Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation
NCT number | NCT03237962 |
Other study ID # | NMRPD1F0731 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | August 2018 |
Verified date | February 2019 |
Source | Chang Gung University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to compare and assess the immediate and long-term
effects on pulmonary rehabilitation training with the usage of HFNC or conventional oxygen
therapy device.
The hypotheses was, with high flow nasal cannula usage while exercising, the physiological
outcome measurements would be better than conventional oxygen therapy device. Also, the usage
of HFNC can immediately increase patient's exercising endurance and decrease dyspnea caused
by exercising.
Status | Completed |
Enrollment | 32 |
Est. completion date | August 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Age > 55 years - COPD patients with confirmed pulmonary function test results of FEV1<70% - Regular follow-up at the pulmonary medicine clinic - Stable condition without acute exacerbation - No pulmonary rehabilitation training within a year - None oxygen usage at home - No smoking history or quit smoking - Inform consent signed Exclusion Criteria: - Fever (Body Temperature >37.5°C) - Acute infection symptoms - Unstable cardiovascular status (Eg: Blood pressure >150/100 mmHg after medication usage, angina pectoris, or abnormal ECG) - Activity restrictions due to orthopedic or neuromuscular disease |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan | |
Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Output in L/min | Heart rate and stroke volume will be combined to report cardiac output in L/min | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | COPD Assessment Test (CAT) | Questionnaire designed to evaluate COPD patient's quality of life. | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | Modified Medical Research Council (mMRC) Dyspnea Scale | Scale to determine the breathlessness of COPD patients during their daily activity | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | The maximum inspiratory pressure in cmH2O | The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | The maximum expiratory pressure in cmH2O | The maximum expiratory pressure in cmH2O | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | Tissue Saturation Index | Tissue Saturation Index measured by near-Infrared spectroscopy | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | Total Hemoglobin | Total Hemoglobin measured by near-Infrared spectroscopy | Changes from baseline to 6 weeks and 12 weeks | |
Secondary | Borg Scale | Scale examining the level of dyspnea or the shortness of breath during exercise | Changes from baseline to 6 weeks and 12 weeks |
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