Clinical trial NCT04929990: The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment
Official title: The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Mild Cognitive Impairment
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MMSE
timeFrame: 8 weeks
Secondary outcomes:
measure: Diaphragmatic thickness fraction
timeFrame: 8 weeks
measure: chronic obstructive pulmonary disease assessment test (CAT)
timeFrame: 8 weeks
measure: diffusing capacity of the lung for carbon monoxide (DLCO)
timeFrame: 8 weeks
measure: dead space fraction (Vd/Vt)
timeFrame: 8 weeks
measure: the distance walked in 6 minutes
timeFrame: 8 weeks
measure: Diaphragmatic excursion
timeFrame: 8 weeks
measure: forced vital capacity
timeFrame: 8 weeks
measure: forced expiratory volume in 1 second
timeFrame: 8 weeks
measure: forced expiratory volume in 1 second divided by forced vital capacity
timeFrame: 8 weeks
measure: DLCO divided by alveolar volume (VA)
timeFrame: 8 weeks
measure: modified Medical Research Council (mMRC)
timeFrame: 8 weeks
measure: minute ventilation to carbon dioxide output (VE/VCO2) slope
timeFrame: 8 weeks
measure: the change of oxygen saturation in 6 minutes walking test
timeFrame: 8 weeks
measure: the change of Borg scale in 6 minutes walking test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Yuan-Yang Cheng
role: STUDY_DIRECTOR
References: