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

NCT04802096 | Completed

• 1 other identifier: 202012102RINC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Exacerbation Copd

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The mean median frequency of diaphragm and sternocleidomastoid muscle

  10 minutes

• Functional exercise capacity

  Considering time of test and recovery, it will be expected to take totally 10 minutes.

• Quality of life evaluation

  10 minutes

Study Arms (2)

Inspiratory muscle training combined pulmonary rehabilitation

EXPERIMENTAL

Other: inspiratory muscle training; Other: pulmonary rehabilitation

Sham inspiratory muscle training combined pulmonary rehabilitation

SHAM COMPARATOR

Other: pulmonary rehabilitation

Interventions

inspiratory muscle training OTHER

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.

Inspiratory muscle training combined pulmonary rehabilitation

pulmonary rehabilitation OTHER

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.

Inspiratory muscle training combined pulmonary rehabilitation; Sham inspiratory muscle training combined pulmonary rehabilitation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and Graduate Institute of Physical Therapy of National Taiwan University

Taipei, Zhongzheng Dist, 100, Taiwan

Location

Related Publications (1)

• Huang WY, Lee CT, Chien JY, Hsu M, Wang LY. Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease Exacerbations: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 May 1;104(5):458-464. doi: 10.1097/PHM.0000000000002654. Epub 2024 Nov 11.

  PMID: 39774113 DERIVED

Study Officials

• Li-Ying Wang, PhD

  National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: March 15, 2021
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

TW (1)