Airway Clearance by Exercising in mild Cystic Fibrosis (ACE-CF): a feasibility study.
- Conditions
- Cystic FibrosisHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12615001361594
- Lead Sponsor
- athan Ward
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Diagnosis of cystic fibrosis confirmed by positive sweat or identification of 2 CF-causing genetic mutations; FEV1 > 69% at baseline; an active patient of the Royal Adelaide CF Service; clinically stable (no new medications for 4 weeks, FEV1 within 10% of most recent value at time of baseline, upper respiratory tract infection free for 2 weeks)
Lacking capacity to provide informed consent; post-lung transplant; unwilling to participate; current participation in another interventional study; pregnant; inability to understand written English; pneumothorax in the last 6 months haemotysis > 20mls in the 4 weeks prior to baseline assessment; positive culture for Burkholderia cepacia within the last year; active treatment for Non-Tuberculosis Mycobacteria; presence of a condition or abnormality that, in the opinion of the treating CF physician, compromises the safety of the patient or would otherwise make them unsuitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility, by the ability to recruit at least 30% of identified eligible patients[End of 12 month recruitment period];Feasibility, by at least 80% of participants being adherent with the protocol at the end of the wash-in period and therefore eligible for randomisation[End of 4 week wash-in period];Feasibility, by at least 80% of randomised participants completing the intervention phase and follow-up measurements.[End of 3 month intervention period]
- Secondary Outcome Measures
Name Time Method