Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000571471
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a brief behavioural intervention on physical activity in people with pulmonary fibrosis
Scientific title
Effect of a brief behavioural intervention on physical activity in people with pulmonary fibrosis
Secondary ID [1] 314444 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung Disease 337478 0
Pulmonary Fibrosis 337634 0
Condition category
Condition code
Respiratory 333847 333847 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive one counselling session, in-person or remotely, conducted by a trained researcher (approximately one-hour). The counselling will follow the behaviour change principles of capability, opportunity and motivation model including education about the importance of being physically active, how to improve physical activity (PA) and keep motivated. A Fitbit, an 8-week individualized step goal based on the 6MWT and an information leaflet on the benefits of PA according to Australian Department of Health will be given following the session. It is expected that follow-up calls will take approximately 30-minutes. Participants will receive follow-up phone calls at 4 and 8 weeks for PA behavioural reinforcement. After 8-weeks, participants will be allowed to keep the Fitbit, however no further individual goal setting will occur.
Intervention code [1] 331067 0
Behaviour
Comparator / control treatment
Participants will receive the physical activity information leaflet only.
Control group
Active

Outcomes
Primary outcome [1] 341464 0
Change in physical activity
Assessment method [1] 341464 0
International Physical Activity Questionnaire Long Form (IPAQ-LF);
Timepoint [1] 341464 0
Baseline, weeks 8 (primary endpoint) and 4 months post-counselling session
Secondary outcome [1] 447590 0
Change in symptom.
Assessment method [1] 447590 0
Change in symptoms will be assessed by the living with PF questionnaire (L-PF). A fibrotic PF specific quality of life questionnaire which has shown to be responsiveness to changes in patients’ perceptions of their quality of life.
Timepoint [1] 447590 0
Baseline, weeks 8 and 4 months post-counselling session
Secondary outcome [2] 448070 0
Change in fatigue
Assessment method [2] 448070 0
Change in fatigue will be measured using the Fatigue Severity Scale (FSS), a valid, sensitive measure in PF with responsiveness to change
Timepoint [2] 448070 0
Baseline, weeks 8 and 4 months post-counselling session
Secondary outcome [3] 448071 0
Feasibility
Assessment method [3] 448071 0
Feasibility will be assessed by recording the number of participants with interstitial lung disease referred to pulmonary rehabilitation that meet the inclusion criteria the number of participants approached, the number who consented and number and reasons of participants withdrawn. This data will be collected from the pulmonary rehabilitation referrals, medical records and will be recorded in the study database.
Timepoint [3] 448071 0
4 months post-counselling session
Secondary outcome [4] 448072 0
Change in physical activity
Assessment method [4] 448072 0
Change in physical activity will also be assessed by the 7-day PA recall. The 7-day recall is a valid and reliable questionnaire in elderly and sedentary population.
Timepoint [4] 448072 0
Baseline, weeks 8 and 4 months post-counselling session
Secondary outcome [5] 448073 0
Adherence
Assessment method [5] 448073 0
Adherence will be assessed by recording the proportion of participants who adhered to the planned step goals and protocol by data downloaded from the Fitbit app and recorded in the study database. Participants will also receive a phone call after 8 weeks and participate in an interview after the intervention period to confirm adherence to the step goal.
Timepoint [5] 448073 0
4 months post-counselling session
Secondary outcome [6] 448074 0
Change in 6 minute walking distance
Assessment method [6] 448074 0
Change in 6 minute walk distance, obtained from 6MWT, will be used to evaluate weather functional capacity benefits are sustained over time.
Timepoint [6] 448074 0
Baseline and 4 months post-counselling session

Eligibility
Key inclusion criteria
Participants aged 18 years and over with a confirmed diagnosis of PF, able to read and speak English and provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be if they have a significant cognitive impairment, are unable to use the physical activity tracker or accompanying app or if there is an anticipated transplant or death within the duration of the study period

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2025
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
40
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318981 0
Other Collaborative groups
Name [1] 318981 0
Centre of Research Excellence in Pulmonary Fibrosis
Country [1] 318981 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre of Research Excellence in Pulmonary Fibrosis
Country
Australia
Secondary sponsor category [1] 321546 0
None
Name [1] 321546 0
None
Country [1] 321546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317585 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317585 0
Ethics committee country [1] 317585 0
Australia
Date submitted for ethics approval [1] 317585 0
13/11/2024
Approval date [1] 317585 0
20/11/2024
Ethics approval number [1] 317585 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 141498 0
Dr Dr Mariana Hoffman
Address 141498 0
Monash University, School of Translational Medicine - L6 99 Commercial Road Melbourne VIC 3004
Country 141498 0
Australia
Phone 141498 0
+61 0399030568
Email 141498 0
mariana.hoffman1@monash.edu
Contact person for public queries
Name 141499 0
Dr Mariana Hoffman
Address 141499 0
Monash University, School of Translational Medicine - L6 99 Commercial Road Melbourne VIC 3004
Country 141499 0
Australia
Phone 141499 0
+61 0399030568
Email 141499 0
mariana.hoffman1@monash.edu
Contact person for scientific queries
Name 141500 0
Dr Mariana Hoffman
Address 141500 0
Monash University, School of Translational Medicine - L6 99 Commercial Road Melbourne VIC 3004
Country 141500 0
Australia
Phone 141500 0
+61 406 040 082
Email 141500 0
mariana.hoffman1@monash.edu

Data sharing statement
Will the study consider sharing individual participant data?
No


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.