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

NCT03880630 | Completed

• 1 other identifier: 201812172RIND
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Chronic respiratory disease

EXPERIMENTAL

Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training OTHER

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.

Chronic respiratory disease

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School & Graduate Institute of Physical Therapy, College of Medicine, NTU

Taipei, 100, Taiwan

Location

Study Officials

• Li-Ying Wang, Phd

  National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 19, 2019
• Study Start: October 6, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 18, 2021

Record last verified: 2020-03

Locations

TW (1)