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临床试验/NCT03237962
NCT03237962已完成不适用

Effectiveness of High Flow Nasal Nannula on Exercise Endurance Among Patients During Pulmonary Rehabilitation

Chang Gung University4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
4
主要终点
Cardiac Output in L/min

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
55 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

High Flow Nasal Cannula

Experimental

Patients are randomly assigned into High flow nasal cannula group for the exercise training

干预措施: High Flow Nasal Cannula (Device)

Nasal Cannula

Experimental

Patients are randomly assigned into nasal cannula group for the exercise training.

干预措施: Nasal Cannula (Device)

结局指标

主要结局

Cardiac Output in L/min

时间窗: Changes from baseline to 6 weeks and 12 weeks

Heart rate and stroke volume will be combined to report cardiac output in L/min

次要结局

  • COPD Assessment Test (CAT)(Changes from baseline to 6 weeks and 12 weeks)
  • Modified Medical Research Council (mMRC) Dyspnea Scale(Changes from baseline to 6 weeks and 12 weeks)
  • The maximum inspiratory pressure in cmH2O(Changes from baseline to 6 weeks and 12 weeks)
  • The maximum expiratory pressure in cmH2O(Changes from baseline to 6 weeks and 12 weeks)
  • Tissue Saturation Index(Changes from baseline to 6 weeks and 12 weeks)
  • Total Hemoglobin(Changes from baseline to 6 weeks and 12 weeks)
  • Borg Scale(Changes from baseline to 6 weeks and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui-Ling Lin

Assistant Proffesor

Chang Gung University

研究点 (4)

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