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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929990
• Other study ID #: CF18259A
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: June 2, 2021

Study information

• Verified date: June 2021
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Cognitive Dysfunction
• Lung Diseases, Obstructive
• Mild Cognitive Impairment
• Pulmonary Disease, Chronic Obstructive

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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