- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857541
Breathing Performance of Healthy Young Adult
June 9, 2022 updated by: Ching-Hsia Hung, National Cheng-Kung University Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Health subject: healthy adults with no existed respiratory condition
- COPD-like subject: subjects with COPD-like symptoms but not reach the diagnosis criteria
- COPD subject: subjects with diagnosed COPD
Description
Health subject
Inclusion Criteria:
- aged 20 years or above
- currently not being diagnosis as COPD
- less than 4 times/week of aerobic exercise
COPD-like subject
Inclusion Criteria:
- aged 20 years or above
- currently not being diagnosis as COPD
- 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
Inclusion Criteria:
- aged 20 years or above
- currently being diagnosis as COPD
- haven't participated in any pulmonary rehabilitation program in the past three months
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Health adult
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak cough flow
Time Frame: baseline
|
Peak coughing velocity of voluntary cough in liter/second
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory muscle force
Time Frame: baseline
|
MIP/MEP in cmH2O
|
baseline
|
|
Pulmonary function test
Time Frame: baseline
|
PEF/MVV in liter/min
|
baseline
|
|
Pulmonary function test
Time Frame: baseline
|
FEV1/FVC/VT in liter
|
baseline
|
|
Pulmonary function test
Time Frame: baseline
|
MVV rate in breaths/min
|
baseline
|
|
Muscle thickness during voluntary force
Time Frame: baseline
|
tRA/tEO/tIO/tTrA/tD in millimeter
|
baseline
|
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Muscle activation during voluntary force
Time Frame: baseline
|
aURA/aLRA/aEO/aIOTrA/aD (all the data will be collected through surface EMG and will be presented as maximal voluntary contraction in %)
|
baseline
|
|
Diaphragm assessment
Time Frame: baseline
|
QB_ex/DB_ex/Sniff_ex in millimeter
|
baseline
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Diaphragm assessment
Time Frame: baseline
|
QB_slope/DB_slope/Sniff_slope in cm/s
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ching-Hsia Hung, PhD, Department of Physical Therapy, National Cheng Kung University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Mesquita 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2021
Primary Completion (Actual)
May 13, 2021
Study Completion (Actual)
April 20, 2022
Study Registration Dates
First Submitted
April 15, 2021
First Submitted That Met QC Criteria
April 20, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-110-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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