Cardiovascular DiseasesPREBEATNCT06983808
The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
A study testing Digital Cardiac Prehabilitation in people with Cardiovascular Diseases, run by Claire Hines at 1 site in Australia.
Trial summary
The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are: 1. Is the digital health program usable? 2. Is the digital health program acceptable? 3. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Digital Cardiac Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
- unstable psychiatric or cognitive disorders,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deputy Dean, Engagement Health and Biomedical Sciences, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Melbourne Health (Royal Melbourne and Melbourne Private Hospital)
Melbourne, Victoria, 3050
Claire Hines, BSc, BA, M.Physiotherapy, +61404866816, claire.hines@mh.org.au
Alistair Royse, MD - Cardiothoracic Surgeon, +61393427000, alistair.royse@mh.org.au
About this study
The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are:
- Is the digital health program usable?
- Is the digital health program acceptable?
- Do patients adhere to the digital health program?
Read more
Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes.
Participants will
- Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery.
- Engage in telehealth consultations.
- Complete questionnaires
- Complete exercise testing
- Conditions
- Cardiovascular Diseases
- Being tested
- Digital Cardiac Prehabilitation, Control (Standard treatment)
- Keywords
- Digital Health, Telehealth, CABG, Cardiac Surgery, Heart Surgery, Prehabilitation, Perioperative
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cardiac PrehabilitationOther
Digital Cardiac Prehabilitation - A combined telehealth and app-based preparation for cardiac surgery
Control (Standard treatment)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians. Receives: Other: Control (Standard treatment) |
| Digital Health Arm | Experimental | Patients in this arm engage in digital health prehabilitation which involves exercise, nutrition and information and scheduled telehealth to assist with preparation for surgery. Receives: Other: Digital Cardiac Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
mAUQ is an 18-item questionnaire for patients to evaluate the usability of the digital application under the three domains of; Ease of Use, Interface, Satisfaction and Usefulness.
Low numbers indicate a higher perception of usability with the digital interface for participants.
Measured: 1 day Pre-operatively
Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics
Metrics Used include
- Time and date: when the application is accessed.
- Dwell Time: how much time is spent on a particular page.
- Number of pages viewed: how many views per page per day.
- User input data: data the user submits in the app, including minutes walked, exercises marked as complete, and questionnaires completed.
Measured: 1 day Pre-operatively
Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)
TFA-Q is composed of eight items, in alignment with the eight acceptability constructs (Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, general acceptability).
High numbers indicate a more acceptable digital experience.
Measured: 1 day Pre-operatively
Incidence of Adverse events
Adverse events, defined as any undesirable event, such as injury, fall, and discomfort related to prehabilitation will be recorded and severity will be reported according to hospital policy.
Lower numbers are more favourable, indicating fewer adverse events.
Measured: Recorded through study completion, an anticipated average of 4 months.
Secondary outcomes (15)
Health service use as measured by Length of Stay (LOS)
Hospital services use measured by length of stay (LOS) (days) - gained using hospital administrative data.
Low numbers are preferable, indicating the patient has not stayed as long in hospital.
Measured: 2 weeks post-operatively
Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)
Hospital services use as measured by ICU LOS (days), gained using hospital administrative data.
Low numbers are preferable, indicating the patient has not required as intensive care.
Measured: 2 weeks post-operatively
Mortality as measured by days alive out of hospital (DAoH)
Mortality as measured by days alive out of hospital. This data will be gained using hospital administrative records in the event that the patient is uncontactable.
DAoH should be equal to the number of days since discharge. Where DAoH are lower than the number of days since discharge, this is less favourable, indicating the patient has not survived.
Measured: 30 days post-operatively
Health service use as measured by Readmissions
Hospital services use as measured by the incidence of Readmissions, gained using hospital administrative data.
Low numbers are preferable, indicating the patient has had less need to return to hospital for care, following discharge.
Measured: 2 weeks, 30 days and 3 months post-operatively
Health service use as measured by the Health Utilization Questionnaire (HUQ)
The HUQ is 12 item survey which assesses the frequency and type of healthcare services accessed by individuals. It gathers data on medical visits, hospital stays, medication use, and other healthcare interactions to evaluate healthcare consumption, and includes modern communication systems of engaging with health care services.
Low numbers are preferable, indicating less need to engage with health services.
Measured: Assessed at Baseline, 1 day pre-operatively, then post-operatively at Time Points: 2 weeks, 30 days, and 3 months.
Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff.
