Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000725864
Ethics application status
Approved
Date submitted
6/10/2020
Date registered
9/06/2021
Date last updated
8/06/2022
Date data sharing statement initially provided
9/06/2021
Date results provided
8/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Beam Feel Good Website for individuals with Cystic Fibrosis (CF)
Scientific title
Pilot study to evaluate the use and impact of Beam Feel Good: a website designed specifically for individuals with Cystic Fibrosis to promote movement and physical activity.
Secondary ID [1] 302476 0
Nil Known
Universal Trial Number (UTN)
U1111-1259-2756
Trial acronym
BFGIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 319308 0
Condition category
Condition code
Respiratory 317277 317277 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 319532 319532 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual group sessions will be scheduled 2-3 times a week; participants will be able to login to the group through the Beam site and these sessions will be facilitated by the treating physiotherapist.
Virtual group sessions will include education and completing one or more of the on-demand exercise routines that are available on the Beam Feel Good website, these classes will have up to 10 participants attending, including one physiotherapist.
The education sessions included in these virtual classes will be led by the physiotherapist and will include focus on techniques and education already provided in routine clinical care, to enhance the session for the participants, this will include methods of combining airway clearance techniques with exercise, and education around self-care and injury prevention/management.
Participants will have access to the website 24/7 and able to explore the resources available to them over the 10 week intervention period.
Safety protocols will be in place if exercise is being undertaken by participants. All participants will have knowledge of the BORG and RPE (rate of perceived exertion scales) and they will be asked to enter these in the chat facility at the beginning and end of each session, they also have personal SpO2 monitors and heart rate and oxygen levels will also be monitored during the exercise sessions. Buddy systems will be set up to ensure the physiotherapist has knowledge of contact details of someone other than the participant and knowledge of the geographical location of the participant (physical address) should there be an unexpected emergency during the session.
Participants will login using their own login details which they will have completed through the Beam onboarding process.
Participants will have full control over their level of involvement and identification, video on or off; and alias option for their username (the alias will be disclosed to the treating physiotherapist for safety purposes).
There is no expectation of usage of the site, as this is a pilot trial we are wanting to explore the usage and then barriers and enablers.
The exercise sessions will be guided by the group and individuals will be supported by the treating physiotherapist to ensure they are safe and suitable intensity for their health status.
The exercise types will range from high intensity interval training, to yoga, to stretches; these will range in time from 25 minutes to 40 minutes and the types of activity will be determined by the exercise video resources already available on the website platform.
Target intensity for training will be discussed with each participant based on BORG (aiming for 6/10) and heart rate.
Web-portal analytics will be evaluated to review usage and adherence with exercise sessions.
Intervention code [1] 318770 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325335 0
Use of website - this will be assessed by web-portal analytics, through the clinical portal and also through the individual sign in usage rate
Timepoint [1] 325335 0
3 months post enrolment
Primary outcome [2] 325336 0
Self reported physical activity participation; this will be evaluated through the physical habitual activity survey and also in the phone interview on completion of the study
Timepoint [2] 325336 0
baseline and three months post-enrolment
Secondary outcome [1] 387571 0
Exercise capacity using the one minute sit to stand test
Timepoint [1] 387571 0
baseline and three months post-enrolment
Secondary outcome [2] 387573 0
Spirometry - FEV1, FVC
Timepoint [2] 387573 0
Baseline and three months post enrolment - this measure will not be collected in post transplant participants
Secondary outcome [3] 394954 0
semi-structured qualitative interview to evaluate barriers and enablers to using the website; and determine any carry over of changes in exercise behaviour during the trial
Timepoint [3] 394954 0
3 months post-enrolment

Eligibility
Key inclusion criteria
Confirmed diagnosis of Cystic Fibrosis
Receiving care from the Tasmanian Adult Cystic Fibrosis Unit
A current financial member of Cystic Fibrosis Tasmania
Able to provide informed consent
Able to access the internet via a computer
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a severe comorbidity limiting mobilisation or physical activity.
Previous lung transplantation, pregnancy and other complications of CF that may be considered a precaution - will need individual consultation with treating team to be safely included.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a pilot trial and the investigator is aware the participant numbers will not be of adequate statistical significance for any power calculations. Therefore the data will be presented as such and if no adverse outcomes, and the participants engaged in the intervention conclusions will be determined for a larger clinical trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/05/2021
Date of last participant enrolment
Anticipated
18/06/2021
Actual
29/06/2021
Date of last data collection
Anticipated
30/09/2021
Actual
28/09/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 17748 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 17749 0
Launceston General Hospital - Launceston
Recruitment hospital [3] 17750 0
North West Regional Hospital - Burnie
Recruitment postcode(s) [1] 31611 0
7000 - Hobart
Recruitment postcode(s) [2] 31612 0
7250 - Launceston
Recruitment postcode(s) [3] 31613 0
7320 - Burnie

Funding & Sponsors
Funding source category [1] 306900 0
Hospital
Name [1] 306900 0
Royal Hobart Hospital
Country [1] 306900 0
Australia
Primary sponsor type
Hospital
Name
Royal Hobart Hospital
Address
GPO Box 1061
Hobart Tasmania 7001
Country
Australia
Secondary sponsor category [1] 307460 0
None
Name [1] 307460 0
Address [1] 307460 0
Country [1] 307460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307054 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 307054 0
Ethics committee country [1] 307054 0
Australia
Date submitted for ethics approval [1] 307054 0
01/05/2020
Approval date [1] 307054 0
18/09/2020
Ethics approval number [1] 307054 0
20237

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

Contacts
Principal investigator
Name 105866 0
Mrs Jenny Hauser
Address 105866 0
Royal Hobart Hospital
Tasmanian Adult Cystic Fibrosis Unit
70 Collin Street
Hobart TAS 7000
Country 105866 0
Australia
Phone 105866 0
+61 3 6166 7556
Fax 105866 0
Email 105866 0
[email protected]
Contact person for public queries
Name 105867 0
Jenny Hauser
Address 105867 0
Royal Hobart Hospital
Tasmanian Adult Cystic Fibrosis Unit
70 Collin Street
Hobart TAS 7000
Country 105867 0
Australia
Phone 105867 0
+61 3 6166 7556
Fax 105867 0
Email 105867 0
[email protected]
Contact person for scientific queries
Name 105868 0
Jenny Hauser
Address 105868 0
Royal Hobart Hospital
Tasmanian Adult Cystic Fibrosis Unit
70 Collin Street
Hobart TAS 7000
Country 105868 0
Australia
Phone 105868 0
+61 3 6166 7556
Fax 105868 0
Email 105868 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.