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Completed

NCT Number: NCT04929990

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Cognition Disorders Cognitive Dysfunction Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory muscle training

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)

Primary outcomes

  1. MMSE

    Time frame: 8 weeks

    Mini-Mental State Examination

Secondary outcomes

  1. Diaphragmatic thickness fraction

    Time frame: 8 weeks

    Diaphragmatic thickness fraction on ultrasonography

  2. chronic obstructive pulmonary disease assessment test (CAT)

    Time frame: 8 weeks

    questionnaire of dyspnea

  3. diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: 8 weeks

    diffusing capacity of the lung for carbon monoxide (DLCO) in pulmonary function test

  4. dead space fraction (Vd/Vt)

    Time frame: 8 weeks

    dead space fraction (Vd/Vt) in cardiopulmonary function test

  5. the distance walked in 6 minutes

    Time frame: 8 weeks

    the distance walked in 6 minutes

  6. Diaphragmatic excursion

    Time frame: 8 weeks

    Diaphragmatic excursion on ultrasonography

  7. forced vital capacity

    Time frame: 8 weeks

    forced vital capacity tested in pulmonary function test

  8. forced expiratory volume in 1 second

    Time frame: 8 weeks

    forced expiratory volume in 1 second in pulmonary function test

  9. forced expiratory volume in 1 second divided by forced vital capacity

    Time frame: 8 weeks

    forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test

  10. DLCO divided by alveolar volume (VA)

    Time frame: 8 weeks

    DLCO divided by alveolar volume (VA) in pulmonary function test

  11. modified Medical Research Council (mMRC)

    Time frame: 8 weeks

    questionnaire of dyspnea

  12. minute ventilation to carbon dioxide output (VE/VCO2) slope

    Time frame: 8 weeks

    minute ventilation to carbon dioxide output (VE/VCO2) slope in cardiopulmonary function test

  13. the change of oxygen saturation in 6 minutes walking test

    Time frame: 8 weeks

    the change of oxygen saturation in 6 minutes walking test

  14. the change of Borg scale in 6 minutes walking test

    Time frame: 8 weeks

    the change of Borg scale in 6 minutes walking test

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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