Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Current interventions as of 23/05/2020:
For the main TIDe study participants are randomised by a computer-generated system to one of two groups:
1. Aerosure device
2. Sham device
This will be a blind
Sponsors
University Hospitals of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnoea is measured using the Dyspnoea domain of the Chronic Respiratory Questionnaire and the COPD assessment test at baseline and after 8 weeks of the intervention (typically 9 weeks later) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/02/2019: All outcome measures are performed at baseline and after 8 weeks of the intervention (typically 9 weeks later): 1. Respiratory muscle strength is measured via maximal mouth inspiratory muscle strength test and maximal mouth expiratory muscle strength test 2. Exercise capacity is measured via the incremental shuttle walking test and the endurance shuttle walking test 3. Health-related quality of life is measured via the Chronic Respiratory Questionnaire, COPD assessment test, Leicester Cough Questionnaire, London Activity of Daily Living Questionnaire and the Hospital Anxiety and Depression Score 4. Activity is measured using an activity monitor prior to the intervention and on week 7 of the intervention 5. Lung Clearance Index measured via a Multiple Breath Washout. Previous secondary outcome measures: All outcome measures are performed at baseline and after 8 weeks of the intervention (typically 9 weeks later): 1. Respiratory muscle strength is measured via maximal mouth inspiratory muscle strength test and maximal mouth expiratory muscle strength test 2. Exercise capacity is measured via the incremental shuttle walking test and the endurance shuttle walking test 3. Health-related quality of life is measured via the Chronic Respiratory Questionnaire, COPD assessment test, Leicester Cough Questionnaire, London Activity of Daily Living Questionnaire and the Hospital Anxiety and Depression Score 4. Activity is measured using an activity monitor prior to the intervention and on week 7 of the intervention | — |
Countries
England, United Kingdom
Contacts
Public ContactEnya Daynes
Outcome results
None listed