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

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ClinicalTrials.gov Identifier: NCT03880630
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Respiratory Disease Inspiratory Muscle Training Sternocleidomastoid Muscle Surface Electromyography Other: Inspiratory muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880630


Contacts
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Contact: Chien-Tzu Lee +886912793976 twilight0428@gmail.com
Contact: Chien-Tzu Chien-Tzu +886912793976 r05428009@ntu.edu.tw

Locations
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Taiwan
School & Graduate Institute of Physical Therapy, College of Medicine, NTU
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Li-Ying Wang, Phd National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03880630     History of Changes
Other Study ID Numbers: 201812172RIND
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes