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Effect of inspiratory muscle training on cardiovascular autonomic functions in chronic obstructive pulmonary disease patients

Phase 2
Recruiting
Conditions
Chronic obstructive pulmonary disease (COPD)
Cardiovascular autonomic functions, COPD, Inspiratory muscle training
Registration Number
TCTR20220513001
Lead Sponsor
Mahidol University, Nakhon Pathom, Thailand
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
48
Inclusion Criteria

1) COPD stage mild to very severe that defined by GOLD 2021 guideline
2) Aged between 40-80 years
3) No exacerbation within 1 month prior to the study
4) No change in pharmacological treatment within 1 month prior to the study
5) Good ability to communicate and follow instruction

Exclusion Criteria

1) Pneumothorax
2) A collapsed lung due to a traumatic injury or lung disease
3) Large bullae on chest radiograph
4) History of rib fracture
5) History of recent lung surgery within 6 months
6) Other lung disease that affect on pulmonary function such as asthma, pulmonary fibrosis, pneumonia from COVID-19
7) Progressive neurological or neuromuscular disorders
8) Cardiac arrhythmias
9) Alcoholism
10) Alzheimer's disease (MoCA score < 16 within 1 year before study)
11) Untreated major depression or anxiety disorders
12) Participate in Cardiopulmonary rehabilitation

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Heart rate variability (HRV) Baseline and after 8-week ECG monitor ,30:15 ratio Baseline and after 8-week Ewing test (Heart rate response to standing),Valsalva ratio Baseline and after 8-week Ewing test (Heart rate response to Valsalva),Max - Min HR Baseline and after 8-week Ewing test (Heart rate response to deep breathing),SBP change Baseline and after 8-week Ewing test (Blood pressure response to standing),Max DBP rise Baseline and after 8-week Ewing test (Blood pressure response to Handgrip exercise),Baroreflex sensitivity Baseline and after 8-week ECG monitor and blood pressure
Secondary Outcome Measures
NameTimeMethod
Spirometry Baseline and after 8-week Pulmonary function test,Lung volume Baseline and after 8-week Pulmonary function test,6-minute walk distance Baseline and after 8-week 6-minute walk test,Quality of life Baseline, 4th week, and after 8-week COPD Assessment Test and Clinical COPD Questionnaire,Depression and anxiety Baseline and after 8-week Thai Hospital anxiety and depression scale,Dyspnea assessed by mMRC Baseline, 4 week, and after 8-week mMRC,Dyspnea assessed by BDI-TDI Baseline for BDI and after 8-week for TDI BDI-TDI,Physical activity Baseline and after 8-week Thai International Physical Activity Questionnaire,Inspiratory muscle strength in IMT group PImax: Baseline, every week of IMT, and after 8-week PImax,Inspiratory muscle strength in control group Baseline and after 8-week PImax,Expiratory muscle strength in both groups Baseline and after 8-week PEmax,Inspiratory muscle endurance Baseline and after 8-week Constant load testing
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