A randomised controlled trial to investigate the use of high frequency airway oscillations as training to improve dyspnoea in COPD (TIDe)

niversity Hospitals of Leicester0 个研究点目标入组 104 人开始时间: 2017年10月19日最近更新: 2021年12月27日

适应症

试验速览

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31367635 protocol (added 02/08/2019) 2021 Results article in http://dx.doi.org/10.1136/thoraxjnl-2021-217072 (added 13/12/2021)

•1. Participant is willing and able to give informed consent for participation in the study
•2. Male or female, aged 40 years or above
•3. Confirmed diagnosed of COPD
•4. MRC Score of 2 or more on the conventional 1-5 scale. (walk slower than people of the same age on the level or stops for breath when walking at own pace on the level)
•5. Able to read and write in English
•For the sub studies ExPORt and CORe (added 23/05/2020):
•1. Participant is willing and able to give informed consent for participation in the study
•2. Referred to the study through a clinical service (pulmonary rehabilitation or admission with COVID-19)

•1. Significant disease (other than COPD) that could cause dyspnoea or exercise limitation
•2. Contraindications for exercise (unstable cardiovascular disease; hypertension etc, a full list is described by the American College of Sports Medicine and is routine deployed)
•3. Inability/unwillingness to use the device
•4. Contraindications to using HFAO device (including severe right heart failure with hypotension), current severe haemoptysis, ineffective cough, rib fractures, pregnancy, current or recent pneumothorax, epilepsy, current pulmonary embolism, oesophageal varices, recent thoracic, upper gastro-intestinal tract or facial surgery).
•5. Previously engaged in exercised based research or pulmonary rehab in the last 6 months
•6. Inability to secure informed consent
•7. Those unable to communicate in full English will be excluded as the user manual is only available in English
•8. Currently involved in exercise based research

发起方

niversity Hospitals of Leicester