From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery (Prehab2Rehab)
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background
Patients awaiting elective cardiac surgery frequently experience reduced physical capacity, psychological distress, and modifiable lifestyle-related risk factors that may negatively influence perioperative recovery. While advances in cardiac surgery have substantially improved survival, optimizing patients' physical and psychological condition before surgery has become an increasingly important component of perioperative care.
Multimodal prehabilitation has shown promising results in several surgical populations by combining exercise, nutritional support, psychological interventions, and patient education. However, structured prehabilitation programs are not routinely implemented in Austria because of organizational, logistical, and resource-related barriers. Digital health technologies provide an opportunity to integrate multidisciplinary prehabilitation into existing clinical pathways while minimizing disruption to routine care.
The Prehab2Rehab project was developed to establish an integrated, digitally supported care pathway that connects the preoperative waiting period with postoperative rehabilitation. Rather than replacing routine care, the intervention complements existing clinical services by providing structured support before surgery and facilitating patient engagement throughout the perioperative pathway.
Study Design
This prospective, single-arm observational feasibility study will be conducted at the Vienna General Hospital (Medical University of Vienna). Approximately 40 adults scheduled for elective low-risk cardiac surgery (NYHA class I-II) will participate in a multimodal prehabilitation program delivered during the routine preoperative waiting period of approximately 6-10 weeks.
The primary objective is to evaluate the feasibility of implementing the intervention in routine clinical practice. Feasibility outcomes include recruitment and retention, adherence to intervention components, completeness of data collection, usability and acceptability of the digital support tools, and intervention safety.
Secondary exploratory analyses will estimate within-group changes in functional performance, psychological well-being, nutritional status, health-related quality of life, and selected perioperative clinical outcomes. These data will be used to estimate effect sizes and inform the design of future randomized controlled trials.
Intervention
The Prehab2Rehab intervention is a personalized, multimodal prehabilitation program integrated into routine perioperative care. It includes:
structured patient education regarding surgery, recovery, and self-management, psychosocial support focusing on stress management, coping strategies, motivation, and self-efficacy, nutritional assessment and individualized nutritional counselling, individualized home-based physical activity guidance, including aerobic exercise, resistance exercises, breathing exercises, and inspiratory muscle training, digital support for education, communication, activity documentation, and care coordination through study-specific digital platforms.
The intervention is individualized according to participants' clinical status and preferences and is delivered by a multidisciplinary team including physicians, psychologists, dietitians, physiotherapists/sports scientists, and study staff. Participation in the study does not alter routine surgical management or postoperative rehabilitation.
Assessments
Participants are assessed at baseline before prehabilitation, immediately before surgery, and after completion of structured Phase II cardiac rehabilitation. Assessments include measures of functional capacity, nutritional status, patient-reported outcomes, digital engagement, intervention adherence, safety, and routinely collected perioperative clinical outcomes. In addition, semi-structured qualitative interviews with patients and healthcare professionals will explore acceptability, user experiences, implementation barriers, and facilitators to support future implementation in routine clinical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tanja A Stamm, Univ. Prof. Dr.
- Phone Number: +43 1 40400 16370
- Email: tanja.stamm@meduniwien.ac.at
Study Contact Backup
- Name: Valentin Ritschl, PhD
- Phone Number: +43 1 40400 16300
- Email: valentin.ritschl@meduniwien.ac.at
Study Locations
-
-
State of Vienna
-
Vienna, State of Vienna, Austria, 1090
- Medical University of Vienna
-
Contact:
- Valentin Ritschl, PhD
- Phone Number: +43 1 40400 16300
- Email: valentin.ritschl@meduniwien.ac.at
-
Contact:
- Valentina Schmolik, MSc
- Phone Number: +43 1 40400 16330
- Email: valentina.schmolik@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Electrolyte imbalances
- Arterial hypertension (>160 mmHg systolic)
- Tachyarrhythmias
- Hypertrophic obstructive cardiomyopathy (HOCM)
- High-grade atrioventricular block
- Anemia
- Physical or psychological impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digitally Supported Prehabilitation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of eligible patients providing written informed consent (Recruitment rate)
Time Frame: From study initiation until completion of recruitment (approximately 6 months)
|
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)
Time Frame: From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
|
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)
Time Frame: Throughout the preoperative intervention period (approximately 6-10 weeks)
|
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)
Time Frame: From baseline until completion of follow-up after Phase II cardiac rehabilitation (approximately 4-6 months)
|
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
Time Frame: At the preoperative assessment following completion of the prehabilitation program (approximately 6-10 weeks after baseline)
|
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
Time Frame: From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)
|
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)
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Prehab2Rehab_CardiacSurgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.