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

NCT ID: NCT04802096

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-09-16

Brief Summary

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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

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Conditions

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Exacerbation Copd

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Inspiratory muscle training combined pulmonary rehabilitation

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type 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.

pulmonary rehabilitation

Intervention Type 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.

Sham inspiratory muscle training combined pulmonary rehabilitation

Group Type SHAM_COMPARATOR

pulmonary rehabilitation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Ying Wang, PhD

Role: STUDY_CHAIR

National Taiwan University

Locations

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School and Graduate Institute of Physical Therapy of National Taiwan University

Taipei, Zhongzheng Dist, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 39774113 (View on PubMed)

Other Identifiers

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202012102RINC

Identifier Type: -

Identifier Source: org_study_id

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