Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000116426
Ethics application status
Approved
Date submitted
15/01/2025
Date registered
3/02/2025
Date last updated
20/04/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a telehealth exercise model of care for adults with Cystic Fibrosis: A feasibility randomised controlled trial
Scientific title
Evaluating a telehealth exercise model of care for adults with Cystic Fibrosis: A feasibility randomised controlled trial
Secondary ID [1] 313677 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 336249 0
Condition category
Condition code
Human Genetics and Inherited Disorders 332790 332790 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will be allocated to the new telehealth model of care. In this model of care, participants will be given a choice of participating in either an independent exercise program with weekly check in sessions from a physiotherapist (Option A) or a live supervised group exercise program (Option B). The duration of both intervention groups will be 12 weeks. Participants in both intervention groups will be provided with an exercise diary and asked to record their exercise participation throughout the program. Participants will also have access to a peer support messaging group for the duration of the 12-week program.

Option A: Independent Exercise program with weekly check in sessions
- Participants will attend an Initial telehealth video session (at baseline, week 0) with a physiotherapist who will discuss the participant's exercise preferences and set initial goals. The physiotherapist will provide the participant with an individually tailored exercise program based on their exercise preferences and goals during this initial session. -The individually tailored exercise program will include a combination of cardiovascular exercise (eg. walking, jogging, or cycling) and strength or flexibility training exercises. The exercise training intensity for each participant will be individualised to each participant based on the current CF exercise guidelines which recommend that people with CF should exercise to approximately 75% of their maximum heart rate. The maximum heart rate recorded during the participant's exercise test completed during initial participant assessment (at baseline, week 0) will be used to calculate 75% of the participant's maximum heart rate. The participant's will be educated on how to manually take their own heart rate during exercise (via peripheral pulse rate) or they may choose to use a wearable exercise tracker device if they already own one.
- The telehealth video sessions will be conducted via the Alfred Hospital Health Direct platform which participants may have some experience using for their usual Cystic Fibrosis (CF) outpatient care. The participant will be sent a link to access this platform via text message or email.
- Weekly check in sessions will be provided to the participant by a CF Physiotherapist via telephone call, text messaging, or email based on the participant’s preference. The purpose of these check ins will be to review the participant’s progress with their exercise program and adjust exercise prescription if required on an individual basis.
- Participants can also request an individual telehealth video review with the physiotherapist at any time during the program to review their exercise program.

Option B: Live supervised telehealth group exercise program
- Participants will attend a live supervised telehealth group exercise program via Zoom two times per week run by a CF Physiotherapist.
- The Alfred Hospital Zoom account will be used for this group.
- Each participant will complete their own individual, tailored exercise program during the telehealth sessions after a shared group warm up. The exercise program will be tailored to the individual participant based on their exercise preferences and goals which will be discussed with the participant at their baseline assessment (week 0) in person.
- Each session will be sixty minutes in duration, with participants completing approximately 50 minutes of exercise training including warm up (10 minutes), individual strength training program (30 minutes) and stretching exercises (10 minutes), and 10 minutes of optional peer support at the end of the session.
- Participants will be able to choose the timing of the exercise session that best suits their schedule and lifestyle from a selection of options. There will be options for day time and evening sessions.
- During the session the physiotherapist will record the participant’s exercise program in an exercise recording sheet and monitor them using modified BORG shortness of breath (SOB) and rate of perceived exertion (RPE) scales.
- Additional information such as heart rate and Spo2 may be collected if participants have access to this information such as their own wearable fitness tracker device or portable oximeter.
- The exercise recording sheet will be recorded in the patient’s electronic medical record.

Exercise Diary:
All participants in the intervention group will be asked to complete an exercise diary for the duration of the 12-week telehealth exercise intervention. Participants will be given an exercise diary based on the exercise intervention that they select. Participants will be asked to record their exercise participation in symptoms including any adverse events related to exercise participation. The exercise diary will be personalised to the individual participant based on the participant's preferences identified in the initial assessment and individual exercise prescription. All participants will be asked to record the amount of cardiovascular exercise completed each day, and completions of other exercises (eg. individual strength or flexibility training exercises). They will also be asked to record their shortness of breath using a modified BORG scale and their rate of perceived exertion using RPE scales. Additional information such as heart rate and Spo2 may be collected if participants have access to this information such as their own wearable fitness tracker or portable oximeter.

Peer Support Group:
- Participants in the intervention group will be given the option to sign up for an online peer support messaging group. This is a key component of the telehealth model of care that was requested by participants during the previous focus group study.
- This group will be a private group in Microsoft Teams and will be moderated by the student investigator.
- A private channel will be created by the student investigator using an Alfred Health log in on Microsoft Teams.
- Participants will only be able to join this team through individual email invitations from the student investigator.
- The privacy settings will be set up in Microsoft teams to ensure that participants are unable to invite other people to join the peer support group.
- Participants will be able to create “posts” and reply to each other within the Microsoft Teams group.
- Participants will be able to delete their own posts, but will not be able to delete posts from other participants. The student investigator will moderate the peer support group and have the ability to delete all participant posts if required.
Intervention code [1] 330270 0
Treatment: Other
Comparator / control treatment
Participants in the control group will continue with their usual CF care and be instructed to continue their usual exercise routine. Routine care may include the participant being seen by a physiotherapist as part of a Cystic Fibrosis outpatient clinic appointment, during an inpatient admission or outside of this time by referral or patient request.
Control group
Active

