Breathing Performance of Healthy Young Adult

COPD Clinical Trial

Official title:

Investigation of Breathing Performance of Healthy Young Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857541
• Other study ID #: A-ER-110-051
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: June 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 20, 2022
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak cough flow	Peak coughing velocity of voluntary cough in liter/second	baseline
Secondary	Respiratory muscle force	MIP/MEP in cmH2O	baseline
Secondary	Pulmonary function test	PEF/MVV in liter/min	baseline
Secondary	Pulmonary function test	FEV1/FVC/VT in liter	baseline
Secondary	Pulmonary function test	MVV rate in breaths/min	baseline
Secondary	Muscle thickness during voluntary force	tRA/tEO/tIO/tTrA/tD in millimeter	baseline
Secondary	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 %)	baseline
Secondary	Diaphragm assessment	QB_ex/DB_ex/Sniff_ex in millimeter	baseline
Secondary	Diaphragm assessment	QB_slope/DB_slope/Sniff_slope in cm/s	baseline