Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001285549
Ethics application status
Approved
Date submitted
2/10/2024
Date registered
22/10/2024
Date last updated
22/10/2024
Date data sharing statement initially provided
22/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted treatment for people with dysfunctional breathing and difficult asthma
Scientific title
Feasibility of a targeted multi-dimensional physiotherapy intervention for people with dysfunctional breathing and difficult asthma
Secondary ID [1] 313093 0
Project 478/24
Universal Trial Number (UTN)
U1111-1314-0340
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional breathing 335336 0
Asthma 335337 0
Condition category
Condition code
Respiratory 331925 331925 0 0
Asthma
Respiratory 332033 332033 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 332034 332034 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves participating in a 12 week program (3 weekly sessions, followed by 3 fortnightly sessions) excluding assessments. The assessments will be conducted in-person, and review sessions may be in-person or via telehealth (video or telephone) depending on patient preference. The assessments will take approximately 60mins and the review sessions will take approximately 30 minutes. Patients who choose to undergo review telehealth sessions will require their own device (phone, tablet or computer), and sufficient phone reception or internet. Where physical assessment is required, individuals will be invited to attend in-person. The intervention will be delivered by a physiotherapist and will be individually tailored based on the assessment findings. All participants will undertake breathing re-training and receive education. Breathing re-training may focus on slow breathing +/- controlled breath holds, and exercises to encourage nose and abdominal breathing patterns. Feedback tools may be used such as audio pacing, visual cures or proprioceptive cues. Participants will be provided with exercises to complete at home for approximately 10-20mins daily. All participants will receive education resources from Asthma Australia and Physiotherapy for Breathing Pattern Disorders.
They may also receive exercise therapy, manual therapy (soft tissue massage, joint mobilisations and stretches), relaxation therapy (relaxation exercises and/or referral to mental health services).
Participants who report excessive breathlessness with exercise will be prescribed a home-based exercise program designed to improve their exercise capacity. This will be an endurance based walking program,
All patients will be provided with a home exercise diary to record their home exercises and progress. The diary will also include a checklist of sessions to attend with the physiotherapist.
Intervention code [1] 329650 0
Treatment: Other
Comparator / control treatment
The control group will receive standard medical care. This involves attending their usual medical appointments and continuing their medical management as prescribed by their treating doctor. It may involve being referred to physiotherapy according to medical opinion.
Control group
Active

Outcomes
Primary outcome [1] 339523 0
Feasibility
Timepoint [1] 339523 0
At study completion
Primary outcome [2] 339632 0
Feasibility
Timepoint [2] 339632 0
At study completion
Primary outcome [3] 339633 0
Feasibility
Timepoint [3] 339633 0
At study completion
Secondary outcome [1] 440323 0
Acceptability
Timepoint [1] 440323 0
2 months post completion of the intervention
Secondary outcome [2] 440325 0
Change in hyperventilation symptoms
Timepoint [2] 440325 0
Prior to randomisation; study completion
Secondary outcome [3] 440327 0
Change in breathing pattern
Timepoint [3] 440327 0
Prior to randomisation; study completion
Secondary outcome [4] 440330 0
Change in psychological symptoms
Timepoint [4] 440330 0
Prior to randomisation; study completion
Secondary outcome [5] 440332 0
Change in exercise capacity
Timepoint [5] 440332 0
Prior to randomisation; study completion
Secondary outcome [6] 440681 0
Change in quality of life
Timepoint [6] 440681 0
Prior to randomisation; study completion
Secondary outcome [7] 440682 0
Change in breathlessness
Timepoint [7] 440682 0
Prior to randomisation; study completion
Secondary outcome [8] 440683 0
Change in breathlessness symptoms
Timepoint [8] 440683 0
Prior to randomisation; study completion
Secondary outcome [9] 440684 0
Change in psychological monitoring of breathing symptoms
Timepoint [9] 440684 0
Prior to randomisation; study completion
Secondary outcome [10] 440685 0
Change in respiratory rate
Timepoint [10] 440685 0
Prior to randomisation; study completion
Secondary outcome [11] 440686 0
Change in inspiratory time
Timepoint [11] 440686 0
Prior to randomisation; study completion
Secondary outcome [12] 440687 0
Change in expiratory time
Timepoint [12] 440687 0
Prior to randomisation; study completion
Secondary outcome [13] 440688 0
Change in depth of breathing
Timepoint [13] 440688 0
Prior to randomisation; study completion
Secondary outcome [14] 440689 0
Change in respiratory duty cycle
Timepoint [14] 440689 0
Prior to randomisation; study completion
Secondary outcome [15] 440691 0
Adherence
Timepoint [15] 440691 0
Study completion

