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

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.

Study Overview

• Status: Completed
• Conditions: Surface Electromyography; Inspiratory Muscle Training; Chronic Respiratory Disease; Sternocleidomastoid Muscle
• Intervention / Treatment: Other: Inspiratory muscle training

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • School & Graduate Institute of Physical Therapy, College of Medicine, NTU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 17, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 201812172RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No