From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery

NCT07716761 | Not Yet Recruiting

• 1 other identifier: Prehab2Rehab_CardiacSurgery
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Prehab2Rehab is a prospective single-arm feasibility study evaluating the implementation of a multimodal, digitally supported prehabilitation program for adults awaiting elective cardiac surgery. During the routine preoperative waiting period, participants receive individualized education, psychosocial support, nutritional counselling, home-based physical activity guidance, and digital self-management support. The study aims to determine the feasibility, acceptability, usability, and safety of integrating this multidisciplinary prehabilitation pathway into routine clinical care. Exploratory outcomes include functional capacity, psychological well-being, nutritional status, digital engagement, and selected perioperative clinical outcomes to inform the design of future confirmatory trials.

Conditions

Heart Valve Surgery; Coronary Artery Bypass Grafting (CABG) Surgery; Surgical Closure of an Atrial Septal Defect (ASD)

Keywords

prehabilitation; cardiac surgery; outcomes research

Outcome Measures

Primary Outcomes (6)

• Proportion of eligible patients providing written informed consent (Recruitment rate)

  Proportion of eligible patients who provide written informed consent and are enrolled in the study.

  From study initiation until completion of recruitment (approximately 6 months)

• Proportion of enrolled participants completing the study (Participant retention)

  Proportion of enrolled participants who complete the prehabilitation program and scheduled study assessments through follow-up.

  From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)

• Proportion of completed intervention components (Adherence to the prehabilitation program)

  Participant adherence to the planned intervention components, including educational sessions, psychosocial support, nutritional counselling, home-based physical activity guidance, and use of digital support tools, assessed using attendance records and digital activity logs.

  Throughout the preoperative intervention period (approximately 6-10 weeks)

• Proportion of completed study assessments and available study data (Data completeness)

  Proportion of planned study assessments, questionnaires, and clinical data successfully completed at each scheduled assessment time point.

  From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)

• Participant-reported usability and acceptability scores for the digital support tools

  Participant-reported usability and acceptability of the digital applications used during the prehabilitation program, assessed using a study-specific evaluation questionnaire and digital usage metrics.

  At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)

• Number, severity, and type of intervention-related adverse events

  Number, severity, and type of intervention-related adverse events occurring during participation in the prehabilitation program.

  From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)

Study Arms (1)

Digitally Supported Prehabilitation

EXPERIMENTAL

Participants receive a personalized, multimodal, digitally supported prehabilitation program during the routine preoperative waiting period before elective cardiac surgery. The program includes patient education, psychosocial support, nutritional counselling, individualized home-based physical activity guidance, and digital self-management support in addition to routine clinical care.

Other: Digitally supported prehabilitation program

Interventions

Digitally supported prehabilitation program OTHER

The Prehab2Rehab intervention is a personalized, multimodal, digitally supported prehabilitation program delivered during the routine 6-10 week preoperative waiting period before elective cardiac surgery. The program includes structured patient education, psychosocial support, nutritional assessment and counselling, individualized home-based physical activity guidance (including aerobic exercise, resistance training, breathing exercises, and inspiratory muscle training), and digital tools to support education, communication, self-management, and documentation. The intervention is delivered by a multidisciplinary team and complements routine perioperative care without altering standard clinical management.

Digitally Supported Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years
• Classification as New York Heart Association (NYHA) functional class I-II
• Low surgical risk profile, defined as a EuroSCORE between 0 and 3
• Scheduled for one of the following elective cardiac surgical procedures:
• Open-heart valve surgery
• Coronary artery bypass grafting (CABG)
• Combined valve surgery and CABG
• Surgical closure of an atrial septal defect (ASD)
• Primary residence in Vienna to ensure the feasibility of in-person assessments and supervised sessions
• Sufficient German language proficiency to participate in assessments and educational components
• Adequate digital literacy to engage with the digital support tools used in the intervention
• Clinical and physical assessment confirming that participation in exercise training is medically safe

You may not qualify if:

• Emergency, urgent, or otherwise non-elective cardiac surgery
• Highly complex or specialized surgical procedures (e.g., aortic aneurysm repair, cardiac tumor resections)
• Interventional cardiac procedures (e.g., transcatheter aortic valve implantation \[TAVI\], MitraClip interventions)
• Neuromotor or physical impairments that might prevent adherence to the study protocol or informed participation
• Contraindications to spiroergometry according to current guidelines:
• Absolute contraindications:
• Acute coronary syndrome
• Symptomatic cardiac arrhythmias and/or hemodynamic instability
• Decompensated heart failure
• Acute pulmonary embolism
• Acute endocarditis, myocarditis, or pericarditis
• Febrile infections
• Acute deep vein thrombosis of the lower extremities
• Relative contraindications:
• Left main coronary artery stenosis

Sponsors & Collaborators

• Ludwig Boltzmann Institute for Digital Health and Prevention: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location

Central Study Contacts

Tanja A Stamm, Univ. Prof. Dr.

CONTACT

+43 1 40400 16370; tanja.stamm@meduniwien.ac.at

Valentin Ritschl, PhD

CONTACT

+43 1 40400 16300; valentin.ritschl@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm feasibility trial

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)