Eligibility
Key inclusion criteria
This study will include people aged 18 years and over with difficult asthma and dysfunctional breathing diagnosed by: Nijmegen score greater than or equal to 23 and/or breathing pattern assessment tool score greater than or equal to 4, and able to consent to participate in the study. As the program sessions and educational materials will be delivered in English, participants must be able to read and communicate in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude people who are unable to consent to the study procedures and those that have undergone previous physiotherapy interventions for dysfunctional breathing in the past 12 months.

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)
Allocation will be concealed using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be conducted using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
No power calculation was conducted as this is a pilot feasibility trial designed to test study protocol and determine acceptability. We will aim to randomize 30 participants as this will be sufficient to represent the range of characteristics typical of dysfunctional breathing across the different domains (biochemical, biomechanical, psychophysiological). The trial will not be powered to identify change in the secondary outcomes; however, the outcome effect trial data will inform the sample size calculation for a larger trial.

Feasibility will be reported n (%)

Acceptability:
All de-identified transcripts of the interviews will be analysed by two researchers independently who possess relevant experience in physiotherapy treatment of people with chronic lung disease. Deductive thematic analysis will be used and line-by-line coding will be performed. Descriptive codes will be generated to represent the data. Related codes will be collapsed into defining subthemes. The researchers will then agree on major themes based on theoretical associations between subthemes. Any disagreement will be resolved by discussions. Participants’ verbatim quotes may be extracted from the transcripts to provide supportive data for subthemes.

Adherence:
All home diaries will be reviewed for completion of home practice and reported as n (%) of number of exercises competed that were prescribed.

Effectiveness:
• 2-sided tests will be completed to assess change from baseline to end-intervention for continuous variables (a=0.05). Mean/median will be used depending on distribution.
• n (%) will be reported for dichotomous variables





Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27179 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43262 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317537 0
Hospital
Name [1] 317537 0
In kind support for physiotherapy staff time at Alfred Hospital
Country [1] 317537 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319842 0
Hospital
Name [1] 319842 0
Alfred Hospital
Address [1] 319842 0
Country [1] 319842 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316249 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316249 0
Ethics committee country [1] 316249 0
Australia
Date submitted for ethics approval [1] 316249 0
08/08/2024
Approval date [1] 316249 0
30/08/2024
Ethics approval number [1] 316249 0

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

Contacts
Principal investigator
Name 137282 0
Prof Anne Holland
Address 137282 0
Respiratory Research@ Alfred, 55 Commercial Road, Melbourne, VIC 3004
Country 137282 0
Australia
Phone 137282 0
+61 3 9903 0214
Fax 137282 0
Email 137282 0
[email protected]
Contact person for public queries
Name 137283 0
Janet Bondarenko
Address 137283 0
Physiotherapy Department, Alfred Hospital, 55 Commercial Road, Melbourne, VIC 3004
Country 137283 0
Australia
Phone 137283 0
+61 3 9076 3450
Fax 137283 0
Email 137283 0
[email protected]
Contact person for scientific queries
Name 137284 0
Anne Holland
Address 137284 0
Respiratory Research@Alfred, 55 Commercial Road, Melbourne, VIC 3004
Country 137284 0
Australia
Phone 137284 0
+61 3 9903 0214
Fax 137284 0
Email 137284 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


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
No additional documents have been identified.