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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Mild Cognitive Impairment
• Interventions: Behavioral: Respiratory muscle training

• Registration Number: NCT04929990
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2018-08-07
• Primary Completion: 2021-04-06
• Status Verified: 2021-06
• Study Completion: 2021-06-02
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-10
• Last Update Submitted: 2021-06-10
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpiratory and expiratory muscle training	Respiratory 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
Inspiratory muscle training	Respiratory 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

Primary Outcome Measures

Name	Time	Method
MMSE	8 weeks	Mini-Mental State Examination

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan