The Inspiratory Muscle Activation Pattern and Training Efficacy in Patients With Chronic Obstructive Pulmonary Disease After Acute Exacerbation

NCT ID: NCT04316312

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2021-03-31

Brief Summary

The purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Null hypothesis (H0): There is no significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation. Alternative hypothesis (H1): There is significant difference between activation pattern of diaphragm and SCM muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.

Detailed Description

The prevalence of chronic obstructive pulmonary disease (COPD) is 11.7% around the world, and it is expected to rise over the next 30 years. In Taiwan, COPD is estimated as the seventh leading cause of death in 2016, and has been gradually increasing in the past decades. COPD has been long considered to be a disease state characterized by airflow limitation that are not fully reversible, leading to abnormalities in control of breathing, worsening of respiratory mechanics and pulmonary function. However, COPD is no longer considered to affect only the lungs and airways, but also the rest of the body including decreases in respiratory and limb-muscle mass and function. When acute exacerbation occurs, lung function decreases rapidly. According to the previous studies, inspiratory muscle training (IMT), can improve the strength and endurance of the diaphragm, reduce dyspnea and breathing pattern, thus increasing the capacity of activities tolerance in patients with COPD. Although more and more studies are focus on diaphragm weakness and the effect of IMT in patients with COPD, the efficacy and intensity of IMT in patients with COPD is still controversial and the clinical use is limited. Whether increases intensity during IMT would lead to improvements in contraction pattern of respiratory muscle remained unclear. Therefore, the purpose of this study is to assess the activation patterns of diaphragm and sternocleidomastoid (SCM) muscle during different loaded inspiratory muscle performance in patients with COPD after acute exacerbation.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inspiratory muscle training group

Group Type: EXPERIMENTAL

Threshold inspiratory muscle trainer

Intervention Type: DEVICE

Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.

Interventions

Threshold inspiratory muscle trainer

Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age > 20 years old
• has been diagnosis of chronic obstructive pulmonary disease and experienced at least 2 times of acute exacerbation in recent 6 months
• can cooperate with the measurements of this study

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Ying Wang, PhD

Role: STUDY_CHAIR

National Taiwan University

Locations

School and Graduate Institute of Physical Therapy of National Taiwan University

Taipei, Zhongzheng Dist, Taiwan

Countries

Taiwan

Other Identifiers

201912165RINB

Identifier Type: -

Identifier Source: org_study_id