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Trial registered on ANZCTR


Registration number
ACTRN12622000872730
Ethics application status
Approved
Date submitted
14/06/2022
Date registered
20/06/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
20/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing telehealth delivery of phase III cardiac rehabilitation in regional Australia: rationale and design for a non-inferiority trial.
Scientific title
Assessing telehealth delivery of phase III cardiac rehabilitation in regional Australia: rationale and design for a non-inferiority trial.
Secondary ID [1] 307340 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 326631 0
Condition category
Condition code
Cardiovascular 323876 323876 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-week single-blinded, two-arm parallel, randomized non-inferiority trial will be conducted. Baseline testing will include completing health questionnaires, Holter heart rate monitoring and blood sampling, before participants are randomly allocated an onsite (arm 1) or telehealth (arm 2) delivered training intervention. The training sessions will be delivered individually via telehealth using a combination of audio and audio-video monitoring or supervised (on-site) in a group exercise setting by qualified personnel with previous experience in implementing training programs. Exercise prescription will be standardized between groups as aerobic exercise that can be completed on stationary cycle ergometers or treadmill (on-site) with telehealth group advised to use aerobic modes at their disposal (most likely walking or jogging). Telehealth participants will be required to log their training sessions (total time and intensity reported as average heart rate) using heart rate monitors provided by the research team via online exercise app (Polar Flow). Training prescription: six (6) weeks, three (3) sessions per week of aerobic exercise conducted at a workload equivalent to the ventilatory anaerobic threshold (determined from cardiopulmonary exercise test in baseline testing). Total session time, including standardized warm up and cool down will be 60 minutes. Upon completion of training both groups will return for post-intervention testing consisting of the same baseline measures conducted in a standardized manner.
Intervention code [1] 323774 0
Lifestyle
Intervention code [2] 323800 0
Prevention
Comparator / control treatment
Supervised exercise intervention (conducted on-site in university clinic) will act as a control for standard cardiac rehabilitation delivery in comparison to a telehealth protocol. A maximum of 8 participants will be supervised in group training sessions at any one time (per trainer). The prescribed exercise dose (intensity, frequency and duration) will be identical between interventions. There will be no 'non-exercise' control comparator
Control group
Active

Outcomes
Primary outcome [1] 331688 0
Change in cardiorespiratory fitness as assessed by cardiopulmonary exercise test (CPET). Respiratory metabolism will be measured using open-circuit spirometry with a mixing chamber based metabolic system
Timepoint [1] 331688 0
Within seven (7) days prior commencement of intervention and within seven (7) days post final intervention session
Secondary outcome [1] 410792 0
Heart rate variability. Data collected using 5-lead Holter monitor with offline assessment of time and frequency domain
Timepoint [1] 410792 0
Within seven (7) days prior commencement of intervention and within seven (7) days post final intervention session
Secondary outcome [2] 410793 0
Lipid profile using intravenous blood sampling and commercially available analysis
Timepoint [2] 410793 0
Within seven (7) days prior commencement of intervention and within seven (7) days post final intervention session
Secondary outcome [3] 422476 0
Sleep quality assessed as a 7-day average using wrist worn actigraphy watch
Timepoint [3] 422476 0
Seven (7) days prior to program commencement and collected with five (5) days of project completion.
Secondary outcome [4] 422477 0
Training fidelity: Participants will wear heart rate monitors during each training session, logged by the supervising team for on-site participants and via Polar Flow for telehealth group. Fidelity will be calculated as a combination of training compliance (the percentage of exercise performed at the prescribed intensity for the prescribed duration) and adherence (the percentage of weekly sessions of exercise attended by each participant).
Timepoint [4] 422477 0
Data is collected throughout the intervention
Secondary outcome [5] 422478 0
Pulse Wave Velocity (PWV) to analyze arterial stiffness
Timepoint [5] 422478 0
Within seven (7) days prior to commencement of intervention and within seven (7) days post final intervention session

