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| ID | Type | Description | Link |
|---|---|---|---|
| EK 1182/2025 | Other Identifier | Ethics Committee of the State of Salzburg |
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| Name | Class |
|---|---|
| Salzburger Landeskliniken | OTHER |
| Paracelsus Medical University | OTHER |
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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.
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.
The study is conducted at the University Hospital Salzburg and the University Institute of Sports Medicine, Prevention and Rehabilitation in cooperation with the Ludwig Boltzmann Institute for Rehabilitation Research and the Ludwig Boltzmann Institute for Digital Health and Prevention within the framework of the Prehab2Rehab consortium.
The study is designed as a prospective single-arm feasibility cohort study. Approximately 30 adult patients scheduled for major visceral oncologic surgery with curative intent will be consecutively recruited, with the possibility of including up to 50 participants if feasible within the recruitment period. Historical comparison cohorts will additionally be used to contextualize observed outcomes. These include 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 primary objective of the study is to evaluate feasibility outcomes associated with the implementation of the digitally supported multimodal prehabilitation intervention. Feasibility outcomes include recruitment rate, retention rate, communication with participants, data collection and data management performance, adherence to the intervention, intervention fidelity, safety, and acceptability of the digital technologies.
Recruitment feasibility will be evaluated by documenting the proportion of eligible patients who provide written informed consent for study participation. Retention feasibility will be assessed by determining the proportion of enrolled participants who complete the intervention and study assessments. Intervention adherence will be assessed through attendance at supervised sessions, completion of prescribed activities, and use of the digital tools. Fidelity will evaluate the degree to which the intervention is implemented according to the planned protocol and standardized procedures.
Acceptability and usability of the digital tools will be evaluated using validated questionnaires, including the Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2), the mHealth App Usability Questionnaire (MAUQ), the Mobile Application Rating Scale (MARS), AttrakDiff, and the Affinity for Technology Interaction (ATI) questionnaire. In addition, qualitative participant experiences will be explored through semi-structured interviews performed after completion of the intervention pathway.
The intervention consists of a multimodal prehabilitation program combining supervised exercise training, nutritional counseling, psycho-oncological distress screening, promotion of health literacy, and digitally supported patient engagement. The exercise intervention follows a structured multimodal approach and is individualized according to medical evaluation, baseline functional capacity, and therapist judgment. The intervention is delivered in two formats depending on travel distance and feasibility.
Participants living within practical traveling distance of the training center participate in a standard center-based exercise program consisting of three supervised exercise sessions per week at the University Institute of Sports Medicine, Prevention and Rehabilitation. Participants with travel times exceeding approximately 40 minutes one way may participate in a hybrid model consisting of one supervised center-based session and two remotely supervised tele-prehabilitation sessions per week.
Exercise sessions are structured according to the Frequency, Intensity, Time, and Type (FITT) principles and include warm-up, endurance training, resistance training, and cool-down phases. Endurance exercise is primarily performed on stationary cycle ergometers at moderate intensity. Resistance exercise includes machine-based or elastic-band-based exercises targeting major muscle groups. Exercise intensity and progression are adapted individually according to baseline assessment, perceived exertion, and clinical status. During supervised endurance exercise sessions, patient safety is ensured through clinical supervision by exercise therapists and physicians. Electrocardiographic monitoring may be used when clinically indicated. Emergency procedures and emergency equipment are available during all center-based sessions.
The hybrid tele-prehabilitation sessions are conducted using the CAATS telecommunication platform. During remote sessions, participants receive live visual supervision from the therapist. If adequate visual supervision cannot be established, the tele-prehabilitation session is not conducted. The tele-prehabilitation format was developed to improve feasibility and accessibility for participants living farther away from the training center while maintaining structured supervision and continuity.
Participants are additionally encouraged to maintain an active lifestyle outside supervised sessions. Home-based physical activity recommendations include regular walking and low-to-moderate intensity activities integrated into daily life. Physical activity guidance is progressively adapted across the intervention period.
