Training to Improve Dyspnoea
Research type
Research Study
Full title
A Randomised Controlled Trial to Investigate the Use of High Frequency Airway Oscillations as Training to Relieve Dyspnoea in COPD.
IRAS ID
220947
Contact name
Sally Singh
Contact email
Sponsor organisation
University Hospitals of Leicester
Duration of Study in the UK
3 years, 8 months, 8 days
Research summary
Research Summary
This is an investigative randomised controlled trial of a High Frequencey Airway Oscillation (HFAO) device compared with a sham to assess the impact on dyspnoea on patients with Chronic Obstructive Pulmonary Disease (COPD). Participants will receive either an active HFAO device or a sham and use three times a day, for a minimum of 5 minutes each time for 8 weeks. It is hypothesised that the active device will reduce dyspnoea and improve respiratory muscle strength and exercise capacity. [COVID-19 amendment 28/04/2020] This amendment is for the addition of a sub study for the assessment of post-covid rehabilitation needs. This will be a multiple phase trial. Phase one will be collecting information about patient needs post admission for COVID. This will require one telephone call where consent will be gained and assessment of demographics, work status and return to work information and Health Related Quality of Life questionnaires. Participants will be required to give\nverbal consent in the interest of minimising exposure and trips to hospital and reducing risks on staff. Patients will be given the opportunity to opt out of the data collection. Patient medical notes and discharge letters will be screened to identify information of their hospital stay including length of stay and ventilation requirements. The results from this study will inform further phases of the research which will develop rehabilitation interventions based on the identified needs of the patients. Phone calls are made as part of routine clinical care and therefore these patients will not be asked to do any extra contacts but rather data will be collected during this routine contact. COVID 19 amendment 28/04/2020 This amendment is for the addition of a sub study for the assessment of post-covid rehabilitation needs. This will be a multiple phase trial. Phase one will be collecting information about patient needs post admission for COVID. This will require one telephone call where consent will be gained and assessment of demographics, work status and return to work information and Health Related Quality of Life questionnaires. Participants will be required to give verbal consent in the interest of minimising exposure and trips to hospital and reducing risks on staff. Patients will be given the opportunity to opt out of the data collection. Patient medical notes and discharge letters will be screened to identify information of their hospital stay including length of stay and ventilation requirements. The results from this study will inform further phases of the research which will develop rehabilitation interventions based on the identified needs of the patients. Phone calls are made as part of routine clinical care and therefore these patients will not be asked to do any extra contacts but rather data will be collected during this routine contact.
Summary of Results
This study compared a device (Aerosure) to a dummy device in patients with COPD and we had 96 patients complete the study. The use of the Aerosure was not better than the sham device in reducing breathlessness, or improving quality of life. We found that both patients who had the device and those having the dummy device, improved their breathlessness over the eight weeks study period.
The Aerosure did demonstrate improvements in muscle strength of the breathing muscles which the sham did not. This means that those using the Aerosure had stronger breathing muscles after using the device but this did not convert into benefits for breathing or quality of life.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0156
Date of REC Opinion
7 Jun 2017
REC opinion
Further Information Favourable Opinion