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Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation

Primary Purpose

Exacerbation Copd

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

About this trial

This is an interventional supportive care trial for Exacerbation Copd

Eligibility Criteria

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

Inclusion Criteria:

  • age > 20 years old
  • diagnosed as exacerbation of COPD
  • maximal inspiratory pressure (MIP) < 80 cmH2O

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 and Graduate Institute of Physical Therapy of National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory muscle training combined pulmonary rehabilitation

Sham inspiratory muscle training combined pulmonary rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Diaphragm muscle activation
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia).
Sternocleidomastoid muscle activation
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGSCM).

Secondary Outcome Measures

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 fatigue.
Functional exercise capacity
Six-minute walking test will be performed to evaluate functional exercise capacity.
Quality of life evaluation
St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.

Full Information

First Posted
March 15, 2021
Last Updated
February 9, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04802096
Brief Title
Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation
Official Title
Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (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
Inspiratory muscle weakness, limited functional exercise capacity and worse quality of life have been shown in patients with exacerbation of chronic obstructive pulmonary disease (COPD). Recommendations from clinical practice guideline state that promoting pulmonary rehabilitation after exacerbation can improve the conditions above. Inspiratory muscle training (IMT) has been proven to enhance inspiratory muscle strength and endurance in patient with stable COPD. However, there is less research on whether IMT in addition to pulmonary rehabilitation after exacerbation can benefit inspiratory muscle function, functional exercise capacity and quality of life in patients with COPD. The purpose of this study is to examine the effects of IMT in addition to pulmonary rehabilitation on respiratory muscle function, functional exercise capacity and quality of life in patients with exacerbation of chronic obstructive pulmonary disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exacerbation Copd

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training combined pulmonary rehabilitation
Arm Type
Experimental
Arm Title
Sham inspiratory muscle training combined pulmonary rehabilitation
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
Intensity of inspiratory muscle training will be set at 30% of maximal inspiratory pressure. Subjects in intervention experimental group will perform 15 breaths per set, 6 sets per day on daily basis. The intervention will be last for 8 weeks.
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
Pulmonary rehabilitation consists of aerobic exercise training, strength training, and education related to airway clearance and drug utilization. All of subjects will receive 8-week pulmonary rehabilitation.
Primary Outcome Measure Information:
Title
Diaphragm muscle activation
Description
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of diaphragm muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. Diaphragm activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGDia).
Time Frame
10 minutes
Title
Sternocleidomastoid muscle activation
Description
The surface electromyography (EMG) signal was analyzed in the time domain, calculating root mean square (RMS) amplitude with a time constant of 30 mini seconds. A 1.5 seconds window of SCM muscle signals at peak pressure during maximal inspiratory pressure test were obtained and calculated as maximal effort. SCM activation were calculated using mean RMS values of each threshold loaded breathing test, and then normalized to maximal effort (%EMGSCM).
Time Frame
10 minutes
Secondary Outcome Measure Information:
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 fatigue.
Time Frame
10 minutes
Title
Functional exercise capacity
Description
Six-minute walking test will be performed to evaluate functional exercise capacity.
Time Frame
Considering time of test and recovery, it will be expected to take totally 10 minutes.
Title
Quality of life evaluation
Description
St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 20 years old diagnosed as exacerbation of COPD maximal inspiratory pressure (MIP) < 80 cmH2O 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 and Graduate Institute of Physical Therapy of National Taiwan University
City
Taipei
State/Province
Zhongzheng Dist
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation

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