Nutritional counseling is performed in parallel with the exercise intervention and follows current European Society for Clinical Nutrition and Metabolism (ESPEN) recommendations for clinical nutrition in surgery. Nutritional screening includes assessment using the Nutritional Risk Screening 2002 score (NRS-2002). Individualized counseling aims to optimize preoperative nutritional status and ensure adequate caloric and protein intake. When clinically indicated, oral nutritional supplementation may be recommended. Nutritional counseling is primarily delivered through face-to-face consultations but may additionally be supported through teleconsultation using the CAATS platform.
Psycho-oncological distress screening is integrated into the intervention pathway in accordance with recommendations of the German Cancer Society and psycho-oncological guidelines. Screening includes use of the National Comprehensive Cancer Network (NCCN) Distress Thermometer and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants exceeding predefined thresholds or requesting support may be referred for psycho-oncological counseling and supportive care according to standard clinical pathways.
Health literacy promotion represents an additional core component of the intervention. Health literacy is evaluated using the European Health Literacy Questionnaire (HLS-EU-Q) and the Brief Health Literacy Screening Tool (BRIEF). Educational support is provided using the HERO application. The HERO application was developed to provide structured evidence-based information throughout the perioperative pathway. The application includes educational material regarding disease-related information, surgery, rehabilitation, physical activity, recovery processes, and patient orientation. The HERO application serves exclusively as an educational and motivational support tool and is not intended as a diagnostic or therapeutic medical device.
The aktivplan application is used as a digital exercise planner and training diary. It allows participants to access prescribed exercise sessions, document completed activities, receive reminders, and maintain an overview of their training schedule. The application additionally supports adherence monitoring and allows the study team to evaluate engagement and implementation fidelity. Together, HERO, aktivplan, and CAATS form an integrated digital support environment intended to facilitate continuity between prehabilitation, surgery, transition, rehabilitation, and recovery.
The perioperative pathway assessed within the study includes multiple predefined phases and assessment time points. Baseline assessments are performed at the start of prehabilitation (Prehabilitation Assessment 1 [PRE1]). Repeat assessments are conducted after completion of the prehabilitation intervention but before surgery (Prehabilitation Assessment 2 [PRE2]). Surgical hospitalization and postoperative recovery are subsequently documented. Rehabilitation-related assessments are performed at admission to rehabilitation (Rehabilitation Assessment 1 [REH1]) and at discharge from rehabilitation (Rehabilitation Assessment 2 [REH2]). A final follow-up assessment is conducted approximately three months after surgery.
The rehabilitation phase itself is conducted as usual care without modification of standard rehabilitation procedures. However, participants who undergo rehabilitation at the affiliated rehabilitation center are systematically followed to evaluate rehabilitation outcomes and user experiences across the complete treatment pathway.
Secondary outcomes are exploratory and intended to provide preliminary information regarding potential effects of the intervention on clinical, functional, physiological, and patient-reported outcomes. Clinical recovery indicators include time to functional recovery, postoperative complications, Comprehensive Complication Index, length of intensive care unit stay, length of hospital stay, readmission rates, and short-term mortality. Postoperative complications are documented according to the Clavien-Dindo classification. Functional independence and activity-related outcomes include the Barthel Index, Eastern Cooperative Oncology Group Performance Status, Rapid Assessment of Physical Activity, and Exercise Self-Efficacy Scale. Psychological well-being and quality of life are assessed using the Patient Health Questionnaire-4 (PHQ-4), Hospital Anxiety and Depression Scale (HADS), EuroQol-5 Dimensions-5 Levels questionnaire (EQ-5D-5L), NCCN Distress Thermometer, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Broader rehabilitation-related and vocational aspects are additionally explored using the International Classification of Functioning, Disability and Health framework and the Screening Instrument for Medical-Vocational Oriented Measures Clinical Version (SIMBO-C).
The study additionally includes exploratory assessments related to patient blood management and metabolic control. Patient blood management procedures follow current Austrian, European, and international recommendations. Routine laboratory assessments include hemoglobin concentration, ferritin, transferrin saturation, and related hematological parameters. These measurements are intended for scientific characterization and are not used for clinical treatment decisions. Metabolic assessments include fasting glucose and glycated hemoglobin (HbA1c) measurements. Participants with abnormal glucose metabolism may receive additional counseling and optimization according to routine clinical practice.
