Clincosm LogoSign in Get a demo

Breathing Performance of Healthy Young Adult

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04857541
Collaborator
(none)
65
Enrollment
1
Location
11.3
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    65 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Investigation of Breathing Performance of Healthy Young Adult
    Actual Study Start Date :
    May 11, 2021
    Actual Primary Completion Date :
    May 13, 2021
    Actual Study Completion Date :
    Apr 20, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Health adult

    Outcome Measures

    Primary Outcome Measures

    1. Peak cough flow [baseline]

      Peak coughing velocity of voluntary cough in liter/second

    Secondary Outcome Measures

    1. Respiratory muscle force [baseline]

      MIP/MEP in cmH2O

    2. Pulmonary function test [baseline]

      PEF/MVV in liter/min

    3. Pulmonary function test [baseline]

      FEV1/FVC/VT in liter

    4. Pulmonary function test [baseline]

      MVV rate in breaths/min

    5. Muscle thickness during voluntary force [baseline]

      tRA/tEO/tIO/tTrA/tD in millimeter

    6. Muscle activation during voluntary force [baseline]

      aURA/aLRA/aEO/aIOTrA/aD (all the data will be collected through surface EMG and will be presented as maximal voluntary contraction in %)

    7. Diaphragm assessment [baseline]

      QB_ex/DB_ex/Sniff_ex in millimeter

    8. Diaphragm assessment [baseline]

      QB_slope/DB_slope/Sniff_slope in cm/s

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    1. Health subject
    Inclusion Criteria:

    • aged 20 years or above

    • currently not being diagnosis as COPD

    • less than 4 times/week of aerobic exercise

    1. 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)

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cheng Kung University Hospital Tainan Taiwan 704

    Sponsors and Collaborators

    • National Cheng-Kung University Hospital

    Investigators

    • Principal Investigator: Ching-Hsia Hung, PhD, Department of physical therapy, National Cheng Kung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ching-Hsia Hung, Professor, National Cheng Kung University
    ClinicalTrials.gov Identifier:
    NCT04857541
    Other Study ID Numbers:
    • A-ER-110-051
    First Posted:
    Apr 23, 2021
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ching-Hsia Hung, Professor, National Cheng Kung University
    COPD
    Diaphragm
    Voluntary cough
    Abdominal muscle activation
    Additional relevant MeSH terms:
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Jun 10, 2022