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NCT Number: NCT03880630

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.

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Key information

Conditions

Chronic Respiratory Disease Inspiratory Muscle Training Sternocleidomastoid Muscle Surface Electromyography

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diaphragm and Sternocleidomastoid muscle activation

    Time frame: through the completion of the inspiratory loading tests condition; it would take about 3 minutes

    Root mean square values during different conditions

  2. The mean median frequency of diaphragm and sternocleidomastoid muscle

    Time frame: In five minute after the completion of the loaded inspiratory muscle test condition

    The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability

  3. Pulmonary function

    Time frame: About five minutes to complete

    Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity

  4. Maximal inspiratory pressure test

    Time frame: About three minutes to complete

    Maximal inspiratory pressure

  5. Functional exercise capacity using the six-minute walk test

    Time frame: The six-minute walk test needs six minute to complete the 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

  6. Heart rate

    Time frame: The six-minute walk test needs six minute to complete the test

    Heart rate is measured at rest, during six-minute walk test

  7. Blood pressure

    Time frame: Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure

    systolic and diastolic pressure are measured at rest, after six-minute walk test

  8. Perceived dyspnea

    Time frame: It takes less than one minute to evaluate 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).

  9. Oxygen saturation

    Time frame: 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

    Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2019
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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