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

Официальное название

From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Digitally supported prehabilitation program
  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 sup

Первичные конечные точки

• Proportion of eligible patients providing written informed consent (Recruitment rate) [Срок оценки: From study initiation until completion of recruitment (approximately 6 months)]
• Proportion of enrolled participants completing the study (Participant retention) [Срок оценки: 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) [Срок оценки: Throughout the preoperative intervention period (approximately 6-10 weeks)]
• Proportion of completed study assessments and available study data (Data completeness) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrolment until completion of the prehabilitation program (approximately 6-10 weeks)]

Критерии участия

Критерии включения

\- 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Австрия · 1 центр

• Medical University of Vienna — Vienna

Идентификаторы

NCT: NCT07716761 · Prehab2Rehab_CardiacSurgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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