Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Location contact
Valentin Ritschl, PhD
CONTACT
Valentina Schmolik, MSc
CONTACT
NCT Number: NCT07716761
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Vienna, State of Vienna, 1090, Austria
Valentin Ritschl, PhD
CONTACT
Valentina Schmolik, MSc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Absolute contraindications:
Relative contraindications:
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Tanja A Stamm, Univ. Prof. Dr.
CONTACT
Valentin Ritschl, PhD
CONTACT
Ludwig Boltzmann Institute for Digital Health and Prevention
Other
From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
Acronym: Prehab2Rehab
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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