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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Respiratory muscle training
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inpiratory and expiratory muscle training

Inspiratory muscle training

Arm Description

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

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

Outcomes

Primary Outcome Measures

MMSE
Mini-Mental State Examination

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2021
Last Updated
June 10, 2021
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04929990
Brief Title
The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment
Official Title
The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inpiratory and expiratory muscle training
Arm Type
Experimental
Arm Description
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
Arm Title
Inspiratory muscle training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Respiratory muscle training
Intervention Description
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)
Primary Outcome Measure Information:
Title
MMSE
Description
Mini-Mental State Examination
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Diaphragmatic thickness fraction
Description
Diaphragmatic thickness fraction on ultrasonography
Time Frame
8 weeks
Title
chronic obstructive pulmonary disease assessment test (CAT)
Description
questionnaire of dyspnea
Time Frame
8 weeks
Title
diffusing capacity of the lung for carbon monoxide (DLCO)
Description
diffusing capacity of the lung for carbon monoxide (DLCO) in pulmonary function test
Time Frame
8 weeks
Title
dead space fraction (Vd/Vt)
Description
dead space fraction (Vd/Vt) in cardiopulmonary function test
Time Frame
8 weeks
Title
the distance walked in 6 minutes
Description
the distance walked in 6 minutes
Time Frame
8 weeks
Title
Diaphragmatic excursion
Description
Diaphragmatic excursion on ultrasonography
Time Frame
8 weeks
Title
forced vital capacity
Description
forced vital capacity tested in pulmonary function test
Time Frame
8 weeks
Title
forced expiratory volume in 1 second
Description
forced expiratory volume in 1 second in pulmonary function test
Time Frame
8 weeks
Title
forced expiratory volume in 1 second divided by forced vital capacity
Description
forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test
Time Frame
8 weeks
Title
DLCO divided by alveolar volume (VA)
Description
DLCO divided by alveolar volume (VA) in pulmonary function test
Time Frame
8 weeks
Title
modified Medical Research Council (mMRC)
Description
questionnaire of dyspnea
Time Frame
8 weeks
Title
minute ventilation to carbon dioxide output (VE/VCO2) slope
Description
minute ventilation to carbon dioxide output (VE/VCO2) slope in cardiopulmonary function test
Time Frame
8 weeks
Title
the change of oxygen saturation in 6 minutes walking test
Description
the change of oxygen saturation in 6 minutes walking test
Time Frame
8 weeks
Title
the change of Borg scale in 6 minutes walking test
Description
the change of Borg scale in 6 minutes walking test
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Yang Cheng
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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