Clinical trial NCT03880630: Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Official title: Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Disease
Inspiratory Muscle Training
Sternocleidomastoid Muscle
Surface Electromyography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Diaphragm and Sternocleidomastoid muscle activation
timeFrame: through the completion of the inspiratory loading tests condition; it would take about 3 minutes
measure: The mean median frequency of diaphragm and sternocleidomastoid muscle
timeFrame: In five minute after the completion of the loaded inspiratory muscle test condition
measure: Pulmonary function
timeFrame: About five minutes to complete
measure: Maximal inspiratory pressure test
timeFrame: About three minutes to complete
measure: Functional exercise capacity using the six-minute walk test
timeFrame: The six-minute walk test needs six minute to complete the test
measure: Heart rate
timeFrame: The six-minute walk test needs six minute to complete the test
measure: Blood pressure
timeFrame: Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure
measure: Perceived dyspnea
timeFrame: It takes less than one minute to evaluate perceived dyspnea
measure: Oxygen saturation
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School & Graduate Institute of Physical Therapy, College of Medicine, NTU
Study officials:
affiliation: National Taiwan University
name: Li-Ying Wang, Phd
role: STUDY_CHAIR
References: