Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000428864
Ethics application status
Approved
Date submitted
7/03/2021
Date registered
16/04/2021
Date last updated
23/02/2024
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Airway clearance techniques for individuals with an acute exacerbation of bronchiectasis: a randomised controlled trial
Scientific title
Active cycle of breathing technique versus oscillating PEP therapy versus exercise with huffing during an acute exacerbation of bronchiectasis: a randomised controlled trial
Secondary ID [1] 303609 0
Wesley Medical Research: project reference number 2020-16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 320980 0
Condition category
Condition code
Respiratory 318788 318788 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 319224 319224 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will continue to receive usual care including medical therapy (including but not limited to antibiotics, corticosteroids, supplemental oxygen), nursing care, a walking program with the goal to return to previous level of function, and other allied health interventions as required.
Participants will be randomly allocated by the chief investigator to one of three arms:
Arm 1. Exercise with huffing and usual care
Arm 2. The Active Cycle of Breathing Technique (ACBT), and usual care
Arm 3. Oscillating-PEP therapy, and usual care
All interventions will be supervised once daily by a physiotherapist whilst the participant is an inpatient, and participants requested to complete the intervention twice daily unsupervised whilst an inpatient, and unsupervised on discharge from hospital.

Arm 1: Exercise with huffing
Participants randomly assigned to arm 1 will complete a standardised exercise program based on over-ground walking in combination with directed huffing, with the goal of airway clearance. Participants will self-select their walking speed to a modified Borg scale level of 3-5 whilst maintaining acceptable blood oxygen saturation levels and heart rate range as determined by usual values or acceptable altered parameters prescribed by the participant’s treating respiratory physician. The goal will be to complete a total of 30 minutes/day, so whilst inpatients participants will be instructed to walk for 10 minutes, 3 times per day combined with a series of huffs at the end of the session. As outpatients, participants will maintain the goal of 30 minutes/day in combination with huffing. A huff involves breathing out with mild-moderate force to aid clearance of sputum from the lungs.

Arm 2: Active cycle of breathing technique (ACBT)
Participants will be positioned upright in a chair or sitting up in bed if unable to sit in a chair. The ACBT consists of three components which will be implemented: breathing control, thoracic expansion exercises and a huff. The cycle will involve:
1. Breathing control – participant to breathe at their usual rate and depth
2. Thoracic expansion – participant to breathe in slowly and deeply, pause for 1-2 seconds, breathe out fully but not forcefully. Repeated 2 to 3 times.
3. Return to breathing control as above
4. Thoracic expansion exercises as above repeated 2 – 3 times.
5. Return to breathing control as above
6. Huff – participant to take a slightly deeper breath than normal in, open mouth and keep it ‘O’ shaped, then breathe out more forcefully using abdominal muscles to assist. It should sound like a forced sigh. Participants to repeat 2 to 3 times with breathing control in between as needed.
7. Return to breathing control until ready to begin another cycle.
The participant may cough if needed throughout the cycle. The participants will be instructed to complete a minimum of three cycles each session, or until the end points listed below.

Arm 3: Oscillating PEP therapy
The Oscillating -PEP therapy will use an Aerobika device. Participants will be positioned in forward lean sitting in a chair or sitting up in bed if unable to sit in a chair. The participant will complete 10 breaths, followed by a huff, and then a cough only if needed. This cycle will then be completed a minimum of three times or until the end points listed below.

End Points
The end points for all three arms will be:
1. Two non-productive cycles plus clear huff
2. Terminated by participant or physiotherapist for other reasons (such as participant fatigue, or the participant reporting subjectively feeling clear).
3. Productive cough remaining, or huff not clear, but session reached maximum time of 30 minutes.

Participants will be recruited on admission to hospital and followed up for six months post discharge. Whilst they are inpatients, participants will be instructed by the ward physiotherapist to complete their allocated intervention three times daily, once supervised and twice independently. On discharge, participants will be instructed to continue their allocated technique twice daily.

