of maximal inspiratory pressure.
Read the detailed description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world in 2010, and it is expected to rise over the next 30 years. COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Studies have found evidences of inspiratory muscle weakness in patients with COPD which include a reduction in maximal inspiratory pressure (PImax), a shift toward oxidative type I fibers and atrophy in all types of fibers in diaphragm muscle. The shift of diaphragm muscle fiber toward oxidative type I fibers might result from endurance training-like effect that served to counteract the negative effects of elevated oxidative stress and systemic inflammation in patients with COPD.
Inspiratory muscle training (IMT) is commonly applied to patients with COPD during pulmonary rehabilitation, but its clinical benefits remain inconclusive. Some studies showed that IMT improves breathing pattern, dyspnea and the strength and endurance of diaphragm, while others showed that IMT could not improve inspiratory muscle strength and functional exercise capacity either applied alone or in addition to pulmonary rehabilitation in patients with COPD. Evidence from animal study showed that overloading the diaphragm during resistive breathing might induce acute diaphragm injury. Increases oxidative stress and systemic inflammation, and exacerbating the apoptosis of the diaphragm fibers may also occur during IMT in patients with COPD, which leads to the progression of diaphragm muscle fibers atrophy. In human studies, the intensity used for IMT ranged from 10% to 70% of PImax, and the training effect showed no clear dose-response pattern. The optimal intensity that would induce positive physiological effect without eliciting overloading injury remains unclear. In healthy adults, the accessory muscles, such as sternocleidomastoid (SCM), scalenes, and intercostals muscle, would be recruited to assist ventilation with increasing ventilatory demand. Thus the activation of accessory muscles could be an indicator for training overload. However, the activation pattern of accessory muscle has not been studied in patients with COPD during IMT. Whether the commonly prescribed intensity for IMT would lead to excessive activation of diaphragm, and more accessory muscle recruitment in patients with COPD remains to be determined. Therefore, the purpose of this study is to exam diaphragm and SCM muscle activation using surface electromyography during loaded inspiratory muscle tests with 30% and 50% of PImax intensity.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Loaded inspiratory muscle test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded inspiratory muscle testOther
Loaded inspiratory muscle tests will be set at 30% and 50% of maximal inspiratory pressure. The orders of the two loaded test conditions will be conducted in random order with at least 24 hours separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training.
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | Subjects with the diagnosis of chronic obstructive pulmonary disease, stable clinically, has no infection or acute exacerbation in the previous four weeks, and can cooperate with the measurements of this study, loaded inspiratory muscle test. Receives: Other: Loaded inspiratory muscle test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm and Sternocleidomastoid muscle activation
Root mean square values during different conditions
Measured: through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
The mean median frequency of diaphragm and sternocleidomastoid muscle
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Measured: In one minute after the completion of the loaded inspiratory muscle test condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start24 Apr 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
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 National Taiwan University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, Phd, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522376
- Sponsor's protocol ID
- 201802054RINB
- Status last verified
- Mar 2018
- First submitted
- 25 Mar 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm and Sternocleidomastoid Muscle Activation Patterns During Different Loaded Inspiratory Muscle Performance in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03522376
- Acronym / sponsor ID
- 201802054RINB
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 11 May 2018 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Inspiratory muscle weakness has been shown in patients with COPD, and inspiratory muscle training (IMT) is commonly applied to these patients. However, the optimal prescribed intensity of IMT for patients with COPD remains unclear. In healthy adults the accessory muscles would be recruited to assist ventilation with increasing ventilatory demand, but the activation pattern of accessory muscles has not been studied in patients with COPD during loaded condition such as IMT. Therefore, the purpose of this study is to exam diaphragm and sternocleidomastoid muscle activation using surface electromyography during loaded inspiratory muscle tests with intensity of 30% and 50% of maximal inspiratory pressure.
Detailed description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world in 2010, and it is expected to rise over the next 30 years. COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Studies have found evidences of inspiratory muscle weakness in patients with COPD which include a reduction in maximal inspiratory pressure (PImax), a shift toward oxidative type I fibers and atrophy in all types of fibers in diaphragm muscle. The shift of diaphragm muscle fiber toward oxidative type I fibers might result from endurance training-like effect that served to counteract the negative effects of elevated oxidative stress and systemic inflammation in patients with COPD.
Inspiratory muscle training (IMT) is commonly applied to patients with COPD during pulmonary rehabilitation, but its clinical benefits remain inconclusive. Some studies showed that IMT improves breathing pattern, dyspnea and the strength and endurance of diaphragm, while others showed that IMT could not improve inspiratory muscle strength and functional exercise capacity either applied alone or in addition to pulmonary rehabilitation in patients with COPD. Evidence from animal study showed that overloading the diaphragm during resistive breathing might induce acute diaphragm injury. Increases oxidative stress and systemic inflammation, and exacerbating the apoptosis of the diaphragm fibers may also occur during IMT in patients with COPD, which leads to the progression of diaphragm muscle fibers atrophy. In human studies, the intensity used for IMT ranged from 10% to 70% of PImax, and the training effect showed no clear dose-response pattern. The optimal intensity that would induce positive physiological effect without eliciting overloading injury remains unclear. In healthy adults, the accessory muscles, such as sternocleidomastoid (SCM), scalenes, and intercostals muscle, would be recruited to assist ventilation with increasing ventilatory demand. Thus the activation of accessory muscles could be an indicator for training overload. However, the activation pattern of accessory muscle has not been studied in patients with COPD during IMT. Whether the commonly prescribed intensity for IMT would lead to excessive activation of diaphragm, and more accessory muscle recruitment in patients with COPD remains to be determined. Therefore, the purpose of this study is to exam diaphragm and SCM muscle activation using surface electromyography during loaded inspiratory muscle tests with 30% and 50% of PImax intensity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | Other: Loaded inspiratory muscle testSubjects with the diagnosis of chronic obstructive pulmonary disease, stable clinically, has no infection or acute exacerbation in the previous four weeks, and can cooperate with the measurements of this study, loaded inspiratory muscle test. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Recent studies show that other than respiratory symptoms, patients with chronic obstructive pulmonary disease often present with inspiratory muscle weakness.
Key inclusion criteria (3 listed)
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
- can cooperate with the measurements of this study
Key exclusion criteria (5 listed)
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- participated in inspiratory muscle training program in the previous three months
- any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study
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 |
|---|---|---|
| Loaded inspiratory muscle testLoaded inspiratory muscle tests will be set at 30% and 50% of maximal inspiratory pressure. The orders of the two loaded test conditions will be conducted in random order with at least 24 hours separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. | Other | Chronic obstructive pulmonary disease |
Primary outcome
Diaphragm and Sternocleidomastoid muscle activation
Time frame: through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
Root mean square values during different conditions
The mean median frequency of diaphragm and sternocleidomastoid muscle
Time frame: In one minute after the completion of the loaded inspiratory muscle test condition
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Li-Ying Wang, Phd study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Feb 2019. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm and Sternocleidomastoid muscle activation (time frame: through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes). The study lists 2 primary outcomes in all. 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 12 Feb 2019.