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

Exacerbation Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802096
• Other study ID #: 202012102RINC
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: February 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exacerbation Copd
• Respiratory Aspiration

Intervention

Other:
• inspiratory muscle training
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.
• pulmonary rehabilitation
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.

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy of National Taiwan University	Taipei	Zhongzheng Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 minutes
Primary	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).	10 minutes
Secondary	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.	10 minutes
Secondary	Functional exercise capacity	Six-minute walking test will be performed to evaluate functional exercise capacity.	Considering time of test and recovery, it will be expected to take totally 10 minutes.
Secondary	Quality of life evaluation	St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.	10 minutes