Clinical trial NCT06983808: The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
Official title: The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Digital Health
Telehealth
CABG
Cardiac Surgery
Heart Surgery
Prehabilitation
Perioperative
Lead sponsor: RMIT University
Sponsor class: OTHER
Collaborators: name: Melbourne Health
First posted: 2025-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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


Eligibility criteria: 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.

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,

Primary outcomes:
measure: Usability of Digital Cardiac Prehabilitation as assessed by the Mhealth Application Usability Questionnaire (MAUQ)
timeFrame: 2 days Pre-operatively
measure: Adherence of Digital Cardiac Prehabilitation as measured by usage metrics from Mobile Phone App metrics
timeFrame: 2 days Pre-operatively
measure: Acceptability of Digital Cardiac Prehabilitation as measured by Theoretical Framework of Acceptability Questionnaire (TFA)
timeFrame: 2 days Pre-operatively
measure: Incidence of Adverse events
timeFrame: Recorded through study completion, an average of 7 months.
Secondary outcomes:
measure: Health service use as measured by Length of Stay (LOS)
timeFrame: 30 days post-operatively
measure: Health service use as measured by Intensive Care Unit (ICU) Length of Stay (ICU LOS)
timeFrame: 30 days post-operatively
measure: Health service use as measured by Readmissions
timeFrame: 30 days post-operatively
measure: Health service use as measured by the Health Utilization Questionnaire (HUQ)
timeFrame: Post operatively at Time Points: 2 weeks, 30 days, 3 months and 6 months
measure: Mortality as measured by days alive out of hospital (DAoH)
timeFrame: 6 months post-operatively
measure: Cost of program delivery as estimated by multiplying the occasions of service by relevant national average hospital award wages for respective staff.
timeFrame: 6 months post-operatively
measure: Recovery as measured by the Post-Operative Quality of Recovery Scale (PostopQRS).
timeFrame: 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.
measure: Functional outcome as measured by the Functional Difficulties Questionnaire shortened (FDQs)
timeFrame: Baseline, 2 days pre-operatively, Post operatively at day of discharge, 2 weeks, 30 days, 3 months and 6 months.
measure: Body metrics as measured by Body Mass Index (BMI)
timeFrame: Baseline, 3 months post-operatively.
measure: Body metrics as measured by Waist Hip Ratio (WHR)
timeFrame: Baseline, 3 months post-operatively.
measure: Body composition (Bioimpedance) as measured by non-invasive tetrapolar bioimpedance spectroscopy (BIS, SOZO, Impedimed, USA).
timeFrame: Baseline, 3 months post-operatively.
measure: Postoperative pulmonary complications (PPCs) as measured the Melbourne Group Score (MGS)
timeFrame: Post operatively at Time Points: 1 day, 3 days, day of discharge.
measure: Functional capacity as measured by 1-Minute Sit-to-Stand (1STS)
timeFrame: Baseline, 2 days pre-operatively, Post operatively at day of discharge, 3 months and 6 months.
measure: Inspiratory muscle strength as measured by Maximal Inspiratory Pressure (MIP)
timeFrame: Baseline, 2 days pre-operatively, and 3 months post-operatively.
measure: Adherence to the Mediterranean diet as measured by The MEDAS (Mediterranean Diet Adherence Screener)
timeFrame: Baseline, 2 days pre-operatively, Post operatively at day of discharge, 30 days, 3 months and 6 months.
measure: Anxiety as measured by The State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 2 days pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, 3 months and 6 months.
measure: Self-Efficacy as measured by The General Self-Efficacy Scale (GSE)
timeFrame: Baseline, 2 days pre-operatively, Post operatively at the day of discharge, 2 weeks, 30 days, 3 months and 6 months.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Health (Royal Melbourne and Melbourne Private Hospital)
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Alistair Royse, MD - Cardiothoracic Surgeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Doyle 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.
citation: Kehler 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.
citation: Magon 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.
citation: Nijkamp 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.
citation: Schroder 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.
citation: Hulzebos 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.
citation: Birrer 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.
citation: Beaujolin, 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.
citation: 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.
citation: Bissett 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.
citation: Ng 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.
citation: Larrateguy, S., Otto-Yañes, M., Bogado, J., Larrateguy, L., Blanco, I., Gimeno-Santos, E., & Torres-Castro, R. (2023). Reliability of remote 1-minute sit-to-stand test to measure physical capacity in patients with chronic respiratory diseases. Rehabilitation and Chronic Care
citation: Salling 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.
citation: Sedlmeier 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.
citation: Cao Q, Yu S, Xiong W, Li Y, Li H, Li J, Li F. Waist-hip ratio as a predictor of myocardial infarction risk: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Jul;97(30):e11639. doi: 10.1097/MD.0000000000011639.
citation: Sturgess, T. R., Denehy, L., Tully, E. A., McManus, M., Katijjahbe, M. A., & El-Ansary, D. (2018). The Functional Difficulties Questionnaire: A New Tool for Assessing Physical Function of the Thoracic Region in a Cardiac Surgery Population. Cardiopulmonary Physical Therapy Journal, 29(3), 110-123.
