Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation

Study Overview
=================
Brief Summary
-----------------
Inspiratory muscle weakness, limited functional exercise capacity and worse quality of life have been shown in patients with exacerbation of chronic obstructive pulmonary disease (COPD). Recommendations from clinical practice guideline state that promoting pulmonary rehabilitation after exacerbation can improve the conditions above. Inspiratory muscle training (IMT) has been proven to enhance inspiratory muscle strength and endurance in patient with stable COPD. However, there is less research on whether IMT in addition to pulmonary rehabilitation after exacerbation can benefit inspiratory muscle function, functional exercise capacity and quality of life in patients with COPD. The purpose of this study is to examine the effects of IMT in addition to pulmonary rehabilitation on respiratory muscle function, functional exercise capacity and quality of life in patients with exacerbation of chronic obstructive pulmonary disease.

Official Title
-----------------
Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation

Conditions
-----------------
Exacerbation Copd

Intervention / Treatment
-----------------
* Other: inspiratory muscle training
* Other: pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 20 years old diagnosed as exacerbation of COPD maximal inspiratory pressure (MIP) < 80 cmH2O 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training combined pulmonary rehabilitation<br> | Other: inspiratory muscle training<br>* Intensity of inspiratory muscle training will be set at 30% of maximal inspiratory pressure. Subjects in intervention experimental group will perform 15 breaths per set, 6 sets per day on daily basis. The intervention will be last for 8 weeks.<br>Other: pulmonary rehabilitation<br>* Pulmonary rehabilitation consists of aerobic exercise training, strength training, and education related to airway clearance and drug utilization. All of subjects will receive 8-week pulmonary rehabilitation.<br>|
| Sham Comparator: Sham inspiratory muscle training combined pulmonary rehabilitation<br> | Other: pulmonary rehabilitation<br>* Pulmonary rehabilitation consists of aerobic exercise training, strength training, and education related to airway clearance and drug utilization. All of subjects will receive 8-week pulmonary rehabilitation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm muscle activation | The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia). | 10 minutes | 
| Sternocleidomastoid muscle activation | The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGSCM). | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 fatigue. | 10 minutes | 
| Functional exercise capacity | Six-minute walking test will be performed to evaluate functional exercise capacity. | Considering time of test and recovery, it will be expected to take totally 10 minutes. | 
| Quality of life evaluation | St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life. | 10 minutes |