Chronic Obstructive Pulmonary DiseaseNCT04146948
The Differences of Muscle Activity Between Patients With COPD and Healthy Adults
An observational study of Chronic Obstructive Pulmonary Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during ADL between patients with COPD and age-matched healthy participants. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with COPD will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital
Who may be able to join
- 40 years or older
- With the clinical diagnosis of COPD
Who cannot join
- With the clinical diagnosis of asthma or cancer
- With cardiovascular, musculoskeletal and neurological diseases limiting physical activities in daily life
- In the unstable medical state
- MMSE under 25
- Barthel index score under 61
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University
Tainan, 701
Li-Chieh Kuo, Ph. D., 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
About this study
Official title: Comparing Activity of Accessory Inspiratory Muscles and Upper Limb Muscles During Performing Activities of Daily Living Between Patients With Chronic Obstructive Pulmonary Disease and Healthy Adults
The purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during ADL between patients with COPD and age-matched healthy participants.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- no intervention
- Keywords
- activities of daily living, accessory inspiratory muscles, oxygen consumption, minute ventilation volume
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| COPD group | No intervention 40 years or older, clinical diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease stages I to IV) Receives: Other: no intervention | |
| healthy group | 40 years or older, not with the clinical diagnosis of COPD Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise testing device
The machine analyze the breath of participants including oxygen consumption and minute ventilation volume. Oxygen consumption is reported in mL/min and minute ventilation volume is reported in L/min.
Measured: baseline
Surface electromyography device
The surface EMG is performed to assess the maximum voluntary contraction and muscle activity of upper limb muscles and accessory inspiratory muscles during performing simulated ADL tasks. The maximal voluntary contraction (MVC) is used as the reference level of muscle activity to normalize the EMG data of performing simulated ADL tasks. The muscle activity is reported in percentage.
Measured: baseline
The clinical Chronic Obstructive Pulmonary Disease questionnaire
This is a self-reported questionnaire to measure the impact of COPD on participants' health status. The rating scores is a 7-point scale (0=no limitation, 6=totally limited).Higher scores mean the more severe impact of COPD on participants' daily living.
Measured: baseline
Modified Borg Scale
This is a self-reported scale to measure how much participants perceive dyspnea. The range from 0 which means no difficulty to breathe to 10 which means with maximal difficulty to breathe.
Measured: baseline
Modified Medical Research Council
This is a five-point scale to assess the severity of breathlessness.
Measured: baseline
Secondary outcomes (1)
EQ-5D questionnaire
This is a self-reported questionnaire for measuring generic health status
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start22 Jan 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146948
- Sponsor's protocol ID
- A-ER-108-273
- Status last verified
- Mar 2021
- First submitted
- 28 Oct 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen CY, Hsu CH, Tsai SH, Lin CF, Lin YC, Hsu HY, Chen CZ, Kuo LC. Association Between Muscle Activity of Upper Limbs and Respiratory Parameters During Functional Performance in People With Chronic Obstructive Pulmonary Disease. Occup Ther Int. 2025 Mar 25;2025:3023322. doi: 10.1155/oti/3023322. eCollection 2025.
PubMed 40171139
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Activity of Accessory Inspiratory Muscles and Upper Limb Muscles During Performing Activities of Daily Living Between Patients With Chronic Obstructive Pulmonary Disease and Healthy Adults
- ClinicalTrials.gov ID
- NCT04146948
- Acronym / sponsor ID
- A-ER-108-273
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- activities of daily living, accessory inspiratory muscles, oxygen consumption, minute ventilation volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during ADL between patients with COPD and age-matched healthy participants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | Other: no interventionNo intervention 40 years or older, clinical diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease stages I to IV) |
| healthy group | – | Other: no intervention40 years or older, not with the clinical diagnosis of COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with COPD will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital
Key inclusion criteria (2 listed)
- 40 years or older
- With the clinical diagnosis of COPD
Key exclusion criteria (5 listed)
- With the clinical diagnosis of asthma or cancer
- With cardiovascular, musculoskeletal and neurological diseases limiting physical activities in daily life
- In the unstable medical state
- MMSE under 25
- Barthel index score under 61
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention in this study | Other | COPD group, healthy group |
Primary outcome
Cardiopulmonary exercise testing device
Time frame: baseline
The machine analyze the breath of participants including oxygen consumption and minute ventilation volume. Oxygen consumption is reported in mL/min and minute ventilation volume is reported in L/min.
Surface electromyography device
Time frame: baseline
The surface EMG is performed to assess the maximum voluntary contraction and muscle activity of upper limb muscles and accessory inspiratory muscles during performing simulated ADL tasks. The maximal voluntary contraction (MVC) is used as the reference level of muscle activity to normalize the EMG data of performing simulated ADL tasks. The muscle activity is reported in percentage.
The clinical Chronic Obstructive Pulmonary Disease questionnaire
Time frame: baseline
This is a self-reported questionnaire to measure the impact of COPD on participants' health status. The rating scores is a 7-point scale (0=no limitation, 6=totally limited).Higher scores mean the more severe impact of COPD on participants' daily living.
Modified Borg Scale
Time frame: baseline
This is a self-reported scale to measure how much participants perceive dyspnea. The range from 0 which means no difficulty to breathe to 10 which means with maximal difficulty to breathe.
Modified Medical Research Council
Time frame: baseline
This is a five-point scale to assess the severity of breathlessness.
1 secondary outcome
EQ-5D questionnaire
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 40171139Chen CY, Hsu CH, Tsai SH, Lin CF, Lin YC, Hsu HY, Chen CZ, Kuo LC. Association Between Muscle Activity of Upper Limbs and Respiratory Parameters During Functional Performance in People With Chronic Obstructive Pulmonary Disease. Occup Ther Int. 2025 Mar 25;2025:3023322. doi: 10.1155/oti/3023322. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise testing device (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.