The PREBEAT Trial: Digital PREhaBilitation in thE Cardiac Surgical populATion

Claire Hines

Status: Not yet enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: Digital Cardiac Prehabilitation; Other: Control (Standard treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06983808

RMIT-HREC 28861

RMH-HREC 2024.163 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Other: Control (Standard treatment)

Digital Health Arm

Experimental group

Description:

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

Treatment:

Other: Digital Cardiac Prehabilitation