NCT04146948

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

October 28, 2019

Last Update Submit

March 31, 2021

Conditions

Keywords

activities of daily livingaccessory inspiratory musclesoxygen consumptionminute ventilation volume

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    baseline

  • Modified Medical Research Council

    This is a five-point scale to assess the severity of breathlessness.

    baseline

Secondary Outcomes (1)

  • EQ-5D questionnaire

    baseline

Study Arms (2)

COPD group

No intervention 40 years or older, clinical diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease stages I to IV)

Other: no intervention

healthy group

40 years or older, not with the clinical diagnosis of COPD

Other: no intervention

Interventions

no intervention in this study

COPD grouphealthy group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with COPD will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital

You may qualify if:

  • years or older
  • With the clinical diagnosis of COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 31, 2019

Study Start

January 22, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations