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

Not Applicable

Completed

• Conditions: Exacerbation Copd
• Interventions: Other: pulmonary rehabilitation; Other: inspiratory muscle training

• Registration Number: NCT04802096
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham inspiratory muscle training combined pulmonary rehabilitation	pulmonary rehabilitation	-
Inspiratory muscle training combined pulmonary rehabilitation	pulmonary rehabilitation	-
Inspiratory muscle training combined pulmonary rehabilitation	inspiratory muscle training	-

Primary Outcome Measures

Name	Time	Method
Sternocleidomastoid muscle activation	10 minutes	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).
Diaphragm muscle activation	10 minutes	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).

Secondary Outcome Measures

Name	Time	Method
The mean median frequency of diaphragm and sternocleidomastoid muscle	10 minutes	The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigue.
Quality of life evaluation	10 minutes	St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.
Functional exercise capacity	Considering time of test and recovery, it will be expected to take totally 10 minutes.	Six-minute walking test will be performed to evaluate functional exercise capacity.

Trial Locations

Locations (1)

School and Graduate Institute of Physical Therapy of National Taiwan University; 🇨🇳 Taipei, Zhongzheng Dist, Taiwan