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

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.

Study Overview

• Status: Completed
• Conditions: Exacerbation Copd
• Intervention / Treatment: Other: inspiratory muscle training; Other: pulmonary rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng Dist
    • Taipei, Zhongzheng Dist, Taiwan, 100
      • School and Graduate Institute of Physical Therapy of National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Inspiratory muscle training combined pulmonary rehabilitation	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.; Other: 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.
SHAM_COMPARATOR: Sham inspiratory muscle training combined pulmonary rehabilitation	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
Quality of life evaluation	St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.	10 minutes

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2021
• Primary Completion (ACTUAL): September 16, 2022
• Study Completion (ACTUAL): September 16, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 202012102RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No