The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment

Study Overview
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Brief Summary
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Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects

Detailed Description
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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.

Official Title
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The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment

Conditions
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Chronic Obstructive Pulmonary Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Respiratory muscle training


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inpiratory and expiratory muscle training<br>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 | Behavioral: Respiratory muscle training<br>* 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)<br>|
| Active Comparator: Inspiratory muscle training<br>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 | Behavioral: Respiratory muscle training<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE | Mini-Mental State Examination | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic thickness fraction | Diaphragmatic thickness fraction on ultrasonography | 8 weeks | 
| chronic obstructive pulmonary disease assessment test (CAT) | questionnaire of dyspnea | 8 weeks | 
| diffusing capacity of the lung for carbon monoxide (DLCO) | diffusing capacity of the lung for carbon monoxide (DLCO) in pulmonary function test | 8 weeks | 
| dead space fraction (Vd/Vt) | dead space fraction (Vd/Vt) in cardiopulmonary function test | 8 weeks | 
| the distance walked in 6 minutes | the distance walked in 6 minutes | 8 weeks | 
| Diaphragmatic excursion | Diaphragmatic excursion on ultrasonography | 8 weeks | 
| forced vital capacity | forced vital capacity tested in pulmonary function test | 8 weeks | 
| forced expiratory volume in 1 second | forced expiratory volume in 1 second in pulmonary function test | 8 weeks | 
| forced expiratory volume in 1 second divided by forced vital capacity | forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test | 8 weeks | 
| DLCO divided by alveolar volume (VA) | DLCO divided by alveolar volume (VA) in pulmonary function test | 8 weeks | 
| modified Medical Research Council (mMRC) | questionnaire of dyspnea | 8 weeks | 
| minute ventilation to carbon dioxide output (VE/VCO2) slope | minute ventilation to carbon dioxide output (VE/VCO2) slope in cardiopulmonary function test | 8 weeks | 
| the change of oxygen saturation in 6 minutes walking test | the change of oxygen saturation in 6 minutes walking test | 8 weeks | 
| the change of Borg scale in 6 minutes walking test | the change of Borg scale in 6 minutes walking test | 8 weeks |