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An eight week pilot study to investigate the effect of oscillation device on breathlessness in patients with chronic obstructive pulmonary disease

An eight week pilot study to investigate the effect of High-Frequency Airway Oscillation on breathlessness in patients with Chronic Obstructive Pulmonary Disease: a single arm interventional trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81979106
Enrollment
24
Registered
2016-05-24
Start date
2016-05-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease

Interventions

An Aerosure device will be issued to all participants in the trial. This is a high frequency airway oscillatory device to be used up to three times per day in order to gain an insight into the trainin

Sponsors

University Hospitals of Leicester
Lead Sponsor

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 3 or more. (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

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

Design outcomes

Primary

MeasureTime frame
Breathlessness at baseline and after 8 week of HFAO, measured using the Chronic respiratory Questionnaire (CRQ) Dyspnoea domain

Secondary

MeasureTime frame
1. Exercise endurance at baseline and after 8 week of HFAO, measured using the incremental and endurance shuttle walk test 2. Quality of life at baseline and after 8 week of HFAO, measured using the CRQ fatigue, mastery and emotion domains, COPD Assessment Test (CAT), Leicester Cough Questionnaire, London Chest Activities of Daily Living Questionnaire 3. Breathlessness pre and post exercise testing at baseline and 8 weeks of HFAO, measured using the Borg Breathlessness scale 4. Anxiety and depression at baseline and after 8 week of HFAO, measured using the Hospital Anxiety and Depression Scale 5. Inspiratory and expiratory muscle strength at baseline and after 8 week of HFAO, measured using lung function testing 6. Patient experience of trial measured in dissemination event discussion at the end of the trial (estimated October/November 2016) 7. Adherence of device use measured using daily diaries

Countries

United Kingdom

Contacts

Public ContactEnya Daynes
enya.daynes@uhl-tr.nhs.uk01162502758

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026