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Clinical Trials/NCT04929990
NCT04929990
Completed
Not Applicable

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

Taichung Veterans General Hospital1 site in 1 country70 target enrollmentAugust 7, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Taichung Veterans General Hospital
Enrollment
70
Locations
1
Primary Endpoint
MMSE
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 7, 2018
End Date
June 2, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.
  • The score of Mini-Mental State Examination (MMSE) being between 23 and 27

Exclusion Criteria

  • Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
  • 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.
  • Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
  • Having Body Mass Index more than 30

Outcomes

Primary Outcomes

MMSE

Time Frame: 8 weeks

Mini-Mental State Examination

Secondary Outcomes

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

Study Sites (1)

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