citation: Katijjahbe MA, Denehy L, Granger CL, Royse A, Royse C, Logie S, Sturgess T, Md Ali NA, McManus M, Sandy CE, El-Ansary D. Psychometric evaluation of the shortened version of the Functional Difficulties Questionnaire to assess thoracic physical function. Clin Rehabil. 2020 Jan;34(1):132-140. doi: 10.1177/0269215519879476. Epub 2019 Oct 15.
citation: Bowyer AJ, Heiberg J, Sessler DI, Newman S, Royse AG, Royse CF. Validation of the cognitive recovery assessments with the Postoperative Quality of Recovery Scale in patients with low-baseline cognition. Anaesthesia. 2018 Nov;73(11):1382-1391. doi: 10.1111/anae.14402. Epub 2018 Aug 7.
citation: Diab MS, Bilkhu R, Soppa G, Edsell M, Fletcher N, Heiberg J, Royse C, Jahangiri M. The influence of prolonged intensive care stay on quality of life, recovery, and clinical outcomes following cardiac surgery: A prospective cohort study. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1906-1915.e3. doi: 10.1016/j.jtcvs.2018.05.076. Epub 2018 Jun 5.
citation: Zhang X, Tan SS, Fierloos I, Zanutto O, Alhambra-Borras T, Vasiljev V, Bennett S, Rentoumis T, Buranello A, Macchione S, Rouwet E, van Grieken A, Raat H. Evaluation design of the Social Engagement Framework for Addressing the Chronic-disease-challenge (SEFAC): a mindfulness-based intervention to promote the self-management of chronic conditions and a healthy lifestyle. BMC Public Health. 2019 May 30;19(1):664. doi: 10.1186/s12889-019-6979-7.
citation: Bosco E, Hsueh L, McConeghy KW, Gravenstein S, Saade E. Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol. 2021 Nov 6;21(1):241. doi: 10.1186/s12874-021-01440-5.
citation: Monitoring and Reporting of Safety in Clinical Trials Involving Therapeutic Products and Other Clinical Research Guideline. (2019). Royal Melbourne Hospital: Office for Research.
citation: Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
citation: Lalmas, M., O'Brien, H., & Yom-Tov, E. (2015). Measuring User Engagement. Springer International Publishing
citation: Junker M, Dunnebeil S, Bohm M, Krcmar H. Usage of a workplace health promotion app: an evaluation of app usage data and medical check-up results. Health Informatics J. 2023 Jan-Mar;29(1):14604582221148058. doi: 10.1177/14604582221148058.
citation: Bauer AM, Iles-Shih M, Ghomi RH, Rue T, Grover T, Kincler N, Miller M, Katon WJ. Acceptability of mHealth augmentation of Collaborative Care: A mixed methods pilot study. Gen Hosp Psychiatry. 2018 Mar-Apr;51:22-29. doi: 10.1016/j.genhosppsych.2017.11.010. Epub 2017 Nov 24.
citation: St-Jules DE, Woolf K, Goldfarb DS, Pompeii ML, Li H, Wang C, Mattoo A, Marcum ZA, Sevick MA. Feasibility and Acceptability of mHealth Interventions for Managing Hyperphosphatemia in Patients Undergoing Hemodialysis. J Ren Nutr. 2021 Jul;31(4):403-410. doi: 10.1053/j.jrn.2020.07.009. Epub 2020 Nov 5.
citation: Hajesmaeel-Gohari S, Khordastan F, Fatehi F, Samzadeh H, Bahaadinbeigy K. The most used questionnaires for evaluating satisfaction, usability, acceptance, and quality outcomes of mobile health. BMC Med Inform Decis Mak. 2022 Jan 27;22(1):22. doi: 10.1186/s12911-022-01764-2.
citation: Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
citation: Xue P, Bai AY, Jiang Y, Qiao YL. [WHO global strategy on digital health and its implications to China]. Zhonghua Yu Fang Yi Xue Za Zhi. 2022 Feb 6;56(2):218-221. doi: 10.3760/cma.j.cn112150-20210616-00589. Chinese.
citation: Rivers JT, Smith C, Smith I, Cameron J. The Impact of a Mobile App on Participation in Cardiac Rehabilitation and Understanding Barriers to Success: Comparative Cohort Study. JMIR Cardio. 2022 Jan 17;6(1):e24174. doi: 10.2196/24174.
citation: Waterland JL, Chahal R, Ismail H, Sinton C, Riedel B, Francis JJ, Denehy L. Implementing a telehealth prehabilitation education session for patients preparing for major cancer surgery. BMC Health Serv Res. 2021 May 10;21(1):443. doi: 10.1186/s12913-021-06437-w.
citation: Hughes M, Coolsen MM, Aahlin EK, Harrison EM, McNally SJ, Dejong CH, Lassen K, Wigmore SJ. Attitudes of patients and care providers to enhanced recovery after surgery programs after major abdominal surgery. J Surg Res. 2015 Jan;193(1):102-10. doi: 10.1016/j.jss.2014.06.032. Epub 2014 Jun 23.
