Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001237976p
Ethics application status
Submitted, not yet approved
Date submitted
13/08/2020
Date registered
18/11/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
18/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual models for delivery of exercise training in Cystic Fibrosis (CF): an evaluation of patient engagement and feasibility.
Scientific title
Virtual models for delivery of exercise training in CF: an evaluation of patient engagement and feasibility.
Secondary ID [1] 302007 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 318567 0
Condition category
Condition code
Human Genetics and Inherited Disorders 316583 316583 0 0
Cystic fibrosis
Physical Medicine / Rehabilitation 317041 317041 0 0
Physiotherapy
Respiratory 317378 317378 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary rehab is already a well-established treatment modality for patients with chronic respiratory disease. Traditionally, it has been offered in a face-to-face class environment however due to the risk of cross infection, this cannot occur in a CF population. While there is research supporting the benefits of a pulmonary rehabilitation program virtually, this has not been explored with this demographic of patients.

Subsequently, the aim of this study is to evaluate the feasibly and patient engagement with two models of interactive online exercise classes to deliver and promote exercise in adults with Cystic Fibrosis, and patient perceptions of this intervention.

Setup required for the program will require a computer, tablet or mobile device with internet connection. A pilates mat or weights may be required however it will be ensured all participants have access to these prior to commencing the study. The exercise classes in both models will be conducted by the CF physiotherapist. The level of intensity will be monitored by modifed BORG however all patients will be encouraged to self pace during the session based on their own exercise tolerance. The sessions will be 40minutes in length including the warm up and cool down for both exercise models. The duration of the intervention will be 8 weeks with sessions occurring 2x/wkly with a 3rd independent exercise session encouraged. The exercises prescribed to all participants will be standardised however they progressions will be provided for patients for them to choose based on their exercise capacity (eg. sit to stand OR squats OR jump squats). Adherence of the exercise session will be marked on attendance via role call for the traditional model of pulmonary rehab and questionaire for the independent exercise package.

The models of interactive exercise that will be used are a virtual exercise class that occurs in real time with 6 patients and 1 physiotherapist via telehealth. The second model of online exercise class will be an independent package where the patients recruited to this model will be provided with videos for exercise sessions that they will complete independently, un-supervised, in their own time
Intervention code [1] 318292 0
Rehabilitation
Intervention code [2] 318293 0
Treatment: Other
Comparator / control treatment
The control group will complete gold standard pulmonary rehab using a virtual model. This will involve telehealth via the Cisco Jabber platform which will allow patients to interact with the physiotherapist conducting the exercise class. As already outlined, the program will occur 2x/weekly with a 3rd independent exercise session encouraged. Progressions, modifications and feedback on technique will be provided to all participants.
Control group
Active

Outcomes
Primary outcome [1] 324712 0
- Number of exercise sessions completed
Measured by role call of attendance or questionnaire completed by the patient regarding number of sessions they participated in.

The questionnaire has been developed specifically for this study using an online platform from the Metro North Consumer Engagement Platform.
Timepoint [1] 324712 0
Immediately post completion of 8 week program
Primary outcome [2] 325138 0
- Patient satisfaction

Patient satisfaction will be assessed using a Liekert scale on a questionnaire specifically designed for the study, as outlined above. Answers will be de-identfied (they are submitted anonymously) and analysed.
Timepoint [2] 325138 0
Completion of the 8 week program
Primary outcome [3] 325139 0
• Survey developed with local research and Metro North Engage Team.
Focus of feedback will be to assess demand, implementation (study and session completion), practicality (technical issues) and acceptability of training modes and the virtual platform (participant feedback).
• Combination of Likert scales and open-ended questions. Example questions may include: What was your most/least favourite part of the program and why? Would you participate in a similar program again? What type of changes have you seen because of the program, if any? How has the program helped you?
Timepoint [3] 325139 0
Completion of the 8wk program
Secondary outcome [1] 385497 0
Survey.
1. The health outcomes assessed are patient feedback and preference
2. The survey has been designed specifically for use in this study
Timepoint [1] 385497 0
Immediately post 8wk completion of the pulmonary rehab program

Eligibility
Key inclusion criteria
- Patients >18 years of age serviced by the ACFC at The Prince Charles Hospital with a diagnosis of gene confirmed cystic fibrosis.
- RFT’s 30-70% predicted FEV1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe pulmonary disease (RFT’s <30% FEV1)
- Mild pulmonary disease (RFT’s >70% predicted FEV1 )
- Use of domiciliary oxygen therapy
- Unable to perform exercise as determined by the medical and/or physiotherapy team
- Death is deemed imminent or the patient is actively being palliated
- Patients/NOK on patients behalf do not consent to participate

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The key statistics are differences in patient engagement correlated with the model of virtual pulmonary rehab in which they are allocated. Data will undergo analysis and interpretation by the principal investigators and statistician using parametric/non-parametric statistics as appropriate. Between-group comparison of categorical data will be performed using Chi square or logistical regression and comparisons of the data will be made. Descriptive statistics will quantify all outcomes pre and post the exercise intervention. Pairwise comparisons will be made for all measures pre and post the exercise intervention. Results will be accepted as statistically significant at p< 0.05.

Descriptive analysis of the post quantitative questions will be performed. Responses to open ended questions will be coded and organised, and a thematic analysis will be conducted to identify themes about the feasibility and acceptability of the programs to the participants.

As this is a pilot, feasibility study, it is difficult to calculate an appropriate sample side required to effectively power it. Therefore, this proposal is using a convenience sample of 12 patients assigned to each virtual mode that are likely to be recruited during the study period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/12/2020
Actual
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17242 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 30951 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 306428 0
Hospital
Name [1] 306428 0
The Physiotherapy Department The Prince Charles Hospital
Country [1] 306428 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital
627 Rode Road
Chermside, 4032
QLD
Country
Australia
Secondary sponsor category [1] 306943 0
None
Name [1] 306943 0
Address [1] 306943 0
Country [1] 306943 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306637 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 306637 0
Ethics committee country [1] 306637 0
Australia
Date submitted for ethics approval [1] 306637 0
13/08/2020
Approval date [1] 306637 0
Ethics approval number [1] 306637 0

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

Contacts
Principal investigator
Name 104510 0
Miss Kelly Burgess
Address 104510 0
The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032
Country 104510 0
Australia
Phone 104510 0
+61 7 3139 6272
Fax 104510 0
Email 104510 0
[email protected]
Contact person for public queries
Name 104511 0
Kelly Burgess
Address 104511 0
The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032
Country 104511 0
Australia
Phone 104511 0
+61 7 3139 6272
Fax 104511 0
Email 104511 0
[email protected]
Contact person for scientific queries
Name 104512 0
Kelly Burgess
Address 104512 0
The Prince Charles Hospital
627 Rode Road
Chermside, QLD 4032
Country 104512 0
Australia
Phone 104512 0
+61 7 31396272
Fax 104512 0
Email 104512 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8760Study protocol    380363-(Uploaded-13-08-2020-02-17-15)-Study-related document.docx
8762Informed consent form    380363-(Uploaded-13-08-2020-03-09-38)-Study-related document.docx



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.