Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT04316312
The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
A study testing Threshold inspiratory muscle trainer in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Threshold inspiratory muscle trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jan 2021to 31 Mar 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
- 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
The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Null hypothesis (H0): There is no significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Alternative hypothesis (H1): There is significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
Read the detailed description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world, and it is expected to rise over the next 30 years. In Taiwan, COPD is estimated as the seventh leading cause of death in 2016, and has been gradually increasing in the past decades. COPD has been long considered to be a disease state characterized by airflow limitation that are not fully reversible, leading to abnormalities in control of breathing, worsening of respiratory mechanics and pulmonary function. However, COPD is no longer considered to affect only the lungs and airways, but also the rest of the body including decreases in respiratory and limb-muscle mass and function. When acute exacerbation occurs, lung function decreases rapidly. According to the previous studies, inspiratory muscle training (IMT), can improve the strength and endurance of the diaphragm, reduce dyspnea and breathing pattern, thus increasing the capacity of activities tolerance in patients with COPD. Although more and more studies are focus on diaphragm weakness and the effect of IMT in patients with COPD, the efficacy and intensity of IMT in patients with COPD is still controversial and the clinical use is limited. Whether increases intensity during IMT would lead to improvements in contraction pattern of respiratory muscle remained unclear. Therefore, the purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
- Being tested
- Threshold inspiratory muscle trainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold inspiratory muscle trainerDevice
Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | Not described Receives: Device: Threshold inspiratory muscle trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm and Sternocleidomastoid muscle activation
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm and SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm and SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia and %EMGSCM).
Measured: through the completion of the maximal inspiratory pressure test and loaded inspiratory muscle test condition; totally it would take about 3 minutes
Secondary outcomes (1)
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 fatigue.
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 posted20 Mar 2020
- Study start12 Jan 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT04316312
- Sponsor's protocol ID
- 201912165RINB
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2020
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation
- ClinicalTrials.gov ID
- NCT04316312
- Acronym / sponsor ID
- 201912165RINB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Mar 2020 (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.
The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Null hypothesis (H0): There is no significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Alternative hypothesis (H1): There is significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
Detailed description
The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world, and it is expected to rise over the next 30 years. In Taiwan, COPD is estimated as the seventh leading cause of death in 2016, and has been gradually increasing in the past decades. COPD has been long considered to be a disease state characterized by airflow limitation that are not fully reversible, leading to abnormalities in control of breathing, worsening of respiratory mechanics and pulmonary function. However, COPD is no longer considered to affect only the lungs and airways, but also the rest of the body including decreases in respiratory and limb-muscle mass and function. When acute exacerbation occurs, lung function decreases rapidly. According to the previous studies, inspiratory muscle training (IMT), can improve the strength and endurance of the diaphragm, reduce dyspnea and breathing pattern, thus increasing the capacity of activities tolerance in patients with COPD. Although more and more studies are focus on diaphragm weakness and the effect of IMT in patients with COPD, the efficacy and intensity of IMT in patients with COPD is still controversial and the clinical use is limited. Whether increases intensity during IMT would lead to improvements in contraction pattern of respiratory muscle remained unclear. Therefore, the purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Device: Threshold inspiratory muscle trainer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
- 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 |
|---|---|---|
| Threshold inspiratory muscle trainerThreshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure. | Device | Inspiratory muscle training group |
Primary outcome
Diaphragm and Sternocleidomastoid muscle activation
Time frame: through the completion of the maximal inspiratory pressure test and loaded inspiratory muscle test condition; totally it would take about 3 minutes
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm and SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm and SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia and %EMGSCM).
1 secondary outcome
The mean median frequency of diaphragm and sternocleidomastoid muscle
Time frame: In one minute after the completion of the loaded inspiratory muscle test condition
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 8 Apr 2021.
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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?
A study testing Threshold inspiratory muscle trainer in people with Acute Exacerbation 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 8 Apr 2021. 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 maximal inspiratory pressure test and loaded inspiratory muscle test condition; totally it would take about 3 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 8 Apr 2021.