Outcomes
Primary outcome [1] 340318 0
Program Completion: The number of participants who complete their chosen telehealth exercise intervention over 12 weeks. Completion will be defined based on international standards in chronic respiratory disease as completing 70% of scheduled sessions.
Timepoint [1] 340318 0
12 weeks (post intervention period)
Secondary outcome [1] 443691 0
Safety: Number of adverse events that occur in participants related to participation in the telehealth exercise program.
Timepoint [1] 443691 0
Adverse events will be recorded throughout the study period (0-12 weeks) and assessed at the end of week 12 (post intervention period).
Secondary outcome [2] 443692 0
Recruitment: Number of eligible participants who consent to take part in the study
Timepoint [2] 443692 0
This data will be collected throughout the study recruitment period and assessed at the end of the study recruitment period.
Secondary outcome [3] 443693 0
Completion of follow up: Number of participants who attend two face-to-face assessments
Timepoint [3] 443693 0
12 weeks (post intervention)
Secondary outcome [4] 443694 0
Intervention preference: Number of participants who choose each intervention option in the telehealth exercise intervention model of care (Option A or Option B)
Timepoint [4] 443694 0
Baseline
Secondary outcome [5] 443695 0
Assessment preference: Number of participants who complete the Alfred Step Test Protocol (A-STEP), Modified shuttle 25-level test (MST-25) and/or 6-minute walk test (6MWT) exercise assessments.
Timepoint [5] 443695 0
Baseline and end intervention assessment time point.
Secondary outcome [6] 443696 0
Patient satisfaction: of completing check in sessions via telehealth (Option A) and the telehealth exercise program via Zoom (Option B) measured by the Telehealth Satisfaction Scale (TeSS).
Timepoint [6] 443696 0
End of intervention assessment (12 weeks)
Secondary outcome [7] 443698 0
Usability: Usability of the peer support group measured by the System Usability Scale (SUS).
Timepoint [7] 443698 0
End of intervention assessment time point (12 weeks)
Secondary outcome [8] 443699 0
Clinical change: Change in MST-25 distance at baseline and after program completion.
Timepoint [8] 443699 0
Baseline and 12 weeks (post intervention).
Secondary outcome [9] 443872 0
Clinical change: Change in A-STEP level at baseline and after program completion
Timepoint [9] 443872 0
Baseline and 12 weeks (post intervention)
Secondary outcome [10] 443873 0
Clinical change: Change in AWESCORE at baseline and after program completion.
Timepoint [10] 443873 0
Baseline and 12 weeks (post intervention)

Eligibility
Key inclusion criteria
• Adults (18 years of age or older)
• Confirmed diagnosis of CF by either a positive sweat test (chloride >60 mmol/L) or presence of two CF-causing genetic mutations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals who have previously indicated that they do not wish to be involved in studies or clinical trials
• History of lung transplantation
• Comorbidities that preclude exercise testing or training
• Pregnancy
• Pneumothorax within the last 6 months
• Haemoptysis >20mls in the 30 days prior to baseline assessment


Delayed study entry:
• Patients currently experiencing a period of clinical instability (i.e acute chest exacerbation, hospital admission or change to usual CF therapy for the previous 30 day period1) may be recruited to the study however they will be unable to commence the study including completion of baseline assessment measures until they are deemed to be clinically stable.

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)
The randomisation sequence will be generated using an online website. Randomisation will occur after the participant has completed their initial assessment. The randomisation sequence will be concealed using sealed opaque envelopes. The randomisation sequence will be prepared by investigators not involved in participant recruitment, assessment or intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using an online website (randomisation.com). Randomisation will occur in a two to one ratio, with twice as many participants being randomised to the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
10/04/2025
Date of last participant enrolment
Anticipated
22/09/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318140 0
Hospital
Name [1] 318140 0
Alfred Hospital Physiotherapy Department Senior Physiotherapist Research Fellowship
Country [1] 318140 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320523 0
None
Name [1] 320523 0
Address [1] 320523 0
Country [1] 320523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316785 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316785 0
Ethics committee country [1] 316785 0
Australia
Date submitted for ethics approval [1] 316785 0
24/10/2024
Approval date [1] 316785 0
15/11/2024
Ethics approval number [1] 316785 0
Project Number: 110261 (Local Reference: Project 630/24)

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

Contacts
Principal investigator
Name 139006 0
Prof Anne Holland
Address 139006 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 139006 0
Australia
Phone 139006 0
+61 0419379821
Fax 139006 0
Email 139006 0
[email protected]
Contact person for public queries
Name 139007 0
Meg Poulsen
Address 139007 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 139007 0
Australia
Phone 139007 0
+61 418549111
Fax 139007 0
Email 139007 0
[email protected]
Contact person for scientific queries
Name 139008 0
Anne Holland
Address 139008 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 139008 0
Australia
Phone 139008 0
+61 0419379821
Fax 139008 0
Email 139008 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Participant data will be shared at the discretion of the investigators upon reasonable request and with the oversight of the appropriate HREC.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?
• Data will be available only to achieve the aims in the approved proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available following publication with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access to data will be subject to approvals by Principal Investigator Prof Anne Holland via email [email protected].

Are there extra considerations when requesting access to 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.