Eligibility
Key inclusion criteria
Age 18 years or older
Efficient verbal English Skills
Diagnosed with cardiovascular disease
Exiting in-patient cardiac rehabilitation
Physically able to complete exercise testing
Available to meet the time commitments
Access to a phone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with heart failure or hypertrophic myopathy
Heart transplant participants
Unstable angina or myocardial infarction < 1 month

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be conducted by independent researcher who is 'off-site'
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Non-inferiority Trial:
If there is truly no difference between the standard and experimental treatment with a population standard deviation of 3.1 ml.kg.min-1, then 13 participants are required in each arm (26 participants in total) to be 80% sure that the lower limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will be above the non-inferiority limit of -3.5 ml.kg.min-1. One metabolic equivalent (3.5 ml.kg.min-1) was considered the minimum clinical difference (non-inferiority limit) due to its association with reduced cardiovascular mortality. To allow for up to 50% participant dropout rate, the initial target is to recruit 50 participants. Non-inferiority of telehealth ExCRP compared with ‘usual care’ supervised ExCRP will be tested using two one-sided T-tests (TOST procedure) with a p value of <0.025 required for statistical significance. Telehealth ExCRP will be concluded non-inferior to supervised ExCRP if the lower bound of the 95% CI for the mean difference in changes at post testing is less than 3.5 ml.kg.min-1.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/08/2022
Actual
22/09/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
12/08/2024
Actual
Sample size
Target
50
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22551 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [2] 22552 0
St John of God Hospital - Bendigo - Bendigo
Recruitment postcode(s) [1] 37790 0
3550 - Bendigo
Recruitment postcode(s) [2] 37791 0
3450 - Castlemaine
Recruitment postcode(s) [3] 37792 0
3463 - Maldon
Recruitment postcode(s) [4] 37793 0
3551 - Axedale

Funding & Sponsors
Funding source category [1] 311631 0
Charities/Societies/Foundations
Name [1] 311631 0
Holsworth Research Initiative
Country [1] 311631 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Edwards Road, Flora Hill
Victoria 3550
Country
Australia
Secondary sponsor category [1] 313068 0
Hospital
Name [1] 313068 0
Bendigo Health
Address [1] 313068 0
100 Bernard Street,
Bendigo, VIC, 3550
Country [1] 313068 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311088 0
Bendigo Health HREC
Ethics committee address [1] 311088 0
Ethics committee country [1] 311088 0
Australia
Date submitted for ethics approval [1] 311088 0
23/12/2021
Approval date [1] 311088 0
01/07/2022
Ethics approval number [1] 311088 0
LNR21BH81083

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

Contacts
Principal investigator
Name 119898 0
Dr Blake Collins
Address 119898 0
La Trobe University,
Edwards Road, Flora Hill
Victoria, 3550
Country 119898 0
Australia
Phone 119898 0
+61 3 5444 7144
Fax 119898 0
Email 119898 0
[email protected]
Contact person for public queries
Name 119899 0
Blake Collins
Address 119899 0
La Trobe University,
Edwards Road, Flora Hill
Victoria, 3550
Country 119899 0
Australia
Phone 119899 0
+61 3 5444 7144
Fax 119899 0
Email 119899 0
[email protected]
Contact person for scientific queries
Name 119900 0
Blake Collins
Address 119900 0
La Trobe University,
Edwards Road, Flora Hill
Victoria, 3550
Country 119900 0
Australia
Phone 119900 0
+61 3 5444 7144
Fax 119900 0
Email 119900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable participant demographic data , pre- and post-data and training intervention data will be made available
When will data be available (start and end dates)?
Within 12-months of publication with no end-date
Available to whom?
Data will be made publicly available, members of the public and those within research communities will have access to both published and unpublished data which will not be identifiable
Available for what types of analyses?
Any purpose. There is potential for follow-up research including re-analyses, systematic review and meta-analyses however this will not be apparent until the data is collected and analyses
How or where can data be obtained?
Published on OPAL (La Trobe institutional repository): https://opal.latrobe.edu.au
Or made available to researchers upon reasonable request with contact directed to [email protected]


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.