Hospital administrative records will be used to supplement resource use data from surveys on consent from participants. In addition, the lead patient-facing researcher will maintain a clinician log, documenting time spent with each patient during the intervention phase to accurately represent the equivalent cost of the intervention. This is expected to include time used for adjusting or maintaining physical activity programs, and any interactions online, via phone, or telehealth. Cost of program delivery will be calculated on conclusion of the PREBEAT trial.
Low cost is preferable, indicating a potential financial benefit to health services which provide prehabilitation programs.
Measured: 3 months post-operatively
Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS).
Recovery will be assessed using the 5-domain the Post-Operative Quality of Recovery Scale (PostopQRS). This scale has been designed to quantify quality of recovery ((physiological, emotive, nociceptive, activities of daily living, cognitive and patient perspective) after surgery and anaesthesia. It is comprised of questions that objectively measure patient recovery over multiple time periods. This assessment has been validated and used extensively in the cardiac surgical population. The PostopQRS will be used to monitor multidomain recovery at pre and post intervention timepoints, postoperatively and throughout recovery.
Measured: Baseline, 1 day pre-operatively, Post operatively at Time Points: 1 day, 3 days, day of discharge, and 30 days.
Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs)
The Functional Difficulties Questionnaire shortened (FDQs) is a 10-item functional outcome measure which asks the participant to rate the difficulty they experience when completing a series of 10 upper limb and trunk activities by placing a mark along a 10cm line, with anchors indicating "no difficulty" and "maximum difficulty". For those activities that participants could not attempt whilst completing the questionnaire due to the institution sternal precautions, they are asked to think back to the last time they performed the task.
Individual scores, measured to the nearest centimetre (cm), are aggregated to form a total out of 130 with higher scores representing greater difficulty experienced during functional activities.
Measured: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, and 3 months.
Body metrics as measured by Body Mass Index (BMI)
Height (cm) and weight (kg) are taken and placed into the formula: BMI = weight (kg) / [height (m)]². BMI healthy range is 18.5-24.9, with patients being above this overweight (or obese if over 30).
Measured: Baseline, 3 months post-operatively.
Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS)
The Melbourne Group Score (MGS) is a clinical tool used to diagnose postoperative pulmonary complications (PPCs) in patients following surgery. It consists of a set of criteria including abnormal chest x-ray, fever, elevated white cell count, production of purulent sputum, positive respiratory culture, oxygen saturation below 90% on room air, and clinical signs of pulmonary infection.
If a patient has the presence of four or more criteria in a 24-hour period it is diagnostic of a PPC.
Lower numbers of PPC through the study are preferable, indicating a lower number of chest infections.
Measured: Post operatively at Time Points: 1 day, 3 days, day of discharge and 30 days
Functional capacity as measured by 1-Minute Sit-to-Stand (1STS)
The 1-Minute Sit-to-Stand (1STS) assessment is a simple, quick test used to evaluate lower body strength, endurance, and functional capacity. The participant is asked to stand up from a seated position and sit back down as many times as possible within one minute. The total number of repetitions is recorded as the score.
Higher scores indicate a better functional capacity.
Measured: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days and 3 months.
Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (MIP) is a measure of inspiratory muscle strength and will be measured via a maximal inspiratory effort using the Powerbreathe KH2. Patients will be asked to sit comfortably in a chair with their feet flat on the ground, with a nose clip on. Patient's will be asked to completely exhale, then form a secure lip seal around the mouthpiece and inhale as forcefully as possible through the device. The KH2 Powerbreathe will measure the pressure generated during this maximal inspiratory effort. This process will be repeated twice, with a 1-minute rest between efforts. The highest pressure generated will be recorded as the patient's MIP.
Higher pressures are preferable, indicating stronger inspiratory muscles.
Measured: Baseline, 1 day pre-operatively, and post-operatively at discharge.
Adherence to the Mediterranean diet as measured by The MEDAS (Mediterranean Diet Adherence Screener)
The MEDAS (Mediterranean Diet Adherence Screener) is a 14-item questionnaire designed to evaluate adherence to the Mediterranean diet. Each item assesses the frequency or amount of specific food consumption or dietary habits associated with the Mediterranean diet, such as olive oil, fruits, vegetables, nuts, fish, legumes, and wine. Points are assigned for each item, with higher scores indicating greater adherence to the diet.
Measured: Baseline, 1 day pre-operatively, Post operatively at 2 weeks, 30 days, and 3 months.
Anxiety as measured by The State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a 40 item psychological assessment tool that measures anxiety in adults and is commonly used in prehabilitation research. It distinguishes between two types of anxiety: state anxiety (a temporary condition experienced in specific situations) and trait anxiety (a general tendency to respond with anxiety across many situations). To reduce the patient assessment burden, the shorted version: State-Trait Anxiety Inventory (STAI-6) will be used in this study.
