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

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ClinicalTrials.gov Identifier: NCT04802096
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exacerbation Copd Other: inspiratory muscle training Other: pulmonary rehabilitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Diaphragm muscle activation [ Time Frame: 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).

  2. Sternocleidomastoid muscle activation [ Time Frame: 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).


Secondary Outcome Measures :
  1. The mean median frequency of diaphragm and sternocleidomastoid muscle [ Time Frame: 10 minutes ]
    The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigue.

  2. Functional exercise capacity [ Time Frame: 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.

  3. Quality of life evaluation [ Time Frame: 10 minutes ]
    St. George's Respiratory Questionnaire and COPD assessment test will be used to evaluate quality of life.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802096


Contacts
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Contact: Wei-Yu Huang +886972308260 r08428013@ntu.edu.tw
Contact: Wei-Yu Huang +886972308260 wyhincplab@gmail.com

Locations
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Taiwan
School and Graduate Institute of Physical Therapy of National Taiwan University Recruiting
Taipei, Zhongzheng Dist, Taiwan, 100
Contact: Li-Ying Wang, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Li-Ying Wang, PhD National Taiwan University
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04802096    
Other Study ID Numbers: 202012102RINC
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes