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

Not Applicable

Completed

• Conditions: Chronic Respiratory Disease; Inspiratory Muscle Training; Sternocleidomastoid Muscle; Surface Electromyography
• Interventions: Other: Inspiratory muscle training

• Registration Number: NCT03880630
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-17
• Study First Posted: 2019-03-19
• Status Verified: 2020-03
• Study Start: 2020-10-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic respiratory disease	Inspiratory muscle training	Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study

Primary Outcome Measures

Name	Time	Method
Diaphragm and Sternocleidomastoid muscle activation	through the completion of the inspiratory loading tests condition; it would take about 3 minutes	Root mean square values during different conditions
Pulmonary function	About five minutes to complete	Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
The mean median frequency of diaphragm and sternocleidomastoid muscle	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
Maximal inspiratory pressure test	About three minutes to complete	Maximal inspiratory pressure
Functional exercise capacity using the six-minute walk test	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	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	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	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	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

Trial Locations

Locations (1)

School & Graduate Institute of Physical Therapy, College of Medicine, NTU; 🇨🇳 Taipei, Taiwan