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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03880630
Enrollment
1
Registered
2019-03-19
Start date
2020-10-06
Completion date
2020-12-31
Last updated
2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERInspiratory 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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm and Sternocleidomastoid muscle activationthrough the completion of the inspiratory loading tests condition; it would take about 3 minutesRoot mean square values during different conditions
The mean median frequency of diaphragm and sternocleidomastoid muscleIn five minute after the completion of the loaded inspiratory muscle test conditionThe power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Pulmonary functionAbout five minutes to completeForced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
Maximal inspiratory pressure testAbout three minutes to completeMaximal inspiratory pressure
Functional exercise capacity using the six-minute walk testThe six-minute walk test needs six minute to complete the testThe 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 rateThe six-minute walk test needs six minute to complete the testHeart rate is measured at rest, during six-minute walk test
Blood pressureBefore and immediately after the six-minute walk test;it takes less than one minute to measure blood pressuresystolic and diastolic pressure are measured at rest, after six-minute walk test
Perceived dyspneaIt takes less than one minute to evaluate perceived dyspneaRating 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 saturationThe 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 minutesOxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026