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

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
• Conditions: Chronic Obstructive Pulmonary Disease; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Respiratory muscle training

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

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: Respiratory muscle training; 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)
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	Behavioral: Respiratory muscle training; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Study Director: Yuan-Yang Cheng, Taichung Veterans General Hospital

Study record dates

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: Mental Disorders; Respiratory Tract Diseases; Lung Diseases; Neurocognitive Disorders; Cognition Disorders; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction
• 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