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Trial registered on ANZCTR


Registration number
ACTRN12615001361594
Ethics application status
Approved
Date submitted
7/12/2015
Date registered
15/12/2015
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 288021 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACE-CF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 296895 0
Condition category
Condition code
Human Genetics and Inherited Disorders 297125 297125 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293352 0
Treatment: Other
Comparator / control treatment
After the wash-in period, as outlined in the intervention description, participants randomised to the control group will continue the same regimen used in the wash-in period of exercise and PEP for the 3 month intervention period. 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.
Control group
Active

Outcomes
Primary outcome [1] 296743 0
Feasibility, by the ability to recruit at least 30% of identified eligible patients
Timepoint [1] 296743 0
End of 12 month recruitment period
Primary outcome [2] 296744 0
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
Timepoint [2] 296744 0
End of 4 week wash-in period
Primary outcome [3] 296745 0
Feasibility, by at least 80% of randomised participants completing the intervention phase and follow-up measurements.
Timepoint [3] 296745 0
End of 3 month intervention period
Secondary outcome [1] 319236 0
Cough-related quality of life as assessed by the Leicester Cough Questionnaire
Timepoint [1] 319236 0
end of wash-in and intervention periods
Secondary outcome [2] 319237 0
Respiratory symptom and treatment burden-related quality of life as assessed by the Cystic Fibrosis Questionnaire (Revised)
Timepoint [2] 319237 0
end of wash-in and intervention periods
Secondary outcome [3] 319238 0
Lung function as measured by spirometry (FEV1, FVC, FEF25-75)
Timepoint [3] 319238 0
end of wash-in and intervention periods
Secondary outcome [4] 319239 0
acute respiratory exacerbation rate as measured by additional medications commenced for an increase in respiratory symptoms recorded on a purpose=specific event form
Timepoint [4] 319239 0
end of wash-in and intervention periods
Secondary outcome [5] 319240 0
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).
Timepoint [5] 319240 0
end of wash-in and intervention periods

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
4 week standardised wash-in period to ensure all participants enter the randomised intervention phase from a similar treatment regimen
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility study, no power calculation has been performed. Primary outcomes will be expressed as percentages. Secondary outcomes will be presented as means and standard deviations (or medians and interquartile ranges if not normally distributed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
23/03/2016
Date of last participant enrolment
Anticipated
9/03/2017
Actual
9/03/2017
Date of last data collection
Anticipated
6/07/2017
Actual
7/07/2017
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4782 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 12299 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 292478 0
Hospital
Name [1] 292478 0
Royal Adelaide Hospital
Country [1] 292478 0
Australia
Primary sponsor type
Individual
Name
Nathan Ward
Address
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 291177 0
Individual
Name [1] 291177 0
Kathy Stiller
Address [1] 291177 0
Level 4
Allied Health Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 291177 0
Australia
Secondary sponsor category [2] 291178 0
Individual
Name [2] 291178 0
Hilary Rowe
Address [2] 291178 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [2] 291178 0
Australia
Secondary sponsor category [3] 291179 0
Individual
Name [3] 291179 0
Scott Morrow
Address [3] 291179 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [3] 291179 0
Australia
Secondary sponsor category [4] 291180 0
Individual
Name [4] 291180 0
Judith Morton
Address [4] 291180 0
Chest Clinic
275 North Terrace
Adelaide
SA 5000
Country [4] 291180 0
Australia
Secondary sponsor category [5] 291181 0
Individual
Name [5] 291181 0
Hugh Greville
Address [5] 291181 0
Chest Clinic
275 North Terrace
Adelaide
SA 5000
Country [5] 291181 0
Australia
Secondary sponsor category [6] 291182 0
Individual
Name [6] 291182 0
Anne Holland
Address [6] 291182 0
La Trobe University Clinical School
Alfred Health
Level 4
The Alfred Centre
99 Commercial Rd
Melbourne
Vic 3004
Country [6] 291182 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293942 0
Royal Adelaide Hospital
Ethics committee address [1] 293942 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 293942 0
Australia
Date submitted for ethics approval [1] 293942 0
29/11/2015
Approval date [1] 293942 0
30/12/2015
Ethics approval number [1] 293942 0
HREC/15/RAH/518 (R20151132)
Ethics committee name [2] 293970 0
La Trobe Univsersity Human Ethics Committee
Ethics committee address [2] 293970 0
Ethics and Integrity/Research Office
Plenty Rd & Kingsbury Drive
La Trobe University
Bundoora
Vic 3086
Ethics committee country [2] 293970 0
Australia
Date submitted for ethics approval [2] 293970 0
31/12/2015
Approval date [2] 293970 0
13/01/2016
Ethics approval number [2] 293970 0

Summary
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.
Trial website
Trial related presentations / publications
Thoracic Society of Australia and New Zealand Annual Scientific Meeting presentation (Respirology 2018, 23: Suppl 1: TP066.
Public notes

Contacts
Principal investigator
Name 61858 0
Mr Nathan Ward
Address 61858 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 61858 0
Australia
Phone 61858 0
+61882225574
Fax 61858 0
Email 61858 0
[email protected]
Contact person for public queries
Name 61859 0
Nathan Ward
Address 61859 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 61859 0
Australia
Phone 61859 0
+61882225574
Fax 61859 0
Email 61859 0
[email protected]
Contact person for scientific queries
Name 61860 0
Nathan Ward
Address 61860 0
c/o Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 61860 0
Australia
Phone 61860 0
+61882225574
Fax 61860 0
Email 61860 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAirway clearance by exercising in mild cystic fibrosis (ACE-CF): A feasibility study.2018https://dx.doi.org/10.1016/j.rmed.2018.07.008
N.B. These documents automatically identified may not have been verified by the study sponsor.