From Prehabilitation to Rehabilitation (Prehab2Rehab): Digitally Supported Short-Term Prehabilitation Prior to Cardiac Surgery - A Prospective Observational Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •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
- •Physical or psychological impairments
研究组 & 干预措施
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.
干预措施: Digitally supported prehabilitation program (Other)
结局指标
主要结局
Recruitment rate
时间窗: 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.
Participant retention
时间窗: 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.
Adherence to the prehabilitation program
时间窗: 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.
Completeness of study data collection
时间窗: 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.
Usability and acceptability of the digital support tools
时间窗: 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.
Safety of the prehabilitation intervention
时间窗: 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.
Proportion of eligible patients providing written informed consent (Recruitment rate)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点