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

T

Taichung Veterans General Hospital

Status

Completed

Conditions

Mild Cognitive Impairment
Chronic Obstructive Pulmonary Disease

Treatments

Behavioral: Respiratory muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT04929990
CF18259A

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Volunteers

No 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.
    1. 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.
    1. 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.
    1. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
    1. Having Body Mass Index more than 30

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Inpiratory and expiratory muscle training
Experimental group
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
Treatment:
Behavioral: Respiratory muscle training
Inspiratory muscle training
Active Comparator group
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
Treatment:
Behavioral: Respiratory muscle training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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