citation: Reeve, J., Anderson, L., Raslan, Y., Greeve, C., Ford, J., & Wilson, L. (2019). physiotherapy management of patients undergoing abdominal surgery: A survey of current practice. New Zealand Journal of Physiotherapy, 47(2).
citation: Patman S, Bartley A, Ferraz A, Bunting C. Physiotherapy in upper abdominal surgery - what is current practice in Australia? Arch Physiother. 2017 Aug 15;7:11. doi: 10.1186/s40945-017-0039-3. eCollection 2017.
citation: Samnani SS, Umer MF, Mehdi SH, Farid FN. Impact of Preoperative Counselling on Early Postoperative Mobilization and Its Role in Smooth Recovery. Int Sch Res Notices. 2014 Oct 28;2014:250536. doi: 10.1155/2014/250536. eCollection 2014.
citation: Fagevik Olsen M, Wennberg E, Johnsson E, Josefson K, Lonroth H, Lundell L. Randomized clinical study of the prevention of pulmonary complications after thoracoabdominal resection by two different breathing techniques. Br J Surg. 2002 Oct;89(10):1228-34. doi: 10.1046/j.1365-2168.2002.02207.x.
citation: Boden I, Robertson IK, Neil A, Reeve J, Palmer AJ, Skinner EH, Browning L, Anderson L, Hill C, Story D, Denehy L. Preoperative physiotherapy is cost-effective for preventing pulmonary complications after major abdominal surgery: a health economic analysis of a multicentre randomised trial. J Physiother. 2020 Jul;66(3):180-187. doi: 10.1016/j.jphys.2020.06.005. Epub 2020 Jul 14.
citation: Boden I, El-Ansary D, Zalucki N, Robertson IK, Browning L, Skinner EH, Denehy L. Physiotherapy education and training prior to upper abdominal surgery is memorable and has high treatment fidelity: a nested mixed-methods randomised-controlled study. Physiotherapy. 2018 Jun;104(2):194-202. doi: 10.1016/j.physio.2017.08.008. Epub 2017 Sep 1.
citation: Rodriguez-Aldrete D, Candiotti KA, Janakiraman R, Rodriguez-Blanco YF. Trends and New Evidence in the Management of Acute and Chronic Post-Thoracotomy Pain-An Overview of the Literature from 2005 to 2015. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):762-72. doi: 10.1053/j.jvca.2015.07.029. Epub 2015 Jul 29. No abstract available.
citation: Kendall F, Oliveira J, Peleteiro B, Pinho P, Bastos PT. Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disabil Rehabil. 2018 Apr;40(8):864-882. doi: 10.1080/09638288.2016.1277396. Epub 2017 Jan 17.
citation: Wang YQ, Liu X, Jia Y, Xie J. Impact of breathing exercises in subjects with lung cancer undergoing surgical resection: A systematic review and meta-analysis. J Clin Nurs. 2019 Mar;28(5-6):717-732. doi: 10.1111/jocn.14696. Epub 2018 Nov 20.
citation: Shahood H, Pakai A, Kiss R, Eva B, Szilagyi N, Sandor A, Verzar Z. Effectiveness of Preoperative Chest Physiotherapy in Patients Undergoing Elective Cardiac Surgery, a Systematic Review and Meta-Analysis. Medicina (Kaunas). 2022 Jul 8;58(7):911. doi: 10.3390/medicina58070911.
citation: Xu X, Cheung DST, Smith R, Lai AYK, Lin CC. The effectiveness of pre- and post-operative rehabilitation for lung cancer: A systematic review and meta-analysis on postoperative pulmonary complications and length of hospital stay. Clin Rehabil. 2022 Feb;36(2):172-189. doi: 10.1177/02692155211043267. Epub 2021 Sep 8.
citation: Clode NJ, Perry MA, Wulff L. Does physiotherapy prehabilitation improve pre-surgical outcomes and influence patient expectations prior to knee and hip joint arthroplasty? Int J Orthop Trauma Nurs. 2018 Aug;30:14-19. doi: 10.1016/j.ijotn.2018.05.004. Epub 2018 Jun 25.
citation: Jahic D, Omerovic D, Tanovic AT, Dzankovic F, Campara MT. The Effect of Prehabilitation on Postoperative Outcome in Patients Following Primary Total Knee Arthroplasty. Med Arch. 2018 Dec;72(6):439-443. doi: 10.5455/medarh.2018.72.439-443.
citation: Assouline B, Cools E, Schorer R, Kayser B, Elia N, Licker M. Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Ann Am Thorac Soc. 2021 Apr;18(4):678-688. doi: 10.1513/AnnalsATS.202002-183OC.
citation: Marquina C, Talic S, Vargas-Torres S, Petrova M, Abushanab D, Owen A, Lybrand S, Thomson D, Liew D, Zomer E, Ademi Z. Future burden of cardiovascular disease in Australia: impact on health and economic outcomes between 2020 and 2029. Eur J Prev Cardiol. 2022 May 27;29(8):1212-1219. doi: 10.1093/eurjpc/zwab001.