Chronic Obstructive Pulmonary Disease
Conditions
Keywords
High flow nasal cannula, Pulmonary rehab, Pulmonary rehabilitation, Nasal cannula, Exercise endurance, Oxygen Therapy, COPD, Chronic Obstructive Pulmonary Disease
Brief summary
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.
Detailed description
Pulmonary Rehabilitation is one of the most recommended methods to improve the muscle function of COPD patients. By exercise training, even patients with severe COPD can increase muscle strength, improve skeletal muscle function and enhance exercise endurance. Due to improvements in exercise endurance, when exercising at a higher intensity, ventilation support and dynamic hyperinflation would slightly decrease which leads to less dyspnea during exercise. Continuously exercising can also increase the motivation to exercise, reduce mood irritability and psychological burden caused by symptoms. By exercising, patient's health status can be both improved physically and mentally. High Flow Nasal Cannula (HFNC) is a non-invasive ventilatory device that provides stable oxygen concentration, temperature (37℃) and humidity (Relative Humidity: 100%). Humidity provided by the HFNC reduces irritation caused by the high flow, which leads to the increase of user's tolerance with the device. With the half-closed system formed by a nasal prong, when the high flow enters the upper airway, continue positive airway pressure would be formed. Subjects enrolled into this study are required to join a 6-week pulmonary rehabilitation program. Before starting the program, subjects were randomly assigned to high flow nasal cannula group and conventional oxygen therapy group. When exercising, the nasal cannula group would receive an oxygen flow of 3 - 5L to maintain SpO2\>90% and the HFNC group with high flow setting of 45-50Lpm along with oxygen flow of 3-5L also to maintain SpO2\>90%. When joining the pulmonary rehabilitation program, patients are required to exercise for approximately 45 minutes per session. When exercising, changes in the degree of dyspnea, quadriceps blood flow and hemodynamics are assessed. After 6-week of the exercise training, all the parameters will again be assessed and compared to the primary data that was collected from the beginning of the program.
Interventions
DEVICEHigh Flow Nasal Cannula
High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.
DEVICENasal Cannula
Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.
Sponsors
Chang Gung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output in L/min | Changes from baseline to 6 weeks and 12 weeks | Heart rate and stroke volume will be combined to report cardiac output in L/min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum expiratory pressure in cmH2O | Changes from baseline to 6 weeks and 12 weeks | The maximum expiratory pressure in cmH2O |
| Modified Medical Research Council (mMRC) Dyspnea Scale | Changes from baseline to 6 weeks and 12 weeks | Scale to determine the breathlessness of COPD patients during their daily activity |
| COPD Assessment Test (CAT) | Changes from baseline to 6 weeks and 12 weeks | Questionnaire designed to evaluate COPD patient's quality of life. |
| The maximum inspiratory pressure in cmH2O | Changes from baseline to 6 weeks and 12 weeks | The maximum inspiratory pressure in cmH2O represents the strength of the abdominal and expiratory muscles |
| Total Hemoglobin | Changes from baseline to 6 weeks and 12 weeks | Total Hemoglobin measured by near-Infrared spectroscopy |
| Borg Scale | Changes from baseline to 6 weeks and 12 weeks | Scale examining the level of dyspnea or the shortness of breath during exercise |
| Tissue Saturation Index | Changes from baseline to 6 weeks and 12 weeks | Tissue Saturation Index measured by near-Infrared spectroscopy |
Countries
Taiwan
Outcome results
None listed