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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
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Scientific title
Evaluating a telehealth exercise model of care for adults with Cystic Fibrosis: A feasibility randomised controlled trial
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Secondary ID [1]
313677
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
336249
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Condition category
Condition code
Human Genetics and Inherited Disorders
332790
332790
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0
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Cystic fibrosis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330270
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Audit of study session attendance Intervention Option A: Completion of weekly check in session with physiotherapist (1 session per week for 12 weeks). Intervention Option B: Attendance at the live supervised exercise session (two sessions per week for 12 weeks).
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Timepoint [1]
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12 weeks (post intervention period)
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Secondary outcome [1]
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Safety: Number of adverse events that occur in participants related to participation in the telehealth exercise program.
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Assessment method [1]
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Any adverse events will be recorded in the adverse event log rated by severity. This data will be analysed and reported descriptively. Adverse events will be defined as any unfavourable unintended diagnosis, symptom, syndrome or disease that occurs during the study period that was absent at baseline, or made to worsen during the study. A serious adverse event will be defined as an adverse event that leads to: - Death - Serious deterioration in health that results in life threatening illness or injury, permanent impairment of a body structure or body function, or hospitalisation or prolongation of existing hospitalisation - Medical or surgical intervention required to prevent life threatening illness All adverse events and serious adverse events will be recorded on the adverse event log. Each adverse event will also be classified based on severity and how related it likely was to the study intervention or assessment measures. Assessment of severity: · Low: Event easily tolerated by the patient that caused minimal discomfort and did not interfere with their daily activities. · Moderate: Event that caused discomfort, leading to a reduced ability to complete normal daily activities. · Severe: Event that caused discomfort, leading to being unable to complete normal daily activities. · Life threatening: Event that had life threatening consequences. · Fatal: Event resulted in death. Assessment of the relatedness of the adverse event: · Not related: There is no evidence to suggest that the event was related to the intervention. · Unlikely: There is little evidence to suggest that the event was related to the intervention. There is another explanation for the event. · Possible: There is some evidence to suggest that there is a relationship between the event and the intervention. However there may be other factors that could have contributed to the event. If relatedness cannot be assessed or no information has been sourced then it should also be classified in this category. · Probable: The relationship between the intervention and the event seems relevant. The event cannot be explained by another cause. · Definitely: There is clear evidence to suggest that there is a relationship between the intervention and the event. Other possible contributing factors have been ruled out.
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Timepoint [1]
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Adverse events will be recorded throughout the study period (0-12 weeks) and assessed at the end of week 12 (post intervention period).
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Secondary outcome [2]
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Recruitment: Number of eligible participants who consent to take part in the study
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Assessment method [2]
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Data will be assessed via audit of trial screening records and reported as numerical data and proportions/percentages. Number of participants who consent to take part in the study as a proportion of the total number of eligible participants approached to take part in the study.
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Timepoint [2]
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This data will be collected throughout the study recruitment period and assessed at the end of the study recruitment period.
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Secondary outcome [3]
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Completion of follow up: Number of participants who attend two face-to-face assessments
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Assessment method [3]
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Data will be assessed via audit of trial screening records and reported as numerical data and proportions/percentages. Number of participants who complete the initial and final assessments face-to-face as a proportion of the total number of participants consented to this study. Between group differences (Control vs. Intervention) will also be analysed and reported.
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Timepoint [3]
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12 weeks (post intervention)
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Secondary outcome [4]
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Intervention preference: Number of participants who choose each intervention option in the telehealth exercise intervention model of care (Option A or Option B)
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Assessment method [4]
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Data will be assessed via audit of trial screening records and reported as numerical data and proportions/percentages. The intervention preference will be reported as the number of participants in the intervention group who select Option A versus Option B.
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Timepoint [4]
443694
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Baseline
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Secondary outcome [5]
443695
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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.
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Assessment method [5]
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Data will be assessed via audit of trial screening records and reported as numerical data and proportions/percentages. The assessment preference will be reported as the number of participants who complete each outcome measure. The following data will be analysed: The number of participants who complete: · ASTEP only · MST-25 only · 6MWT only · Both A-STEP and MST-25
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Timepoint [5]
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Baseline and end intervention assessment time point.