Functional and physiological assessments are additionally performed to characterize changes in physical capacity throughout the perioperative pathway. Anthropometric measurements include body mass, body height, and body mass index. Body composition is assessed using bioelectrical impedance analysis to estimate lean mass, fat mass, and phase angle. Cardiorespiratory fitness is evaluated using cardiopulmonary exercise testing performed on an electronically braked cycle ergometer. Measures include peak oxygen uptake and maximal mechanical work capacity. Continuous electrocardiographic monitoring and standardized safety procedures are used during testing. Functional exercise capacity is evaluated using the Six-Minute Walk Test and the Timed Up and Go test. Muscle strength is evaluated using standardized handgrip dynamometry procedures.
The study additionally incorporates qualitative evaluation methods. Semi-structured interviews are performed with a subset of participants to explore user experiences, perceived barriers, facilitators of participation, and perceptions regarding the digital support pathway. Interviews are audio-recorded with participant consent, transcribed, pseudonymized, and analyzed qualitatively.
All participant data are pseudonymized at the time of collection. A separate identification log linking participant identity to study identifiers is stored securely with restricted access. Data handling procedures comply with the European General Data Protection Regulation (GDPR) and institutional data protection requirements. The study is conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice (GCP). Ethical approval was obtained from the responsible ethics committee before participant recruitment. All participants provide written informed consent before participation in any study-related procedures. Safety monitoring includes systematic documentation of adverse events and serious adverse events occurring during the study period. Exercise-related safety is ensured through supervised training, standardized emergency procedures, and predefined stopping criteria. Serious adverse events related or potentially related to study procedures are reported according to institutional and regulatory requirements.
Statistical analyses primarily focus on feasibility and implementation outcomes. Descriptive statistics are used to summarize recruitment, retention, adherence, acceptability, usability, and safety data. Exploratory analyses may additionally evaluate changes in clinical and functional outcomes over time and contextual comparisons with historical cohorts. The study is not powered to provide definitive conclusions regarding intervention efficacy. The results of the study are intended to provide important feasibility and implementation data regarding the integration of digitally supported prehabilitation pathways into perioperative care for patients undergoing major visceral oncologic surgery. Findings from this study may support the design of future larger randomized controlled trials and contribute to the development of integrated perioperative care pathways connecting prehabilitation, surgery, rehabilitation, and digital health support.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digitally Supported Multimodal Prehabilitation | Experimental | Participants scheduled for major visceral oncologic surgery will undergo a four week multimodal digitally supported prehabilitation intervention before surgery. The intervention includes supervised exercise training, home based physical activity, nutritional counseling, psycho oncological distress screening, health literacy support, and perioperative optimization. Digital support will be provided through the HERO application, aktivplan, and CAATS to support education, communication, self management, and continuity of care across the perioperative pathway, including the transition from hospital discharge to inpatient rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digitally Supported Multimodal Prehabilitation | Behavioral | Multimodal digitally supported prehabilitation consisting of supervised exercise training, nutritional counseling, psycho-oncological distress screening, and health literacy support before major visceral oncologic surgery. The exercise intervention includes endurance, resistance, mobility, and breathing exercises delivered either as three supervised center-based sessions per week or as a hybrid model combining one center-based session with two tele-prehabilitation sessions weekly for patients with longer travel distances. Participants are additionally encouraged to maintain home-based physical activity. Digital support is provided through the HERO application for health literacy and patient education, aktivplan as a digital exercise planner and training diary, and the CAATS platform for tele-prehabilitation and remote consultations. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | The recruitment rate will be calculated as the percentage of eligible patients who consent to participate in the study. The reported value will be: (number of enrolled participants / number of eligible patients) × 100%. | Continuous throughout the recruitment period (12 months recruitment period) |
