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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04146948
Other study ID # A-ER-108-273
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2020
Est. completion date December 2021

Study information

Verified date March 2021
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - 40 years or older - With the clinical diagnosis of COPD Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention in this study

Locations

Country Name City State
Taiwan National Cheng-Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Modified Medical Research Council This is a five-point scale to assess the severity of breathlessness. baseline
Secondary EQ-5D questionnaire This is a self-reported questionnaire for measuring generic health status baseline
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