Coronary Artery Bypass Grafting (CABG) SurgeryPrehab2RehabNCT07716761
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery
A study testing Digitally supported prehabilitation program in people with Coronary Artery Bypass Grafting (CABG) Surgery and Heart Valve Surgery, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery, Surgical Closure of an Atrial Septal Defect (ASD)
- What is being tested?
- Digitally supported prehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2026to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Vienna
Vienna, State of Vienna, 1090
Valentin Ritschl, PhD, +43 1 40400 16300, valentin.ritschl@meduniwien.ac.at
Valentina Schmolik, MSc, +43 1 40400 16330, valentina.schmolik@meduniwien.ac.at
About this study
Official title: From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
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.
Read the 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.
- Conditions
- Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery, Surgical Closure of an Atrial Septal Defect (ASD)
- Being tested
- Digitally supported prehabilitation program
- Keywords
- prehabilitation, cardiac surgery, outcomes research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally supported prehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digitally supported prehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Grafting (CABG) SurgeryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm feasibility trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716761
- Sponsor's protocol ID
- Prehab2Rehab_CardiacSurgery
- Acronym
- Prehab2Rehab
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because of privacy and data protection regulations (GDPR) and the small sample size, which may increase the risk of participant identification. Aggregated study results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
- ClinicalTrials.gov ID
- NCT07716761
- Acronym / sponsor ID
- Prehab2Rehab / Prehab2Rehab_CardiacSurgery
- Conditions
- Coronary Artery Bypass Grafting (CABG) Surgery, Heart Valve Surgery, Surgical Closure of an Atrial Septal Defect (ASD)
- Keywords
- prehabilitation, cardiac surgery, outcomes research
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Digital Health and PreventionUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Jul 2026 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Digitally Supported Prehabilitation | Experimental | Other: Digitally supported prehabilitation programParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Primary residence in Vienna to ensure the feasibility of in-person assessments and supervised sessions
Key exclusion criteria (22 listed)
- 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:
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 |
|---|---|---|
| Digitally supported prehabilitation programThe 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. | Other | Digitally Supported Prehabilitation |
Primary outcome
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.
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.
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.
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.
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.
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.
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 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because of privacy and data protection regulations (GDPR) and the small sample size, which may increase the risk of participant identification. Aggregated study results will be reported in scientific publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally supported prehabilitation program in people with Coronary Artery Bypass Grafting (CABG) Surgery and Heart Valve Surgery, run by Ludwig Boltzmann Institute for Digital Health and Prevention at 1 site in Austria.
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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 24 Jul 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 Austria. 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 Tanja A Stamm, Univ. Prof. Dr. (+43 1 40400 16370, tanja.stamm@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients providing written informed consent (Recruitment rate) (time frame: From study initiation until completion of recruitment (approximately 6 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.