Digitally Supported Prehabilitation Before Major Visceral Cancer Surgery
A legfontosabb adatok
- Ki végzi
- Ludwig Boltzmann Institute for Digital Health and Prevention
- Hol
- Saint Veit Im Pongau és Salzburg (Ausztria)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 30 fő, tervezett
- Kezdés
- 2026. jún.
- Várható befejezés
- 2027. júl.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Digitally Supported Multimodal Prehabilitation
- A regiszteradat frissítve
- 2026. június 18.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek a hasnyálmirigyen, a májon, az epeutakon, a gyomron vagy a nyelőcsövön nagy daganatműtétre van szükségük. A műtét célja a betegség teljes eltávolítása.
- Életkor
- 18 éves vagy idősebb
- Nem
- Nők és férfiak egyaránt részt vehetnek.
- A betegség stádiuma
- Hasnyálmirigy-, máj-, epeúti, gyomor- vagy nyelőcsőrák. A daganatos betegek konzíliuma megerősítette a műtét szükségességét, amelynek célja a betegség teljes eltávolítása.
A részvétel fő kizáró okai
- 18 évesnél fiatalabb
- Testi fogyatékosság vagy szellemi károsodás, ami akadályozza a biztonságos részvételt
- Sürgős, nem tervezett vagy ismételt (revíziós) műtét
- Heveny egészségi állapot, ami kizárja a szervezett edzésprogramot
- Egészségügyi meghatalmazott, aki nem engedi az önálló beleegyezést
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Non-elective, emergency, or revision surgery
- Physical disability or mental impairment preventing safe participation in the study
- Acute medical condition contraindicating participation in a structured prehabilitation program
- Age younger than 18 years
- Health care medical power of attorney not permitting independent consent
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- Has your doctor told you that the cancer cannot be removed by surgery, or that it has spread to other parts of the body?
- Are you 18 years old or older?
Helyszínek itt: Ausztria
- Rehabilitationszentrum St. Veit im Pongau Betriebs-GmbHSaint Veit Im Pongau, AusztriaContact: Bajtarevic Romana, Dr.No longer taking part
- Department of General, Visceral and Thoracic Surgery, Paracelsus Medical University, Salzburger Landeskliniken, University Institute of Sports Medicine, Prevention and RehabilitationSalzburg, AusztriaContact: Stefan Löb, Priv.-Doz. Dr. med.No longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat csoportja
- Digitally Supported Multimodal PrehabilitationA vizsgált kezelés
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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- From Prehabilitation to Rehabilitation: A Feasibility Trial for Digitally Supported Prehabilitation in Major Visceral Oncologic Surgery
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
- Illeszkedési kérdések
- Forrás: NCT07658313: ki vehet részt
- A regiszteradat frissítve
- 2026. június 18.