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

NCT ID: NCT04929990

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2021-06-02

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.

Conditions

Chronic Obstructive Pulmonary Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Respiratory muscle training

Intervention Type: BEHAVIORAL

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)

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

Group Type: ACTIVE_COMPARATOR

Respiratory muscle training

Intervention Type: BEHAVIORAL

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)

Interventions

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)

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan-Yang Cheng

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CF18259A

Identifier Type: -

Identifier Source: org_study_id