From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
Major visceral oncologic surgery is associated with high postoperative morbidity, prolonged hospitalization, delayed recovery, and reduced quality of life. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical fitness, malnutrition, sarcopenia, and psychological distress, all of which may negatively affect surgical outcomes and rehabilitation. Although prehabilitation has shown potential to improve functional capacity before surgery, structured prehabilitation pathways are currently not routinely implemented in Austria, and the feasibility of digitally supported perioperative care pathways remains insufficiently evaluated.
The aim of the Prehab2Rehab-OncoVis study is to evaluate the feasibility, acceptability, and safety of a multimodal, digitally supported prehabilitation intervention for patients undergoing major visceral oncologic surgery with curative intent. The study will additionally explore potential effects on clinical recovery, functional capacity, rehabilitation outcomes, and patient-reported outcomes across the perioperative pathway.
Prehab2Rehab-OncoVis is designed as a prospective, single-arm feasibility cohort study conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation, coordinated by the Paracelsus Medical University in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the Prehab2Rehab consortium. Approximately 30 adult patients, with the possibility to include up to 50 participants if feasible, will be consecutively recruited.
The intervention consists of a four-week multimodal prehabilitation program combining supervised exercise training, promotion of physical activity, nutritional counseling, psycho-oncological distress screening, and health literacy support. Digital tools will support the intervention throughout the perioperative pathway, including the HERO application (Das Herz Reha-Informationstool) for patient education and health literacy, aktivplan as a digital exercise planner and training diary, and the CAATS telecommunication platform for remote supervision and tele-prehabilitation sessions where appropriate.
The exercise intervention includes supervised center-based sessions and, for participants with longer travel distances, a hybrid model combining center-based and tele-prehabilitation sessions. Nutritional counseling will follow current European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines and includes screening for malnutrition risk. Psycho-oncological distress screening will follow recommendations of the German Cancer Society and includes referral to supportive care when clinically indicated.
Participants will be assessed throughout the perioperative pathway, including at the beginning and end of prehabilitation (Prehabilitation Assessment 1 [PRE1] and Prehabilitation Assessment 2 [PRE2]), during hospitalization and rehabilitation, and at a three-month follow-up after surgery. Primary outcomes focus on feasibility, including recruitment and retention rates, adherence, fidelity, safety, data management feasibility, and acceptability and usability of the digital technologies. Secondary outcomes include clinical recovery indicators, postoperative complications, length of hospital and intensive care stay, functional independence, psychological well-being, quality of life, body composition, cardiorespiratory fitness, functional exercise capacity, and muscle strength.
To contextualize outcomes, two historical comparator cohorts will be used: a local hospital cohort of patients who previously underwent similar surgery without prehabilitation, and a national rehabilitation cohort derived from routine rehabilitation datasets matched for diagnosis, sex, and age.
The study is intended to generate feasibility data and preliminary estimates that may support the development of future adequately powered randomized controlled trials evaluating digitally supported prehabilitation and rehabilitation pathways in visceral oncologic surgery.
详细描述
Major visceral oncologic surgery remains one of the most physiologically demanding therapeutic interventions in modern cancer care. Patients undergoing surgery of the pancreas, liver, bile ducts, stomach, or esophagus frequently present with reduced physical reserve, impaired nutritional status, sarcopenia, cancer-related fatigue, reduced exercise tolerance, psychological distress, and multiple comorbidities. These factors contribute substantially to postoperative morbidity, prolonged recovery, delayed rehabilitation, reduced quality of life, and increased health care utilization.
Despite advances in surgical and perioperative care, postoperative complications remain common after major visceral oncologic surgery. Functional decline following surgery may additionally impair the initiation or completion of adjuvant oncologic therapies, potentially affecting long-term prognosis. Therefore, strategies that optimize patients before surgery and support continuity of recovery throughout the perioperative pathway are increasingly recognized as clinically relevant.
Prehabilitation aims to improve the physiological and psychological readiness of patients before surgery through targeted interventions, commonly including exercise training, nutritional optimisation, psychological support, and health education. Previous studies have shown that prehabilitation may improve functional capacity and may contribute to improved postoperative recovery. However, important gaps remain regarding implementation feasibility, integration into routine clinical care, long-term continuity between prehabilitation and rehabilitation, and the role of digital technologies in supporting patient engagement and adherence.
In Austria, structured prehabilitation pathways are currently not routinely implemented for patients undergoing major visceral oncologic surgery. Furthermore, perioperative care pathways often remain fragmented, particularly during the transition from surgical hospitalization to rehabilitation. Digital technologies have the potential to improve continuity of care, facilitate communication, support self-management, and improve adherence to exercise and rehabilitation programs. Nevertheless, the feasibility and acceptance of digitally supported perioperative pathways in this patient population remain insufficiently investigated.
The Prehab2Rehab-OncoVis study was therefore developed to evaluate the feasibility, safety, acceptability, and implementation characteristics of a multimodal digitally supported prehabilitation pathway extending from preoperative preparation through rehabilitation and follow-up. The study additionally aims to generate preliminary clinical and functional outcome data that may support the planning of future randomized controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults aged 18 years or older
- •Clinical diagnosis requiring major surgery of the pancreas, liver, bile ducts, stomach, or esophagus with curative intent
- •Confirmed indication for surgery by the multidisciplinary tumor board
- •Medical stability and physician clearance to participate in a prehabilitation exercise program
- •Willingness and ability to attend center-based prehabilitation exercise sessions three times per week, or once per week with additional tele-prehabilitation if travel time exceeds 40 minutes one way
- •Willingness and ability to perform home-based physical activities
- •Sufficient German language proficiency and digital literacy
- •Access to a smartphone or tablet device with internet connection
- •Provision of written informed consent
排除标准
- •Age younger than 18 years
- •Physical disability or mental impairment preventing safe participation in the study
- •Health care medical power of attorney not permitting independent consent
- •Non-elective, emergency, or revision surgery
- •Acute medical condition contraindicating participation in a structured prehabilitation program