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Secondary outcome [6]
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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).
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Assessment method [6]
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The results from the Telehealth Satisfaction Scale (TeSS) will be analysed and reported as mean (standard deviations) related to the check in sessions via telehealth (option A) and the telehealth exercise program via zoom (Option B).
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Timepoint [6]
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End of intervention assessment (12 weeks)
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Secondary outcome [7]
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Usability: Usability of the peer support group measured by the System Usability Scale (SUS).
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Assessment method [7]
443698
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The results of the System Usability Scale (SUS) questionnaire will be analysed and reported as mean (standard deviations).
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Timepoint [7]
443698
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End of intervention assessment time point (12 weeks)
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Secondary outcome [8]
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Clinical change: Change in MST-25 distance at baseline and after program completion.
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Assessment method [8]
443699
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Data will be reported as mean (standard deviations) or median interquartile range (IQR) if not normally distributed. Between group and within group differences will be explored using appropriate parametric or non-parametric tests.
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Timepoint [8]
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Baseline and 12 weeks (post intervention).
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Secondary outcome [9]
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Clinical change: Change in A-STEP level at baseline and after program completion
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Assessment method [9]
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Data will be reported as mean (standard deviations) or median interquartile range (IQR) if not normally distributed. Between group and within group differences will be explored using appropriate parametric or non-parametric tests.
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Timepoint [9]
443872
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Baseline and 12 weeks (post intervention)
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Secondary outcome [10]
443873
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Clinical change: Change in AWESCORE at baseline and after program completion.
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Assessment method [10]
443873
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Data will be reported as mean (standard deviations) or median interquartile range (IQR) if not normally distributed. Between group and within group differences will be explored using appropriate parametric or non-parametric tests.
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Timepoint [10]
443873
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Baseline and 12 weeks (post intervention)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
10/04/2025
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Date of last participant enrolment
Anticipated
22/09/2025
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Actual
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Date of last data collection
Anticipated
22/12/2025
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Actual
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Sample size
Target
30
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
318140
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Hospital
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Name [1]
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Alfred Hospital Physiotherapy Department Senior Physiotherapist Research Fellowship
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
320523
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None
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Name [1]
320523
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Address [1]
320523
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Country [1]
320523
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316785
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
316785
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
316785
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Australia
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Date submitted for ethics approval [1]
316785
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24/10/2024
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Approval date [1]
316785
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15/11/2024
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Ethics approval number [1]
316785
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Project Number: 110261 (Local Reference: Project 630/24)
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Summary
Brief summary
Physical activity and exercise are important in the treatment of Cystic Fibrosis (CF) and delivering exercise programs via telehealth for people with CF may minimise the risk of cross infection and increase access to exercise. We asked adults with CF what they wanted to include in a telehealth exercise program and together we designed a new telehealth exercise model of care which will be tested in this project. Adults with CF from the Alfred Hospital will be invited to be part of this study which will run for 12 weeks. Participants will be put into an intervention or a control group by chance (at random). Participants in the control group will continue with their usual care such as appointments with their health care team. Participants who are allocated to the intervention group will receive their usual care and take part in the new telehealth model of care. In this intervention group, participants will be given the choice of attending a live supervised exercise group online, or completing an exercise program which they follow themselves with one-to-one check in sessions via telehealth with a Physiotherapist. The main outcome of this study will be to understand whether it is feasible to deliver a telehealth exercise model of care for people with CF.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139006
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Prof Anne Holland
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Address
139006
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The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
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Country
139006
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Australia
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Phone
139006
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+61 0419379821
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Fax
139006
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Email
139006
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[email protected]
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Contact person for public queries
Name
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Meg Poulsen
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Address
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The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
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Country
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Australia
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Phone
139007
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+61 418549111
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Fax
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Email
139007
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[email protected]
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Contact person for scientific queries
Name
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Anne Holland
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Address
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The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
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Country
139008
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Australia
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Phone
139008
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+61 0419379821
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Fax
139008
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Email
139008
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[email protected]
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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?
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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?
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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:
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Where can requests to access individual participant data be made, or data be obtained directly?
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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.
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