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Trial registered on ANZCTR
Registration number
ACTRN12625000039482p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Selection of Patients undergoing Transcatheter Aortic Valve Replacement (TAVR) for Rehabilitation: A pilot study
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Scientific title
Selection of Patients undergoing Transcatheter AVR for Rehabilitation: A pilot study exploring the effects of a three month cardiac rehabilitation program on frailty in patients post transcatheter AVR.
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Secondary ID [1]
313558
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None
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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:
Severe aortic stenosis
336064
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Condition category
Condition code
Cardiovascular
332615
332615
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Non-drug trial.
Primary intervention: a three month cardiac rehabilitation program. This will be delivered in two phases - phase 1 (weeks 0-8) - supervised, 2 x weekly 60 minute individualised exercise sessions supervised and delivered by an Accredited Exercise Physiologist (AEP) on-site at a gym in a medical research facility. These sessions will be on non-consecutive days, with at least 1 day rest in between. Phase 2 (weeks 8-12) - telehealth, 1 x weekly sessions from the participant's home to provide ongoing support and advice re: exercise and lifestyle. These sessions will run for 30-60 minutes depending on the needs of the participant.
The AEP delivering the study will have minimum 5 years clinical experience working with cardiovascular patients and accredited with the governing body of Exercise & Sports Science Australia (ESSA). In addition they will have up to date first aid and CPR qualifications.
The exercise intervention will be personalised for each person depending on their other medical conditions, exercise history and baseline testing (muscular endurance, submaximal fitness, etc). It will be based on best practice for patients post valve replacements using the guidelines listed in the CSANZ Position Statement on Prescription of Exercise in Cardiac Rehabilitation (Verdicchio et al., 2023). The intervention will include both aerobic and strength exercise. Examples of aerobic exercise include recumbent or upright cycling and treadmill (if appropriate). Examples of strength exercises include sit to stand, seated banded leg extensions, calf raises, dumbbell bicep curls and seated theraband rows.
Exercise adherence in Phase 1 will be monitored by recording session attendance in an online database. In Phase 2, participants will be provided with a wearable fitness tracker (Polar Flow watch) to record their exercise session type and duration. The AEP will have access to their session data and will record this in an online database.
This study will be conducted in patients 65 years old and above who have undergone a TAVR within the last three 6 months. Ideally participants will be recruited within 1-2 weeks post TAVR if deemed medically stable by the cardiologist and no post-operative complications have occurred. The research team will seek to commence the cardiac rehabilitation program for each participant as soon as possible after the baseline visit, noting that best practice for cardiac rehabilitation is early initiation after an event or hospitalisation.
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Intervention code [1]
330150
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Behaviour
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Intervention code [2]
330149
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Lifestyle
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Intervention code [3]
330148
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Rehabilitation
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340134
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Primary outcome: a change in frailty, as determined by change in six minute walk test (6MWT) gait speed and distance across the three defined time points (baseline, three months, six months). This is a composite primary outcome - the two are interrelated. An increase in 6MWT distance can only occur if gait speed has also increased, as you measure how far someone can walk within six minutes (which is determined by how fast they walk).
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Assessment method [1]
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Change in 6MWT gait speed and distance.
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Timepoint [1]
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Baseline, three months and six months post-baseline.
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Secondary outcome [1]
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Frailty
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Assessment method [1]
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FRAIL questionnaire.
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Timepoint [1]
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Baseline, three months and six months post-baseline.
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Secondary outcome [2]
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Change in hand grip strength.
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Assessment method [2]
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Handheld dynamometer.
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Timepoint [2]
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Baseline, three months and six months post-baseline.
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Eligibility
Key inclusion criteria
1. Ability and willingness to provide written informed consent to participate in the study
2. Safety - Adequate mobility (six minute walk test distance (6MWT) >100m), medical clearance from the referring cardiologist to exercise
3. Feasibility - Ability to attend eight weeks of supervised cardiac rehabilitation, and live within a geographically accessible area for follow-upPhase 1 (8 weeks) of supervised cardiac rehabilitation, and live within a geographically accessible area for follow-up
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Minimum age
65
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
1. The inability or willingness to provide written informed consent to participate in this study
2. Complications post TAVR e.g. infection or New York Heart Association (NYHA) Class IV heart failure
3. Other physical disability (non-cardiac) that would deem exercise participation unsafe
4. Active malignancy or other medical conditions resulting in a life expectancy < 12 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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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
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Recruitment hospital [1]
27407
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Royal Hobart Hospital - Hobart
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Recruitment postcode(s) [1]
43520
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7000 - Hobart
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Funding & Sponsors
Funding source category [1]
318021
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Hospital
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Name [1]
318021
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Royal Hobart Hospital Research Foundation
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Address [1]
318021
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Country [1]
318021
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Australia
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Primary sponsor type
University
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Name
University of Tasmania
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Address
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Country
Australia
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Secondary sponsor category [1]
320363
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Hospital
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Name [1]
320363
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Royal Hobart Hospital
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Address [1]
320363
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Country [1]
320363
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316679
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University of Tasmania Human Research Ethics Committee
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Ethics committee address [1]
316679
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http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu
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Ethics committee country [1]
316679
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Australia
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Date submitted for ethics approval [1]
316679
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26/10/2024
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Approval date [1]
316679
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Ethics approval number [1]
316679
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Summary
Brief summary
This study seeks to improve mid to long term outcomes and reduce frailty in post-TAVR patients by implementing a 3-month CR program in an outpatient setting which will include individualised exercise and education. The proposed study aims to provide a model of care that can be implemented in future community settings. Study hypothesis: 1) Patients who engage in outpatient exercise training program will have reduced frailty at six-months post-TAVR, and 2) patients who benefit most can be predicted.
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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
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Prof Tom Marwick
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Address
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Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
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Country
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Australia
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Phone
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+61427157975
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Fax
138638
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Email
138638
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[email protected]
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Contact person for public queries
Name
138639
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Kittani Morrison
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Address
138639
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Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
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Country
138639
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Australia
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Phone
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+61 0362268410
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Fax
138639
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Email
138639
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[email protected]
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Contact person for scientific queries
Name
138640
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Kittani Morrison
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Address
138640
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Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
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Country
138640
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Australia
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Phone
138640
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+61 0362268410
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Fax
138640
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Email
138640
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[email protected]
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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.
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