Lower scores are preferable, indicating a less anxious patient.
Measured: Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.
Self-Efficacy as measured by The General Self-Efficacy Scale (GSE)
The General Self-Efficacy Scale (GSE) is a 10-item questionnaire designed to assess an individual's belief in their ability to handle various stressful situations and challenges. Each item is rated on a 4-point Likert scale, ranging from "Not at all true" to "Exactly true." Higher scores indicate greater self-efficacy.
Measured: Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start28 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claire Hines
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health
- Responsible party
- Sponsor-investigator, Claire Hines, RMIT University
- Investigators
- Alistair Royse, MD - Cardiothoracic Surgeon, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983808
- Sponsor's protocol ID
- RMIT-HREC 28861
- Other IDs
- RMH-HREC 2024.163
- Acronym
- PREBEAT
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data summary from primary and secondary outcome measures
Publications
Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23.
PubMed 36149383Doyle MP, Indraratna P, Tardo DT, Peeceeyen SC, Peoples GE. Safety and efficacy of aerobic exercise commenced early after cardiac surgery: A systematic review and meta-analysis. Eur J Prev Cardiol. 2019 Jan;26(1):36-45. doi: 10.1177/2047487318798924. Epub 2018 Sep 6.
PubMed 30188177Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712.
PubMed 28801404Magon A, Caruso R, Sironi A, Mirabella S, Dellafiore F, Arrigoni C, Bonavina L. Trajectories of Health-Related Quality of Life, Health Literacy, and Self-Efficacy in Curatively-Treated Patients with Esophageal Cancer: A Longitudinal Single-Center Study in Italy. J Patient Exp. 2021 Nov 29;8:23743735211060769. doi: 10.1177/23743735211060769. eCollection 2021.
PubMed 35252557Nijkamp MD, Kenens CA, Dijker AJ, Ruiter RA, Hiddema F, Nuijts RM. Determinants of surgery related anxiety in cataract patients. Br J Ophthalmol. 2004 Oct;88(10):1310-4. doi: 10.1136/bjo.2003.037788.
PubMed 15377557Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.
PubMed 21508208Hulzebos EH, van Meeteren NL, van den Buijs BJ, de Bie RA, Brutel de la Riviere A, Helders PJ. Feasibility of preoperative inspiratory muscle training in patients undergoing coronary artery bypass surgery with a high risk of postoperative pulmonary complications: a randomized controlled pilot study. Clin Rehabil. 2006 Nov;20(11):949-59. doi: 10.1177/0269215506070691.
PubMed 17065538Birrer DL, Kuemmerli C, Obwegeser A, Liebi M, von Felten S, Pettersson K, Horisberger K. INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery. Trials. 2022 Jun 7;23(1):473. doi: 10.1186/s13063-022-06254-4.
PubMed 35672861Beaujolin, A., Mané, J., Presse, C., Barbosa-Silva, J., Bernini, M., Corbellini, C., & De Abreu, R. M. (2024). Inspiratory Muscle Training Intensity in Patients Living with Cardiovascular Diseases: A Systematic Review. Hearts, 5(1), 75-90.
Patsaki I, Kouvarakos A, Vasileiadis I, Koumantakis GA, Ischaki E, Grammatopoulou E, Kotanidou A, Magira EE. Low-Medium and High-Intensity Inspiratory Muscle Training in Critically Ill Patients: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2024 May 26;60(6):869. doi: 10.3390/medicina60060869.
PubMed 38929486Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
PubMed 30007823Ng DP, Thiviyan P, Shrida S, Ng LWC. Feasibility of Conducting Sit-to-Stand Tests Using Video Consultation. Int J Telemed Appl. 2023 Jul 26;2023:8551680. doi: 10.1155/2023/8551680. eCollection 2023.
PubMed 39280702Larrateguy S, Otto-Yanez M, Bogado J, Larrateguy L, Barros-Poblete M, Mazzucco G, Blanco I, Gimeno-Santos E, Torres-Castro R. Agreement and Reliability Between Tele-Assessment and In-Person Assessment of the One-Minute Sit-to-Stand Test in Patients with Chronic Respiratory Diseases. J Clin Med. 2025 Jul 16;14(14):5049. doi: 10.3390/jcm14145049.
PubMed 40725738Salling SL, Jensen JH, Mosegaard SB, Sorensen L, Mechlenburg I. Risk stratification for post-operative pulmonary complications following major cardiothoracic or abdominal surgery: Validation of the PPC Risk Prediction Score for physiotherapist's clinical decision-making. Clin Respir J. 2023 Mar;17(3):229-240. doi: 10.1111/crj.13579. Epub 2023 Jan 3.
