Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
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|ClinicalTrials.gov Identifier: NCT03880630|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Respiratory Disease Inspiratory Muscle Training Sternocleidomastoid Muscle Surface Electromyography||Other: Inspiratory muscle training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Experimental: Chronic respiratory disease
Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study
Other: Inspiratory muscle training
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.
- Diaphragm and Sternocleidomastoid muscle activation [ Time Frame: through the completion of the inspiratory loading tests condition; it would take about 3 minutes ]Root mean square values during different conditions
- The mean median frequency of diaphragm and sternocleidomastoid muscle [ Time Frame: In five minute after the completion of the loaded inspiratory muscle test condition ]The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
- Pulmonary function [ Time Frame: About five minutes to complete ]Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
- Maximal inspiratory pressure test [ Time Frame: About three minutes to complete ]Maximal inspiratory pressure
- Functional exercise capacity using the six-minute walk test [ Time Frame: The six-minute walk test needs six minute to complete the 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
- Heart rate [ Time Frame: The six-minute walk test needs six minute to complete the test ]Heart rate is measured at rest, during six-minute walk test
- Blood pressure [ Time Frame: Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure ]systolic and diastolic pressure are measured at rest, after six-minute walk test
- Perceived dyspnea [ Time Frame: It takes less than one minute to evaluate 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).
- Oxygen saturation [ Time Frame: 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 ]Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880630
|Contact: Chien-Tzu Leefirstname.lastname@example.org|
|Contact: Chien-Tzu Chien-Tzuemail@example.com|
|School & Graduate Institute of Physical Therapy, College of Medicine, NTU|
|Taipei, Taiwan, 100|
|Study Chair:||Li-Ying Wang, Phd||National Taiwan University|