NCT03522376

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Inspiratory muscle weakness has been shown in patients with COPD, and inspiratory muscle training (IMT) is commonly applied to these patients. However, the optimal prescribed intensity of IMT for patients with COPD remains unclear. In healthy adults the accessory muscles would be recruited to assist ventilation with increasing ventilatory demand, but the activation pattern of accessory muscles has not been studied in patients with COPD during loaded condition such as IMT. Therefore, the purpose of this study is to exam diaphragm and sternocleidomastoid muscle activation using surface electromyography during loaded inspiratory muscle tests with intensity of 30% and 50% of maximal inspiratory pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

February 12, 2019

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 25, 2018

Last Update Submit

February 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diaphragm and Sternocleidomastoid muscle activation

    Root mean square values during different conditions

    through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes

  • The mean median frequency of diaphragm and sternocleidomastoid muscle

    The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability

    In one minute after the completion of the loaded inspiratory muscle test condition

Study Arms (1)

Chronic obstructive pulmonary disease

Subjects with the diagnosis of chronic obstructive pulmonary disease, stable clinically, has no infection or acute exacerbation in the previous four weeks, and can cooperate with the measurements of this study, loaded inspiratory muscle test.

Other: Loaded inspiratory muscle test

Interventions

Loaded inspiratory muscle tests will be set at 30% and 50% of maximal inspiratory pressure. The orders of the two loaded test conditions will be conducted in random order with at least 24 hours separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training.

Chronic obstructive pulmonary disease

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production. Recent studies show that other than respiratory symptoms, patients with chronic obstructive pulmonary disease often present with inspiratory muscle weakness.

You may qualify if:

  • age \> 20 years old
  • has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
  • can cooperate with the measurements of this study

You may not qualify if:

  • any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
  • angina, acute myocardial infarction in the previous one month
  • pregnancy
  • participated in inspiratory muscle training program in the previous three months
  • any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy of National Taiwan University

Taipei, Zhongzheng Dist, 100, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Li-Ying Wang, Phd

    National Taiwan University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 25, 2018

First Posted

May 11, 2018

Study Start

April 24, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

February 12, 2019

Record last verified: 2018-03

Locations