COPDNCT04857541
Breathing Performance of Healthy Young Adult
An observational study of COPD and COPD-like, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The study will recruit subject of healthy adult, COPD-like patient and patient with COPD to investigate the difference of respiratory performance. We will measure the body composition, respiratory muscle force, pulmonary function and performance of voluntary cough. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2021to 20 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Health subject: healthy adults with no existed respiratory condition 2. COPD-like subject: subjects with COPD-like symptoms but not reach the diagnosis criteria 3. COPD subject: subjects with diagnosed COPD
Who may be able to join
- aged 20 years or above
- currently not being diagnosis as COPD
- less than 4 times/week of aerobic exercise
- COPD-like subject
- aged 20 years or above
- currently not being diagnosis as COPD
Show all 12Show fewer
- presented of COPD symptoms (coughing, sputum production and dyspnea), last for 3 months and more than 2 years
- score more than 1 on modified Medical Research Council (mMRC) or COPD Assessment Test (CAT)
- COPD subject
- aged 20 years or above
- currently being diagnosis as COPD
- haven't participated in any pulmonary rehabilitation program in the past three months
Who cannot join
- Untreated comorbidities for COPD
- Postural asymmetries (Scoliosis, length discrepancy of the lower limbs or other previous surgical history of spine)
- Chronic nonspecific lumbopelvic pain
- Gynecological or abdominal surgery in the previous year
- Pregnancy or post-delivery in the previous 6 months
- Neurological or inflammatory disorders
- Any conditions that may interfere with the data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Breathing Performance of Healthy Young Adult
The study will recruit subject of healthy adult, COPD-like patient and patient with COPD to investigate the difference of respiratory performance. We will measure the body composition, respiratory muscle force, pulmonary function and performance of voluntary cough. The muscle thickness of abdominal muscle and diaphragm, assessment of diaphragm during different breathing pattern and the muscle activation during voluntary cough will also being determined. We hypothesized that there will be a significantly different between three group on the performance of voluntary cough, and the correlation between each variable will be further investigated.
Read the detailed description
The specific aims of the study are:
- difference of respiratory muscle performance between three groups
- the correlation between respiratory symptom and pulmonary functional test
- difference of functional respiratory performance (peak cough flow of voluntary cough) between three groups
- muscle activation of abdominal muscle and diaphragm during performing voluntary force
- performance of diaphragm under different breathing load
- Keywords
- COPD, Diaphragm, Voluntary cough, Abdominal muscle activation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Health adult | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cough flow
Peak coughing velocity of voluntary cough in liter/second
Measured: baseline
Secondary outcomes (8)
Respiratory muscle force
MIP/MEP in cmH2O
Measured: baseline
Pulmonary function test
PEF/MVV in liter/min
Measured: baseline
Pulmonary function test
FEV1/FVC/VT in liter
Measured: baseline
Pulmonary function test
MVV rate in breaths/min
Measured: baseline
Muscle thickness during voluntary force
tRA/tEO/tIO/tTrA/tD in millimeter
Measured: baseline
Muscle activation during voluntary force
aURA/aLRA/aEO/aIOTrA/aD (all the data will be collected through surface EMG and will be presented as maximal voluntary contraction in %)
Measured: baseline
Diaphragm assessment
QB_ex/DB_ex/Sniff_ex in millimeter
Measured: baseline
Diaphragm assessment
QB_slope/DB_slope/Sniff_slope in cm/s
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start11 May 2021
- Primary completion13 May 2021
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Hsia Hung, National Cheng Kung University
- Investigators
- Ching-Hsia Hung, PhD, Principal investigator, Department of physical therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857541
- Sponsor's protocol ID
- A-ER-110-051
- Status last verified
- Jun 2022
- First submitted
- 15 Apr 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.
PubMed 28082171Mesquita Montes A, Crasto C, de Melo CA, Santos R, Pereira S, Vilas-Boas JP. The effect of inspiratory and expiratory loads on abdominal muscle activity during breathing in subjects "at risk" for the development of chronic obstructive pulmonary disease and healthy. J Electromyogr Kinesiol. 2017 Jun;34:50-57. doi: 10.1016/j.jelekin.2017.03.005. Epub 2017 Mar 31.
PubMed 28399443
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Breathing Performance of Healthy Young Adult
- ClinicalTrials.gov ID
- NCT04857541
- Acronym / sponsor ID
- A-ER-110-051
- Keywords
- COPD, Diaphragm, Voluntary cough, Abdominal muscle activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 23 Apr 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.
The study will recruit subject of healthy adult, COPD-like patient and patient with COPD to investigate the difference of respiratory performance. We will measure the body composition, respiratory muscle force, pulmonary function and performance of voluntary cough. The muscle thickness of abdominal muscle and diaphragm, assessment of diaphragm during different breathing pattern and the muscle activation during voluntary cough will also being determined. We hypothesized that there will be a significantly different between three group on the performance of voluntary cough, and the correlation between each variable will be further investigated.
Detailed description
The specific aims of the study are:
- difference of respiratory muscle performance between three groups
- the correlation between respiratory symptom and pulmonary functional test
- difference of functional respiratory performance (peak cough flow of voluntary cough) between three groups
- muscle activation of abdominal muscle and diaphragm during performing voluntary force
- performance of diaphragm under different breathing load
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health adult | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Health subject: healthy adults with no existed respiratory condition 2. COPD-like subject: subjects with COPD-like symptoms but not reach the diagnosis criteria 3. COPD subject: subjects with diagnosed COPD
Key inclusion criteria (12 listed)
- COPD-like subject
- COPD subject
- aged 20 years or above
- currently being diagnosis as COPD
- haven't participated in any pulmonary rehabilitation program in the past three months
Key exclusion criteria (7 listed)
- Untreated comorbidities for COPD
- Postural asymmetries (Scoliosis, length discrepancy of the lower limbs or other previous surgical history of spine)
- Chronic nonspecific lumbopelvic pain
- Gynecological or abdominal surgery in the previous year
- Pregnancy or post-delivery in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak cough flow
Time frame: baseline
Peak coughing velocity of voluntary cough in liter/second
8 secondary outcomes
Respiratory muscle force
Time frame: baseline
Pulmonary function test
Time frame: baseline
Pulmonary function test
Time frame: baseline
Pulmonary function test
Time frame: baseline
Muscle thickness during voluntary force
Time frame: baseline
Muscle activation during voluntary force
Time frame: baseline
Diaphragm assessment
Time frame: baseline
Diaphragm assessment
Time frame: baseline
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 10 Jun 2022.
- Background: PubMed 28082171Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.
- Background: PubMed 28399443Mesquita Montes A, Crasto C, de Melo CA, Santos R, Pereira S, Vilas-Boas JP. The effect of inspiratory and expiratory loads on abdominal muscle activity during breathing in subjects "at risk" for the development of chronic obstructive pulmonary disease and healthy. J Electromyogr Kinesiol. 2017 Jun;34:50-57. doi: 10.1016/j.jelekin.2017.03.005. Epub 2017 Mar 31.
- 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.
Ching-Hsia Hung, PhD principal investigator
Department of physical therapy, National Cheng Kung 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 COPD and COPD-like, run by National Cheng-Kung 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 12 inclusion and 7 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 10 Jun 2022. 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?
Peak cough flow (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04857541, which also lists 2 linked publications.
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 10 Jun 2022.