Improving Outcome Measures For Adult CF ACT Trials

Details

Therapeutic category
Other
Trial status
Open to recruitment Participating Centres
Phase
Not Applicable

Full title

Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults with CF

This 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.
Trial Reference Number
72930
Trial type
Non-medication
Intervention
Study visit 1: Participants complete the airway clearance technique the Active Cycle of Breathing (ACBT) for a maximum of 60 minutes. ACBT is a breathing technique which includes normal relaxed breathing, deep breathing and huffs to clear sputum. Participants will be fully taught this by a specialist CF physiotherapist.

Study visit 2: Participants undergo up to 60 minutes of rest, in which they sit in a comfortable position and can complete any tasks which are non-active (such as reading/using internet etc.)
Recruitment target
106
Last edited date
07/09/2016
CF sponsor
National Institute for Health Research (UK)
CF sponsor type
Academic

Who can take part?

Age
16+
Top inclusion criteria
  • 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)
Top exclusion criteria
  • 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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