PubMed 36596755Sedlmeier AM, Baumeister SE, Weber A, Fischer B, Thorand B, Ittermann T, Dorr M, Felix SB, Volzke H, Peters A, Leitzmann MF. Relation of body fat mass and fat-free mass to total mortality: results from 7 prospective cohort studies. Am J Clin Nutr. 2021 Mar 11;113(3):639-646. doi: 10.1093/ajcn/nqaa339.
PubMed 33437985
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
- ClinicalTrials.gov ID
- NCT06983808
- Acronym / sponsor ID
- PREBEAT / RMIT-HREC 28861
- Conditions
- Cardiovascular Diseases
- Keywords
- Digital Health, Telehealth, CABG, Cardiac Surgery, Heart Surgery, Prehabilitation, Perioperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Claire HinesUniversity, hospital or other
- Collaborators
- Melbourne Health
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomised controlled trial is to learn if a digital prehabilitation program is feasible in patients awaiting cardiac surgery. The main questions it aims to answer are:
- Is the digital health program usable?
- Is the digital health program acceptable?
- Do patients adhere to the digital health program?
Researchers will compare a group using the digital prehabilitation program with standard care to see if the program is feasible and explore any differences in health outcomes.
Participants will
- Use a digital health mobile phone application to guide you through exercise, nutrition and preparation for surgery.
- Engage in telehealth consultations.
- Complete questionnaires
- Complete exercise testing
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control (Standard treatment)Patients in this arm receive standard preparation for surgery as per hospital procedure. This may include information sessions, pamphlets, and meetings with clinicians. |
| Digital Health Arm | Experimental | Other: Digital Cardiac PrehabilitationPatients in this arm engage in digital health prehabilitation which involves exercise, nutrition and information and scheduled telehealth to assist with preparation for surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- severe or unstable neurological, cardiorespiratory, or musculoskeletal disease or mental illness that might compromise ability to perform exercise,
- unstable psychiatric or cognitive disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cardiac PrehabilitationDigital Cardiac Prehabilitation - A combined telehealth and app-based preparation for cardiac surgery | Other | Digital Health Arm |
| 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. | Other | Control |
Primary outcome
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
Time frame: 1 day Pre-operatively
mAUQ is an 18-item questionnaire for patients to evaluate the usability of the digital application under the three domains of; Ease of Use, Interface, Satisfaction and Usefulness. Low numbers indicate a higher perception of usability with the digital interface for participants.
Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics
Time frame: 1 day Pre-operatively
Metrics Used include * Time and date: when the application is accessed. * Dwell Time: how much time is spent on a particular page. * Number of pages viewed: how many views per page per day. * User input data: data the user submits in the app, including minutes walked, exercises marked as complete, and questionnaires completed.
Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)
Time frame: 1 day Pre-operatively
TFA-Q is composed of eight items, in alignment with the eight acceptability constructs (Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, general acceptability). High numbers indicate a more acceptable digital experience.
Incidence of Adverse events
Time frame: Recorded through study completion, an anticipated average of 4 months.
Adverse events, defined as any undesirable event, such as injury, fall, and discomfort related to prehabilitation will be recorded and severity will be reported according to hospital policy. Lower numbers are more favourable, indicating fewer adverse events.
15 secondary outcomes
Health service use as measured by Length of Stay (LOS)
Time frame: 2 weeks post-operatively
Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)
Time frame: 2 weeks post-operatively
Mortality as measured by days alive out of hospital (DAoH)
Time frame: 30 days post-operatively
Health service use as measured by Readmissions
Time frame: 2 weeks, 30 days and 3 months post-operatively
Health service use as measured by the Health Utilization Questionnaire (HUQ)
Time frame: Assessed at Baseline, 1 day pre-operatively, then post-operatively at Time Points: 2 weeks, 30 days, and 3 months.
Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff.
Time frame: 3 months post-operatively
Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS).
Time frame: Baseline, 1 day pre-operatively, Post operatively at Time Points: 1 day, 3 days, day of discharge, and 30 days.
Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs)
Time frame: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, and 3 months.
Body metrics as measured by Body Mass Index (BMI)
Time frame: Baseline, 3 months post-operatively.
Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS)
Time frame: Post operatively at Time Points: 1 day, 3 days, day of discharge and 30 days
Functional capacity as measured by 1-Minute Sit-to-Stand (1STS)
Time frame: Baseline, 1 day pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days and 3 months.
Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP)
Time frame: Baseline, 1 day pre-operatively, and post-operatively at discharge.
Adherence to the Mediterranean diet as measured by The MEDAS (Mediterranean Diet Adherence Screener)
Time frame: Baseline, 1 day pre-operatively, Post operatively at 2 weeks, 30 days, and 3 months.
Anxiety as measured by The State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.
Self-Efficacy as measured by The General Self-Efficacy Scale (GSE)
Time frame: Baseline, 1 day pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, and 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 36149383Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, Walther C. Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Apr 1;102(4):323-330. doi: 10.1097/PHM.0000000000002097. Epub 2022 Sep 23.
- Background: PubMed 30188177Doyle MP, Indraratna P, Tardo DT, Peeceeyen SC, Peoples GE. Safety and efficacy of aerobic exercise commenced early after cardiac surgery: A systematic review and meta-analysis. Eur J Prev Cardiol. 2019 Jan;26(1):36-45. doi: 10.1177/2047487318798924. Epub 2018 Sep 6.
- Background: PubMed 28801404Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712.
- Background: PubMed 35252557Magon A, Caruso R, Sironi A, Mirabella S, Dellafiore F, Arrigoni C, Bonavina L. Trajectories of Health-Related Quality of Life, Health Literacy, and Self-Efficacy in Curatively-Treated Patients with Esophageal Cancer: A Longitudinal Single-Center Study in Italy. J Patient Exp. 2021 Nov 29;8:23743735211060769. doi: 10.1177/23743735211060769. eCollection 2021.
- Background: PubMed 15377557Nijkamp MD, Kenens CA, Dijker AJ, Ruiter RA, Hiddema F, Nuijts RM. Determinants of surgery related anxiety in cataract patients. Br J Ophthalmol. 2004 Oct;88(10):1310-4. doi: 10.1136/bjo.2003.037788.
- Background: PubMed 21508208Schroder H, Fito M, Estruch R, Martinez-Gonzalez MA, Corella D, Salas-Salvado J, Lamuela-Raventos R, Ros E, Salaverria I, Fiol M, Lapetra J, Vinyoles E, Gomez-Gracia E, Lahoz C, Serra-Majem L, Pinto X, Ruiz-Gutierrez V, Covas MI. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr. 2011 Jun;141(6):1140-5. doi: 10.3945/jn.110.135566. Epub 2011 Apr 20.
- Background: PubMed 17065538Hulzebos EH, van Meeteren NL, van den Buijs BJ, de Bie RA, Brutel de la Riviere A, Helders PJ. Feasibility of preoperative inspiratory muscle training in patients undergoing coronary artery bypass surgery with a high risk of postoperative pulmonary complications: a randomized controlled pilot study. Clin Rehabil. 2006 Nov;20(11):949-59. doi: 10.1177/0269215506070691.
- Background: PubMed 35672861Birrer DL, Kuemmerli C, Obwegeser A, Liebi M, von Felten S, Pettersson K, Horisberger K. INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery. Trials. 2022 Jun 7;23(1):473. doi: 10.1186/s13063-022-06254-4.
- BackgroundBeaujolin, A., Mané, J., Presse, C., Barbosa-Silva, J., Bernini, M., Corbellini, C., & De Abreu, R. M. (2024). Inspiratory Muscle Training Intensity in Patients Living with Cardiovascular Diseases: A Systematic Review. Hearts, 5(1), 75-90.
- Background: PubMed 38929486Patsaki I, Kouvarakos A, Vasileiadis I, Koumantakis GA, Ischaki E, Grammatopoulou E, Kotanidou A, Magira EE. Low-Medium and High-Intensity Inspiratory Muscle Training in Critically Ill Patients: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2024 May 26;60(6):869. doi: 10.3390/medicina60060869.
- Background: PubMed 30007823Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
- Background: PubMed 39280702Ng DP, Thiviyan P, Shrida S, Ng LWC. Feasibility of Conducting Sit-to-Stand Tests Using Video Consultation. Int J Telemed Appl. 2023 Jul 26;2023:8551680. doi: 10.1155/2023/8551680. eCollection 2023.
- Individual participant dataSharing planned: Yes. De-identified data summary from primary and secondary outcome measures
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deputy Dean, Engagement Health and Biomedical Sciences, PhD contact
Alistair Royse, MD - Cardiothoracic Surgeon principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cardiac Prehabilitation in people with Cardiovascular Diseases, run by Claire Hines at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Hines, BSc, BA, M. Physiotherapy (+61404866816, claire.hines@rmit.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ) (time frame: 1 day Pre-operatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983808, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.