| Retention Rate | The retention rate will be calculated as the percentage of enrolled participants who complete the study according to the protocol. The reported value will be: (number of participants completing the study / number of enrolled participants) × 100%. | Continuous throughout the data collection period (12 months data collection period). |
| Communication with Participants | Communication with participants will be assessed by documenting the schedule and duration of communication between participants and study staff to address operational and intervention-related issues throughout the study. | Continuous throughout the study period (12 months study period). |
| Data collection and entry | Data collection and entry will be assessed by documenting the time required for data handling and the performance of the data collection and entry systems throughout the study. | Continuous throughout the data collection period (12 months data collection period). |
| Adherence to the Prehabilitation intervention | Adherence will be assessed as the average proportion of prescribed prehabilitation sessions attended by participants. The reported value will be: (number of completed sessions / number of prescribed sessions) × 100%. | Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2) | Technology acceptance will be assessed using the Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2) questionnaire. Higher scores indicate greater acceptance and intention to use the digital support technologies. | End of Rehabilitation (~ 17 weeks after Baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Löb, Priv.-Doz. Dr. med. | Contact | +43 (0)5 7255-54762 | s.loeb@salk.at | |
| Clemens C Schmutzhart, Dr.med.univ. | Contact | +43 (0)5 7255-58576 | c.schmutzhart@salk.at |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Löb, Priv.-Doz. Dr. med. | Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzburger Landeskliniken | Principal Investigator |
| Daniela Wurhofer, Dr. | Ludwig Boltzmann Institute for Digital Health and Prevention |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitationszentrum St. Veit im Pongau Betriebs-GmbH | Saint Veit Im Pongau | State of Salzburg | 5621 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37019492 | Background | Faqar-Uz-Zaman SF, Sliwinski S, Detemble C, Filmann N, Zmuc D, Mohr L, Dreilich J, Bechstein WO, Fleckenstein J, Schnitzbauer AA. Study protocol for a pilot trial analysing the usability, validity and safety of an interventional health app programme for the structured prehabilitation of patients before major surgical interventions: the PROTEGO MAXIMA trial. BMJ Open. 2023 Apr 5;13(4):e069394. doi: 10.1136/bmjopen-2022-069394. | |
| 28489682 |
| Label | URL |
|---|---|
| Description: Project website describing the Prehab2Rehab framework, including prehabilitation and rehabilitation concepts, study objectives, and institutional partners. | View source |
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Individual participant data (IPD) will not be shared in order to protect participant confidentiality and in accordance with applicable data protection regulations, including the General Data Protection Regulation (GDPR). Only aggregated and fully anonymized data will be reported in scientific publications and presentations. No individual-level data will be made publicly available. Access to underlying data may be considered upon reasonable request and subject to institutional, ethical, and legal approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2026 | Jun 5, 2026 |
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Prospective single arm feasibility cohort study with a mixed methods approach. The study follows the perioperative pathway from a 4 week prehabilitation phase through surgery, hospital stay, transition phase, and inpatient rehabilitation. Participants receive a multimodal digitally supported prehabilitation intervention including supervised exercise training, home based physical activity, nutritional counseling, psycho oncological distress screening, health literacy support, and digital support tools. Two historical comparator cohorts will be used for contextual comparison of clinical and rehabilitation outcomes.
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| Fidelity to the Intervention | Fidelity will be assessed as the proportion of intervention components delivered according to the study protocol and planned intervention procedures. The reported value will be: (number of intervention components delivered as planned / number of planned intervention components) × 100%. | Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days). |
| Number of Intervention-Related Adverse Events (Safety) | Safety will be assessed based on the number and type of serious and non-serious adverse events considered related or possibly related to the intervention or study procedures. All adverse events will be documented throughout the study. | Baseline (Onset of Prehabilitation intervention), after Prehabilitation (~28 days). |
