Trial Review

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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
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.
Secondary ID [1] 313558 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe aortic stenosis 336064 0
Condition category
Condition code
Cardiovascular 332615 332615 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330150 0
Behaviour
Intervention code [2] 330149 0
Lifestyle
Intervention code [3] 330148 0
Rehabilitation
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340134 0
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).
Timepoint [1] 340134 0
Baseline, three months and six months post-baseline.
Secondary outcome [1] 443115 0
Frailty
Timepoint [1] 443115 0
Baseline, three months and six months post-baseline.
Secondary outcome [2] 442909 0
Change in hand grip strength.
Timepoint [2] 442909 0
Baseline, three months and six months post-baseline.

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 27407 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 43520 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 318021 0
Hospital
Name [1] 318021 0
Royal Hobart Hospital Research Foundation
Country [1] 318021 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 320363 0
Hospital
Name [1] 320363 0
Royal Hobart Hospital
Address [1] 320363 0
Country [1] 320363 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316679 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 316679 0
Ethics committee country [1] 316679 0
Australia
Date submitted for ethics approval [1] 316679 0
26/10/2024
Approval date [1] 316679 0
Ethics approval number [1] 316679 0

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

Contacts
Principal investigator
Name 138638 0
Prof Tom Marwick
Address 138638 0
Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
Country 138638 0
Australia
Phone 138638 0
+61427157975
Fax 138638 0
Email 138638 0
[email protected]
Contact person for public queries
Name 138639 0
Kittani Morrison
Address 138639 0
Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
Country 138639 0
Australia
Phone 138639 0
+61 0362268410
Fax 138639 0
Email 138639 0
[email protected]
Contact person for scientific queries
Name 138640 0
Kittani Morrison
Address 138640 0
Menzies Institute for Medical Research. 17 Liverpool Street, Hobart, Tasmania, 7000
Country 138640 0
Australia
Phone 138640 0
+61 0362268410
Fax 138640 0
Email 138640 0
[email protected]

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.