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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06983808




Registration number
NCT06983808
Ethics application status
Date submitted
30/04/2025
Date registered
21/05/2025
Date last updated
21/05/2025

Titles & IDs
Public title
The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
Scientific title
The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
Secondary ID [1] 0 0
RMH-HREC 2024.163
Secondary ID [2] 0 0
RMIT-HREC 28861
Universal Trial Number (UTN)
Trial acronym
PREBEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Digital Cardiac Prehabilitation
Other interventions - Control (Standard treatment)

Active comparator: Control - Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians.

Experimental: Digital Health Arm - Patients in this arm engage in digital health prehabilitation which involves exercise, nutrition and information and scheduled telehealth to assist with preparation for surgery.


Other interventions: Digital Cardiac Prehabilitation
Digital Cardiac Prehabilitation - A combined telehealth and app-based preparation for cardiac surgery

Other interventions: Control (Standard treatment)
Standard preparation for surgery as per Melbourne Health hospital procedures and processes. This may include information sessions, pamphlets, and meetings with clinicians. This does not include a prehabilitation program.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
Timepoint [1] 0 0
2 days Pre-operatively
Primary outcome [2] 0 0
Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics
Timepoint [2] 0 0
2 days Pre-operatively
Primary outcome [3] 0 0
Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)
Timepoint [3] 0 0
2 days Pre-operatively
Primary outcome [4] 0 0
Incidence of Adverse events
Timepoint [4] 0 0
Recorded through study completion, an average of 7 months.
Secondary outcome [1] 0 0
Health service use as measured by Length of Stay (LOS)
Timepoint [1] 0 0
30 days post-operatively
Secondary outcome [2] 0 0
Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)
Timepoint [2] 0 0
30 days post-operatively
Secondary outcome [3] 0 0
Health service use as measured by Readmissions
Timepoint [3] 0 0
30 days post-operatively
Secondary outcome [4] 0 0
Health service use as measured by the Health Utilization Questionnaire (HUQ)
Timepoint [4] 0 0
Post operatively at Time Points: 2 weeks, 30 days, 3 months and 6 months
Secondary outcome [5] 0 0
Mortality as measured by days alive out of hospital (DAoH)
Timepoint [5] 0 0
6 months post-operatively
Secondary outcome [6] 0 0
Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff.
Timepoint [6] 0 0
6 months post-operatively
Secondary outcome [7] 0 0
Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS).
Timepoint [7] 0 0
Baseline, 2 days pre-operatively, Post operatively at Time Points: 1 day, 3 days, day of discharge, 2 weeks, 30 days, 3 months and 6 months.
Secondary outcome [8] 0 0
Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs)
Timepoint [8] 0 0
Baseline, 2 days pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, 3 months and 6 months.
Secondary outcome [9] 0 0
Body metrics as measured by Body Mass Index (BMI)
Timepoint [9] 0 0
Baseline, 3 months post-operatively.
Secondary outcome [10] 0 0
Body metrics as measured by Waist Hip Ratio (WHR)
Timepoint [10] 0 0
Baseline, 3 months post-operatively.
Secondary outcome [11] 0 0
Body composition (Bioimpedance) as measured by non-invasive tetrapolar bioimpedance spectroscopy (BIS, SOZO, Impedimed, USA).
Timepoint [11] 0 0
Baseline, 3 months post-operatively.
Secondary outcome [12] 0 0
Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS)
Timepoint [12] 0 0
Post operatively at Time Points: 1 day, 3 days, day of discharge.
Secondary outcome [13] 0 0
Functional capacity as measured by 1-Minute Sit-to-Stand (1STS)
Timepoint [13] 0 0
Baseline, 2 days pre-operatively, Post operatively at day of discharge, 3 months and 6 months.
Secondary outcome [14] 0 0
Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP)
Timepoint [14] 0 0
Baseline, 2 days pre-operatively, and 3 months post-operatively.
Secondary outcome [15] 0 0
Adherence to the Mediterranean diet as measured by The MEDAS (Mediterranean Diet Adherence Screener)
Timepoint [15] 0 0
Baseline, 2 days pre-operatively, Post operatively at day of discharge, 30 days, 3 months and 6 months.
Secondary outcome [16] 0 0
Anxiety as measured by The State-Trait Anxiety Inventory (STAI)
Timepoint [16] 0 0
Baseline, 2 days pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, 3 months and 6 months.
Secondary outcome [17] 0 0
Self-Efficacy as measured by The General Self-Efficacy Scale (GSE)
Timepoint [17] 0 0
Baseline, 2 days pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, 3 months and 6 months.

Eligibility
Key inclusion criteria
* 21 days+ prior to cardiac surgery
* Able to provide consent,
* Proficient in English to understand questionnaires, training instructions and outcome assessments.
* Digitally literate to independently navigate a smart device and novel application.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
* unstable psychiatric or cognitive disorders,

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health (Royal Melbourne and Melbourne Private Hospital) - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Claire Hines
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Alistair Royse, MD - Cardiothoracic Surgeon
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claire Hines, BSc, BA, M. Physiotherapy
Address 0 0
Country 0 0
Phone 0 0
+61404866816
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data summary from primary and secondary outcome measures

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
By at least Jan 2027, for at least 12 months.
Available to whom?
By Journal Article Publication and/or conference posters, proceedings and/or presentations.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06983808