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

Chronic Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880630
• Other study ID #: 201812172RIND
• Status: Completed
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Inspiratory Muscle Training
• Respiration Disorders
• Respiratory Aspiration
• Respiratory Tract Diseases
• Sternocleidomastoid Muscle
• Surface Electromyography

Intervention

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.

Locations

Country	Name	City	State
Taiwan	School & Graduate Institute of Physical Therapy, College of Medicine, NTU	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Pulmonary function	Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity	About five minutes to complete
Primary	Maximal inspiratory pressure test	Maximal inspiratory pressure	About three minutes to complete
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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