Clinical trial NCT03237962: High Flow Nasal Cannula During Pulmonary Rehabilitation
Official title: Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: High flow nasal cannula
Pulmonary rehab
Pulmonary rehabilitation
Nasal cannula
Exercise endurance
Oxygen Therapy
COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Output in L/min
timeFrame: Changes from baseline to 6 weeks and 12 weeks
Secondary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: The maximum inspiratory pressure in cmH2O
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: The maximum expiratory pressure in cmH2O
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: Tissue Saturation Index
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: Total Hemoglobin
timeFrame: Changes from baseline to 6 weeks and 12 weeks
measure: Borg Scale
timeFrame: Changes from baseline to 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Hui-Ling Lin, MSc
role: PRINCIPAL_INVESTIGATOR
References: