Improving Outcome Measures For Adult CF ACT Trials
Details
- Therapeutic approach
- Other
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001461
- Last updated
- 07/09/2016
Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults with CF
Study detailsThis is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.
Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.
Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.
Analysis will be based upon differences in outcome measures and in-between study days.
- Phase
- Not applicable
- Recruitment target
- 106
- CF sponsor
- National Institute for Health Research (UK)
- CF sponsor type
- Academic
Who can take part?
- Age range
- 16 years and older
- Including people
Diagnosis of CF (confirmed by standard criteria)
Sixteen years of age or over
Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)- Excluding people
Current infective exacerbation or reduction in lung function requiring therapeutic intervention
Current moderate haemoptysis (greater than streaking in the sputum)
Current dependency on positive pressure support with ACT
Previous history of spontaneous rib fractures
Pregnancy
Inability to give consent for treatment or measurement
Current participation in another interventional study
Current dependency upon non-invasive ventilation
Current dependency upon oxygen therapy
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