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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001361594
• Date of registration: 15/12/2015
• Prospective Registration: Yes
• Primary sponsor: Nathan Ward
• Public title: Airway Clearance by Exercising in mild Cystic Fibrosis (ACE-CF): a feasibility study.
• Scientific title: 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.
• Date of first enrolment: 23/03/2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001361594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Nathan Ward

• Name: Mr Nathan Ward

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Human Genetics and Inherited Disorders - Cystic fibrosis

Cystic Fibrosis;
Cystic Fibrosis

Intervention(s)

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.

Primary Outcome(s)

Feasibility, by at least 80% of randomised participants completing the intervention phase and follow-up measurements.[End of 3 month intervention period]

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]

Secondary Outcome(s)

Lung function as measured by spirometry (FEV1, FVC, FEF25-75)[end of wash-in and intervention periods]

acute respiratory exacerbation rate as measured by additional medications commenced for an increase in respiratory symptoms recorded on a purpose=specific event form[end of wash-in and intervention periods]

Cough-related quality of life as assessed by the Leicester Cough Questionnaire[end of wash-in and intervention periods]

adverse events including but not limited to: haemoptysis, pneumothorax, new colonisation of Pseudomonas aeruginosa/Burkholderia cepacia/Non-tuberculosis Mycobacteria, Distal Intestinal Obstruction Syndrome, new or significantly increased chest pain, new or significantly increased musculoskeletal pain, other. These will all be assessed by participant self-reporting to the investigators and casenote review (e.g. for sputum results).[end of wash-in and intervention periods]

Respiratory symptom and treatment burden-related quality of life as assessed by the Cystic Fibrosis Questionnaire (Revised)[end of wash-in and intervention periods]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Royal Adelaide Hospital

Secondary Sponsor(s)

Scott Morrow

Hilary Rowe

Judith Morton

Kathy Stiller

Anne Holland

Hugh Greville

Ethics review

Status: Approved
Approval date:
Contact:

La Trobe Univsersity Human Ethics Committee

Status: Approved
Approval date:
Contact:

Royal Adelaide Hospital