| Acceptability | Acceptability and user experience of the digital technologies will be assessed using the Mobile Application Rating Scale (MARS), a multidimensional questionnaire evaluating engagement, functionality, aesthetics, and information quality. Scores range from 1 to 5, with higher scores indicating better perceived quality and user experience. | Continuous throughout the study period (~12 months). |
| mHealth App Usability Questionnaire (MAUQ) |
Usability of the digital support technologies will be assessed using the mHealth App Usability Questionnaire (MAUQ). Higher scores indicate greater perceived usability and user satisfaction. |
| End of Rehabilitation (~ 17 weeks after Baseline). |
| Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff) | User experience of the digital support technologies will be assessed using the Perceived Hedonic and Pragmatic Quality Questionnaire (AttrakDiff). Higher scores indicate a more positive perceived user experience. | End of Rehabilitation (~ 17 weeks after Baseline). |
| Affinity for Technology Interaction (ATI) | Affinity for Technology Interaction (ATI) will be used to assess the individual's tendency to actively engage with and use technology in daily life. Higher scores indicate greater affinity for technology interaction. | Baseline (Onset of Prehabilitation intervention). |
| Time to Functional Recovery (TtFR) | Time to Functional Recovery (TtFR) will be assessed as the number of days from surgery until recovery of predefined functional recovery criteria during the postoperative hospital stay. | Hospital stays (10 to 21 days post-surgery). |
| Length of Hospital Stay (LOHS) | Length of Hospital Stay (LOHS) will be assessed as the number of days from hospital admission for surgery until hospital discharge. | Hospital stays (10 to 21 days post-surgery). |
| Comprehensive Complication Index (CCI) | The Comprehensive Complication Index (CCI) will be used to assess the overall burden of postoperative complications based on all complications occurring during the postoperative hospital stay. | Hospital stays (10 to 21 days post-surgery). |
| Length of Intensive Care Unit Stay (LoICU) | Length of Intensive Care Unit Stay (LoICU) will be assessed as the number of days spent in the intensive care unit during postoperative hospitalization. | Hospital stays (10 to 21 days post-surgery). |
| 30-day Re-admission Rate (30dRR) | The 30-day re-admission rate (30dRR) will be assessed as the proportion of participants requiring hospital re-admission within 30 days after surgery. | Transition (~42 days post-surgery), and onset of Rehabilitation (~63 days post-surgery). |
| 30-day Mortality Rate (30dMR) | The 30-day mortality rate (30dMR) will be assessed as the proportion of participants who die within 30 days after surgery. | After surgery (~21 days), transition (~35 days), onset rehabilitation (~63 days post-surgery). |
| 90-day Mortality Rate (90dMR) | The 90-day mortality rate (90dMR) will be assessed as the proportion of participants who die within 90 days after surgery. | After surgery (~21 days), transition (~35 days), after rehabilitation (28 days), follow-up (~7 days after Rehabilitation) |
| Barthel Index (BI) | The Barthel-index (BI) will be used to assess functional independence in activities of daily living, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair climbing. Total scores range from 0 to 100, with higher scores indicating greater functional independence. | Baseline (Prehabilitation onset), onset Rehabilitation (~63 days post-surgery), and after Rehabilitation (~28 days). |
| Eastern Cooperative Oncology Group Performance Status (ECOG) | The Eastern Cooperative Oncology Group Performance Status (ECOG) will be used to assess overall performance capacity and disease-related functional impairment. Scores range from 0 to 5, where 0 indicates fully active without restriction and 5 indicates death. Higher scores indicate greater functional limitation. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) and Follow-up (~7 days after Rehabilitation) |
| Rapid Assessment of Physical Activity (RAPA) | The Rapid Assessment of Physical Activity (RAPA) questionnaire will be used to assess self-reported physical activity levels, including aerobic activity, strength, and flexibility exercise participation. Higher scores indicate greater levels of physical activity. | Baseline (Prehabilitation onset) and after Rehabilitation (~28 days). |
| Exercise Self-Efficacy Scale (ESES) | The Exercise Self-Efficacy Scale (ESES) is a validated instrument developed to measure confidence in performing regular exercise under various circumstances. It includes 10 items rated on a 4-point scale, where higher scores reflect greater perceived self-efficacy for exercise. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks), and after Rehabilitation (~28 days). |
| Patient Health Questionnaire-4 (PHQ-4) | The Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief screening instrument designed to assess symptoms of anxiety and depression, comprising the two-item Generalized Anxiety Disorder scale (GAD-2) and the two-item Patient Health Questionnaire depression scale (PHQ-2). Each item is scored from 0 ("not at all") to 3 ("nearly every day"), producing a total score from 0 to 12, with higher scores indicating greater psychological distress | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks), onset Rehabilitation (~63 days post-surgery), and after Rehabilitation (~28 days). |
| Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) will be used to provide a more detailed assessment of anxiety and depressive symptoms throughout the perioperative period. It consists of 14 items divided into two subscales, HADS-A and HADS-D, each ranging from 0 to 21. Higher scores indicate greater emotional distress. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks), onset Rehabilitation (~63 days post-surgery), and after Rehabilitation (~28 days). |
| EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized, generic measure of health-related quality of life that evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity, from "no problems" to "extreme problems," and the instrument also includes a visual analogue scale (VAS) for self-rated health. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks), onset of Rehabilitation (~63 days post-surgery) after Rehabilitation (~28 days). |
| NCCN Distress Thermometer | The NCCN Distress Thermometer will be used as a rapid screening tool to identify psychological distress and supportive care needs. It includes a visual analogue scale ranging from 0 ("no distress") to 10 ("extreme distress") and an associated problem list covering physical, emotional, practical, and spiritual concerns. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks), post-surgery (~21 days), and Follow-up (~7 days after rehabilitation). |
| European Health Literacy Questionnaire (HLS-EU-Q) | The European Health Literacy Questionnaire (HLS-EU-Q) will be used to assess health literacy, including the ability to access, understand, appraise, and apply health-related information for healthcare, disease prevention, and health promotion. The questionnaire generates a health literacy index ranging from 0 to 50, where higher scores indicate better health literacy. | Baseline (Prehabilitation onset) and after Rehabilitation (~28 days) |
| Brief Health Literacy Screening Tool (BRIEF) | The Brief Health Literacy Screening Tool (BRIEF) will be used to assess participants' perceived ability to understand and use health-related information and healthcare materials. Higher scores indicate better health literacy. | Baseline (Prehabilitation onset) and after Rehabilitation (~28 days). |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is a 30-item questionnaire assessing global health status, functional domains (physical, emotional, cognitive, role, and social), and symptom burden in patients with cancer. Scores are transformed to a 0-100 scale. For the global health status and functional scales, higher scores indicate better health-related quality of life and functioning. For the symptom scales, higher scores indicate greater symptom burden and worse health status. | Baseline (Prehabilitation onset), onset Rehabilitation (~63 days post-surgery) after Rehabilitation (~28 days), and Follow-up (~7 days after Rehabilitation) |
| Nutritional Risk Screening 2002 (NRS-2002) | The Nutritional Risk Screening 2002 (NRS-2002) will be used to assess nutritional risk and risk of malnutrition in hospitalized patients. The instrument evaluates nutritional status impairment, disease severity, and age-related risk. Total scores typically range from 0 to 7, with higher scores indicating greater nutritional risk. A score of ≥3 indicates nutritional risk and the need for nutritional intervention. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks). Follow-up (~7 days after Rehabilitation). |
| International Classification of Functioning, Disability and Health (ICF) | Broader rehabilitation needs, including psychosocial and vocational aspects relevant for participation, will be assessed within an International Classification of Functioning, Disability and Health (ICF)-based framework, in accordance with the Austrian PVA medical performance profile for inpatient rehabilitation. | Onset of Rehabilitation (~63 days post-surgery). |
| Screening Instrument for Medical-Vocational Oriented Measures - Clinical Version (SIMBO-C) | The Screening Instrument for Medical-Vocational Oriented Measures - Clinical Version (SIMBO-C) will be used to assess broader rehabilitation needs, including psychosocial and vocational aspects relevant for participation and return to work during inpatient rehabilitation. | Baseline (prior intervention), onset Rehabilitation (~63 days post-surgery), after rehabilitation (28 days) |
| Glycated Hemoglobin (HbA1c) | The glycated hemoglobin HbA1c (%) will be assessed to evaluate glycemic status during the perioperative period. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks). |
| Fasting Blood Glucose | The Fasting blood glucose (mg/dl) will be assessed to evaluate the metabolic regulation during the preoperative period. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks). |
| Body Fat Mass | Body fat mass measured using bioelectrical impedance analysis (BIA). Body fat mass represents the total amount of body fat and will be reported in kilograms (kg). | Baseline (onset ), after Prehabilitation intervention (,~4 weeks), post-surgery (Discharge, ~21 days), and Follow-up (~7 days after rehabilitation completion). |
