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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

  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

Description

  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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Health adult

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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