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

Primary Purpose

Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic respiratory disease

Arm Description

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

Outcomes

Primary Outcome Measures

Diaphragm and Sternocleidomastoid muscle activation
Root mean square values during different conditions
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
Pulmonary function
Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
Maximal inspiratory pressure test
Maximal inspiratory pressure
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
Heart rate
Heart rate is measured at rest, during six-minute walk test
Blood pressure
systolic and diastolic pressure are measured at rest, after six-minute walk test
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).
Oxygen saturation
Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests

Secondary Outcome Measures

Full Information

First Posted
March 14, 2019
Last Updated
March 16, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03880630
Brief Title
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Official Title
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle, Surface Electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic respiratory disease
Arm Type
Experimental
Arm Description
Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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 Measure Information:
Title
Diaphragm and Sternocleidomastoid muscle activation
Description
Root mean square values during different conditions
Time Frame
through the completion of the inspiratory loading tests condition; it would take about 3 minutes
Title
The mean median frequency of diaphragm and sternocleidomastoid muscle
Description
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Time Frame
In five minute after the completion of the loaded inspiratory muscle test condition
Title
Pulmonary function
Description
Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
Time Frame
About five minutes to complete
Title
Maximal inspiratory pressure test
Description
Maximal inspiratory pressure
Time Frame
About three minutes to complete
Title
Functional exercise capacity using the six-minute walk test
Description
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
Time Frame
The six-minute walk test needs six minute to complete the test
Title
Heart rate
Description
Heart rate is measured at rest, during six-minute walk test
Time Frame
The six-minute walk test needs six minute to complete the test
Title
Blood pressure
Description
systolic and diastolic pressure are measured at rest, after six-minute walk test
Time Frame
Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure
Title
Perceived dyspnea
Description
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).
Time Frame
It takes less than one minute to evaluate perceived dyspnea
Title
Oxygen saturation
Description
Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ying Wang, Phd
Organizational Affiliation
National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
School & Graduate Institute of Physical Therapy, College of Medicine, NTU
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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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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