Compliance will be monitored through daily interviews (inpatient stay) and a weekly diary and monthly phone calls/email contact (upon discharge). The phone calls will collect information regarding adherence to ACT and clinical status in the previous month, including a change in cough/sputum, any hospital admissions or use of antibiotics. If participants are unable to be contacted via phone, they will also be contacted via email to minimise gaps in data.
Intervention code [1] 319893 0
Treatment: Other
Comparator / control treatment
Arm 1: Exercise with huffing will act at the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 326731 0
The primary outcome will be total sputum volume, measured by the wet weight of sputum collected in a 24 hour period
Timepoint [1] 326731 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
Secondary outcome [1] 392500 0
Sputum volume (wet weight) during airway clearance session (from commencement of airway clearance session to completion of airway clearance session, or a maximum of 30 minutes as per the end points listed above).
Timepoint [1] 392500 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
Secondary outcome [2] 392501 0
Sputum volume (wet weight) in the hour following airway clearance session
Timepoint [2] 392501 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
Secondary outcome [3] 392502 0
Health status assessed using Bronchiectasis Health Questionnaire
Timepoint [3] 392502 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
8 weeks post discharge from hospital
6 months post discharge from hospital
Secondary outcome [4] 392503 0
Disease specific quality of life assessed using the Quality of Life – bronchiectasis questionnaire
Timepoint [4] 392503 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
8 weeks post discharge from hospital
6 months post discharge from hospital
Secondary outcome [5] 392504 0
Disease specific quality of life assessed using the Leicester Cough Questionnaire
Timepoint [5] 392504 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
8 weeks post discharge from hospital
6 months post discharge from hospital
Secondary outcome [6] 392505 0
Exercise capacity assessed using the 6 minute walk test
Timepoint [6] 392505 0
Day 2 of hospital admission
Day 6 of hospital admission
Day of discharge from hospital
6 months post discharge from hospital
Secondary outcome [7] 392506 0
Exacerbation symptoms assessed using the Bronchiectasis Exacerbation Symptom Tool Questionnaire
Timepoint [7] 392506 0
Daily from hospital discharge to 6 months post discharge from hospital
Secondary outcome [8] 392507 0
Exacerbations assessed via participant self report use of antibiotics or change of treatment
Timepoint [8] 392507 0
Recorded number/month for 6 months post discharge from hospital
Secondary outcome [9] 392508 0
Hospital admissions (participant reported)
Timepoint [9] 392508 0
Recorded for 6 months post discharge from hospital

Eligibility
Key inclusion criteria
Adults admitted to Hospital with an acute exacerbation of bronchiectasis, will participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Primary diagnosis of a respiratory condition other than bronchiectasis (as defined by respiratory physician)
• Breathing through an artificial airway
• Undrained or drained pneumothorax within the last 6 months
• Post lung lobectomy or lung transplant
• Haemodynamic instability or severe cardiovascular disease
• Undrained empyema or lung abscess
• Active severe haemoptysis
• Middle ear infection
• Hyper-reactive airways as diagnosed by a respiratory physician
• Patients who are too unwell to understand the study or provide consent

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2021
Actual
11/05/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
9/08/2023
Date of last data collection
Anticipated
12/02/2024
Actual
9/02/2024
Sample size
Target
90
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308029 0
University
Name [1] 308029 0
Bond University
Country [1] 308029 0
Australia
Funding source category [2] 308030 0
Charities/Societies/Foundations
Name [2] 308030 0
Wesley Medical Research
Country [2] 308030 0
Australia
Primary sponsor type
University
Name
Bond University
Address
2 Promethean Way, Robina, QLD, 4226
Country
Australia
Secondary sponsor category [1] 308753 0
Hospital
Name [1] 308753 0
The Wesley Hospital
Address [1] 308753 0
451 Coronation drive, Auchenflower, QLD 4066
Country [1] 308753 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308020 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [1] 308020 0
Ethics committee country [1] 308020 0
Australia
Date submitted for ethics approval [1] 308020 0
Approval date [1] 308020 0
09/02/2021
Ethics approval number [1] 308020 0
Ethics committee name [2] 308021 0
Bond University Human Research Ethics Committee
Ethics committee address [2] 308021 0
Ethics committee country [2] 308021 0
Australia
Date submitted for ethics approval [2] 308021 0
Approval date [2] 308021 0
22/02/2021
Ethics approval number [2] 308021 0
Ethics committee name [3] 308022 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [3] 308022 0
Ethics committee country [3] 308022 0
Australia
Date submitted for ethics approval [3] 308022 0
Approval date [3] 308022 0
15/02/2021
Ethics approval number [3] 308022 0
Ethics committee name [4] 308023 0
Monash University Human Research Ethics Committee
Ethics committee address [4] 308023 0
Ethics committee country [4] 308023 0
Australia
Date submitted for ethics approval [4] 308023 0
Approval date [4] 308023 0
25/02/2021
Ethics approval number [4] 308023 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109254 0
Ms Jennifer Phillips
Address 109254 0
Bond University, 2 Promethean Way Robina, QLD, 4226
Country 109254 0
Australia
Phone 109254 0
+61 7 5595 1143
Fax 109254 0
Email 109254 0
[email protected]
Contact person for public queries
Name 109255 0
Jennifer Phillips
Address 109255 0
Bond University, 2 Promethean Way Robina, QLD, 4226
Country 109255 0
Australia
Phone 109255 0
+61 7 5595 1143
Fax 109255 0
Email 109255 0
[email protected]
Contact person for scientific queries
Name 109256 0
Jennifer Phillips
Address 109256 0
Bond university 2 Promethean Way Robina, QLD, 4226
Country 109256 0
Australia
Phone 109256 0
+61 7 5595 1143
Fax 109256 0
Email 109256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared due to the sensitivity of personal health information and to comply with hospital and HREC policies.


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
EmbaseActive cycle of breathing technique versus oscillating PEP therapy versus walking with huffing during an acute exacerbation of bronchiectasis: a randomised, controlled trial protocol.2023https://dx.doi.org/10.1186/s12890-023-02324-8
N.B. These documents automatically identified may not have been verified by the study sponsor.