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Airway Clearance by Exercising in mild Cystic Fibrosis (ACE-CF): a feasibility study.

Exercise alone versus exercise and positive expiratory pressure as a form of airway secretion clearance in adults with mild cystic fibrosis-related respiratory disease - a feasibility study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001361594
Acronym
ACE-CF
Enrollment
17
Registered
2015-12-15
Start date
2016-03-23
Completion date
2017-03-09
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Participants will do four weeks of 'usual' care involving daily breathing exercises (PEP) and walking, running or step ups. After 4 weeks, those who have adhered to these requirements will be randomly allocated to either continue this routine or to stop the PEP and to just continue with the walking, running or step ups for 3 months. Participants will be assessed before and after the four weeks of usual care and at the end of the three month intervention phase.

Interventions

All participants will initially undertake a 4 week wash-in period consisting of the control condition of exercise and positive expiratory pressure therapy (PEP). The exercise consists of walking/running for 30 minutes or step-ups 6 x 5 minutes on a daily basis, with participants able to select which type of exercise they do based on personal preference and external factors (e.g. weather conditions). Intensity for all exercise = 3-5 on the Borg RPE Scale. Participants are encouraged to huff/coug

All participants will initially undertake a 4 week wash-in period consisting of the control condition of exercise and positive expiratory pressure therapy (PEP). The exercise consists of walking/running for 30 minutes or step-ups 6 x 5 minutes on a daily basis, with participants able to select which type of exercise they do based on personal preference and external factors (e.g. weather conditions). Intensity for all exercise = 3-5 on the Borg RPE Scale. Participants are encouraged to huff/cough every 4-5min during walking/running or at the end of the 5min bout of step-ups. Rest time between step-ups is of a duration sufficient to allow performance of these huffs/coughs. These sessions will be done independently at a location (e.g. home, local park) at the choosing of the participants. PEP will consist of 6 cycles of 15 breaths in a seated position through a PariPEP S device. The expiration should be slightly active, achieving a target pressure of 10-20cmH2O. Participants will be encouraged to perform 2-3 huffs, to cough as needed and to then have 1-2min of relaxed breathing between each cycle. PEP will be performed at least once per day. Timing of PEP to exercise will be at the discretion of the participant. Participants reporting adherence with the regimen will then be eligible for randomisation to either the control or intervention groups. The intervention group will cease PEP and only perform the exercise regimen as outlined above. The intervention period runs for 3 months. Adherence will be assessed by participant report at the face-to-face assessments and also by telephone calls from an investigator one and two months into the intervention period. Fitbit Charge HR devices will also be used to assess adherence based on active minutes recorded.

Sponsors

Nathan Ward
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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)

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026