The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment
June 10, 2021 updated by: Taichung Veterans General Hospital
The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment
Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with COPD and MCI were recruited, and were randomly assigned to the experimental group and the control group.
The experimental group consisted of EMT and IMT for a total of 8 weeks, while the control group received IMT only.
Outcomes measured and compared in this cohort were diaphragmatic thickness fraction and excursion examined by ultrasound, the dyspnea score of modified Medical Research Council (mMRC), the cognitive score of Mini-Mental State Examination (MMSE), and the score of COPD Assessment Test (CAT).
In addition, the pulmonary function test, the cardiopulmonary exercise test, and the physiology performance of six minute walking test were also obtained.
We also analyzed the difference of each parameters before and after training in each patient.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.7.
- 2. The score of Mini-Mental State Examination (MMSE) being between 23 and 27
Exclusion Criteria:
- 1. Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
- 2. Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
- 3. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
- 4. Having Body Mass Index more than 30
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Inpiratory and expiratory muscle training
The initial intensity of training was set on 30% of the MIP and MEP for inspiratory and expiratory muscle training, respectively.
The intensity was adjusted to add 5% of resistance each week
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Inspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks.
Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan)
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Active Comparator: Inspiratory muscle training
The initial resistance of the breathing trainer was also set on 30% of MIP, and the following adjustments were also in accordance to the protocol of the experimental group
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Inspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks.
Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MMSE
Time Frame: 8 weeks
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Mini-Mental State Examination
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diaphragmatic thickness fraction
Time Frame: 8 weeks
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Diaphragmatic thickness fraction on ultrasonography
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8 weeks
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chronic obstructive pulmonary disease assessment test (CAT)
Time Frame: 8 weeks
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questionnaire of dyspnea
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8 weeks
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diffusing capacity of the lung for carbon monoxide (DLCO)
Time Frame: 8 weeks
|
diffusing capacity of the lung for carbon monoxide (DLCO) in pulmonary function test
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8 weeks
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dead space fraction (Vd/Vt)
Time Frame: 8 weeks
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dead space fraction (Vd/Vt) in cardiopulmonary function test
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8 weeks
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the distance walked in 6 minutes
Time Frame: 8 weeks
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the distance walked in 6 minutes
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8 weeks
|
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Diaphragmatic excursion
Time Frame: 8 weeks
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Diaphragmatic excursion on ultrasonography
|
8 weeks
|
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forced vital capacity
Time Frame: 8 weeks
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forced vital capacity tested in pulmonary function test
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8 weeks
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forced expiratory volume in 1 second
Time Frame: 8 weeks
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forced expiratory volume in 1 second in pulmonary function test
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8 weeks
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forced expiratory volume in 1 second divided by forced vital capacity
Time Frame: 8 weeks
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forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test
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8 weeks
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DLCO divided by alveolar volume (VA)
Time Frame: 8 weeks
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DLCO divided by alveolar volume (VA) in pulmonary function test
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8 weeks
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modified Medical Research Council (mMRC)
Time Frame: 8 weeks
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questionnaire of dyspnea
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8 weeks
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minute ventilation to carbon dioxide output (VE/VCO2) slope
Time Frame: 8 weeks
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minute ventilation to carbon dioxide output (VE/VCO2) slope in cardiopulmonary function test
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8 weeks
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the change of oxygen saturation in 6 minutes walking test
Time Frame: 8 weeks
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the change of oxygen saturation in 6 minutes walking test
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8 weeks
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the change of Borg scale in 6 minutes walking test
Time Frame: 8 weeks
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the change of Borg scale in 6 minutes walking test
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yuan-Yang Cheng, Taichung Veterans General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Actual)
April 6, 2021
Study Completion (Actual)
June 2, 2021
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
June 10, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
June 18, 2021
Last Update Submitted That Met QC Criteria
June 10, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF18259A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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