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Inspiratory muscle training and cardiovascular autonomic changes in COPD patients

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220513001
Enrollment
72
Registered
2022-05-13
Start date
2022-05-11
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Home-based IMT will be performed daily using PowerBreathe device. Total eight week of IMT will be provided. The IMT group will start training at 40% of their initial PImax. The new PImax value will be
Experimental Other,No Intervention Other,No Intervention No treatment
Inspiratory muscle training (IMT),Control,Healthy subject

Sponsors

Mahidol University, Nakhon Pathom, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: COPD patients 1) COPD stage mild to very severe 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 ;Healthy subjects 1) aged between 55-80 years 2) normal chest x-ray 3) normal spirometry

Exclusion criteria

Exclusion criteria: COPD patients 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) Major depression or anxiety disorders 11) Participate in Cardiopulmonary rehabilitation ;Healthy subjects 1) Cardiac arrhythmias 2) Diabetes mellitus 3) Lung diseases 4) Neurological disorders 5) Cancer 6) Uncontrolled hypertension 7) Alcoholism 8) Current smoker 9) Mental disorder

Design outcomes

Primary

MeasureTime frame
Heart rate variability (HRV) Baseline (COPD and healthy subjects) and 8-week (Only COPD group) ECG monitor ,30:15 ratio Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Ewing test (Heart rate response to standing),Valsalva ratio Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Ewing test (Heart rate response to Valsalva),Max - Min HR Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Ewing test (Heart rate response to deep breathing),SBP change Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Ewing test (Blood pressure response to standing),Max DBP rise Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Ewing test (Blood pressure response to Handgrip exercise),Baroreflex sensitivity Baseline (COPD and healthy subjects) and 8-week (Only COPD group) ECG monitor and blood pressure,Blood pressure variability (BPV) Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Blood pressure

Secondary

MeasureTime frame
Spirometry Baseline (COPD and healthy subjects) and 8-week (Only COPD group) Pulmonary function test,Lung volume Baseline and after 8-week (Only COPD group) Pulmonary function test,6-minute walk distance Baseline (COPD and healthy subjects) and 8-week (Only COPD group) 6-minute walk test,Health status Baseline, 4th week, and after 8-week (Only COPD group) COPD Assessment Test and Clinical COPD Questionnaire,Depression and anxiety Baseline and after 8-week (Only COPD group) Thai Hospital anxiety and depression scale,Dyspnea assessed by mMRC Baseline, 4 week, and after 8-week (Only COPD group) mMRC,Dyspnea assessed by BDI-TDI Baseline for BDI and after 8-week for TDI (Only COPD group) BDI-TDI,Physical activity Baseline and after 8-week (Only COPD group) Thai International Physical Activity Questionnaire,Inspiratory muscle strength in IMT group PImax: Baseline, every week of IMT, and after 8-week (Only COPD group) PImax,Inspiratory muscle strength in control group Baseline and after 8-week (Only COPD group) PImax,Expiratory muscle strength in both groups Baseline and after 8-week (Only COPD group) PEmax,Inspiratory muscle endurance Baseline and after 8-week (Only COPD group) Constant load testing,Respiratory resistance and reactance Baseline and after 8-week (Only COPD group) Impulse oscillometry system (IOS) technique,Gas exchange Baseline and after 8-week (Only COPD group) The diffusing capacity of lung for carbon monoxide (DLCO)

Countries

Thailand

Contacts

Public ContactPairoj Suraprapapich

Mahidol University

pairoj.sur@mahidol.ac.th0933971414

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026