| Body mass | Body mass will be measured using a calibrated digital scale and reported in kilograms (kg). | Baseline (prior intervention), after Prehabilitation (~4 weeks), post-surgery (Discharge, ~21 days), after Rehabilitation (~ 28 days) and Follow-up (~7 days after rehabilitation). |
| Body Height | Body height will be measured using a stadiometer and reported in centimeters (cm). | Baseline (prior intervention), after Prehabilitation (~4 weeks), post-surgery (Discharge, ~21 days), after Rehabilitation (~ 28 days) and Follow-up (~7 days after rehabilitation). |
| Body mass Index (BMI) | Body mass index (BMI) will be calculated as body mass in kilograms divided by height in meters squared and reported in kilograms per square meter (kg/m²). | Baseline (prior intervention), after Prehabilitation (~4 weeks), post-surgery (Discharge, ~21 days), after Rehabilitation (~ 28 days) and Follow-up (~7 days after rehabilitation). |
| Body Lean Mass | Body Lean Mass measured using bioelectrical impedance analysis (BIA). Body Lean Mass represents the total amount of non-fat body tissue and will be reported in kilograms (kg). | Baseline (onset ), after Prehabilitation intervention (,~4 weeks), post-surgery (Discharge, ~21 days), and Follow-up (~7 days after rehabilitation completion). |
| Phase Angle | Phase angle measured using bioelectrical impedance analysis (BIA). Phase angle is a marker of cellular integrity and body cell mass and will be reported in degrees (°). | Baseline (onset ), after Prehabilitation intervention (,~4 weeks), post-surgery (Discharge, ~21 days), and Follow-up (~7 days after rehabilitation completion). |
| Peak Oxygen Uptake (VO₂peak) | Peak oxygen uptake (VO₂peak) will be assessed during cardiopulmonary exercise testing and reported in liters per minute (L/min). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks). |
| Maximum Work Capacity (Pmax) | Maximum work capacity (Pmax) will be assessed during cardiopulmonary exercise testing and reported in watts (W). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks). |
| Six-minute Walk Test (6MWT) | The Six-minute Walk Test (6MWT) will be used to assess functional exercise capacity. Participants will be instructed to walk at their own pace along a flat, straight 30-meter indoor corridor for six minutes, with the total walking distance recorded in meters (m). Standardized instructions and encouragement will be provided according to established guidelines. | Baseline (prior intervention) after Prehabilitation intervention (~4 weeks), Rehabilitation onset (~63 days post-surgery), after Rehabilitation (~28 days), and Follow-up (~7 days post-Rehabilitation). |
| Timed Up and Go Test (TUG) | The Timed Up and Go Test (TUG) will be used to assess functional mobility. Participants will be instructed to rise from a standard armchair, walk 3 meters at a comfortable and safe pace, turn, return to the chair, and sit down. The total time required to complete the task will be recorded in seconds (s). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Handgrip Strength (HG) | Handgrip strength (HG) will be assessed using a manual hydraulic dynamometer following standardized procedures. Participants will perform maximal voluntary contractions with each hand while seated in a standardized position. The highest value obtained (HGpeak) will be recorded in kilograms (kg) for analysis. | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Hematocrit | Hematocrit measured from venous blood samples. Hematocrit represents the proportion of blood volume occupied by red blood cells and will be reported as a percentage (%). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Vitamin B12 | Serum vitamin B12 concentration measured from venous blood samples and reported in picomoles per liter (pmol/L). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Transferrin Saturation | Transferrin saturation measured from venous blood samples. Transferrin saturation reflects the proportion of transferrin bound to iron and will be reported as a percentage (%). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Hemoglobin Concentration | Hemoglobin concentration measured from venous blood samples. Hemoglobin concentration reflects the oxygen-carrying capacity of the blood and will be reported in grams per deciliter (g/dL). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Ferritin | Serum ferritin concentration measured from venous blood samples. Ferritin reflects body iron stores and will be reported in micrograms per liter (µg/L). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Folate | Serum folate concentration measured from venous blood samples and reported in nanomoles per liter (nmol/L). | Baseline (prior to intervention) and after Prehabilitation intervention (~4 weeks) |
| Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzburger Landeskliniken, University Institute of Sports Medicine, Prevention and Rehabilitation | Salzburg | State of Salzburg | 5020 | Austria |
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| Background |
| Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293. |
| 30193337 | Background | Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645. |
| 35588252 | Background | Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
Not provided
Not provided