Clinical trial NCT04857541: Breathing Performance of Healthy Young Adult
Official title: Investigation of Breathing Performance of Healthy Young Adult
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
COPD-like
Keywords: COPD
Diaphragm
Voluntary cough
Abdominal muscle activation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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:

1. difference of respiratory muscle performance between three groups
2. the correlation between respiratory symptom and pulmonary functional test
3. difference of functional respiratory performance (peak cough flow of voluntary cough) between three groups
4. muscle activation of abdominal muscle and diaphragm during performing voluntary force
5. performance of diaphragm under different breathing load

Eligibility criteria: 1. Health subject

   Inclusion Criteria:
   * aged 20 years or above
   * currently not being diagnosis as COPD
   * less than 4 times/week of aerobic exercise
2. 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)
3. 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

Primary outcomes:
measure: Peak cough flow
timeFrame: baseline
Secondary outcomes:
measure: Respiratory muscle force
timeFrame: baseline
measure: Pulmonary function test
timeFrame: baseline
measure: Pulmonary function test
timeFrame: baseline
measure: Pulmonary function test
timeFrame: baseline
measure: Muscle thickness during voluntary force
timeFrame: baseline
measure: Muscle activation during voluntary force
timeFrame: baseline
measure: Diaphragm assessment
timeFrame: baseline
measure: Diaphragm assessment
timeFrame: baseline
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of physical therapy, National Cheng Kung University
name: Ching-Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.