Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease

Study Overview
=================
Brief Summary
-----------------
Background & Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive. The purposes of the study are to investigate in patients with chronic respiratory disease: (Year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various IMT loading using group-based trajectory modeling (GBTM); and (Year 2) effectiveness of individualized IMT program (based on results of Year 1) on clinical outcomes. Methods: (Year 1) Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Surface electromyography (EMG) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. Other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. Inspiratory muscle activation will be used for GBTM analysis. Patient will then be trained with individualized IMT program based on the GBTM analysis input form results of Year 1.

Official Title
-----------------
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease

Conditions
-----------------
Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle, Surface Electromyography

Intervention / Treatment
-----------------
* Other: Inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic respiratory disease<br>Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study | Other: Inspiratory muscle training<br>* Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Patient will then be trained with individualized IMT program based on the results of 3 inspiratory loading tests.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm and Sternocleidomastoid muscle activation | Root mean square values during different conditions | through the completion of the inspiratory loading tests 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 five minute after the completion of the loaded inspiratory muscle test condition | 
| Pulmonary function | Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity | About five minutes to complete | 
| Maximal inspiratory pressure test | Maximal inspiratory pressure | About three minutes to complete | 
| Functional exercise capacity using the six-minute walk test | The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity | The six-minute walk test needs six minute to complete the test | 
| Heart rate | Heart rate is measured at rest, during six-minute walk test | The six-minute walk test needs six minute to complete the test | 
| Blood pressure | systolic and diastolic pressure are measured at rest, after six-minute walk test | Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure | 
| Perceived dyspnea | Rating of perceived dyspnea is measured by using Borg scale at rest, during six-minute walk test, inspiratory loading tests. The most widely used tool is the Borg scale, with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea). | It takes less than one minute to evaluate perceived dyspnea | 
| Oxygen saturation | Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests | The six-minute walk test needs six minute to complete the test; through the completion of the inspiratory loading tests condition; it would take about 3 minutes |