Home-based Prehabilitation in Pancreatic Resection

Rationale: The complication rate after pancreatic resection is high, especially in elderly and physically unfit patients. Aerobic capacity, as indicated by the ventilatory anaerobic threshold (VAT) assessed by a cardiopulmonary exercise test (CPET), can be used to identify high-risk patients. Previous studies have demonstrated that exercise prehabilitation can increase aerobic capacity in patients scheduled for intra-abdominal surgery, subsequently leading to better treatment outcomes. There is limited evidence on the feasibility of a (partly) supervised home-based prehabilitation program in patients scheduled for pancreatic resection. Objective: The primary objective of this study is to assess the feasibility of a four-week supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. Secondary objectives are to evaluate individual responses to prehabilitation on a number of secondary endpoints (no cause-effect relationship to be established). Study design: This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, and at the 'Città della Salute e della Scienza' in Torino, Italy. Study population: Patients planned for elective resection of a pancreatic tumor will be screened for potential eligibility. High-risk patients, identified by an oxygen uptake (VO2) at VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, will be asked to participate. Intervention: A total of 45 patients will participate in a four-week (partly) supervised home-based personalized exercise training program before surgery (12 sessions in total). An advanced cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands) will be delivered at the patient's home. Three weekly sessions of high-intensity interval training on the cycle will be combined with functional task exercise training. A trained physical therapist will visit the patient at least weekly to monitor progress. Main study parameters: The main study parameter is feasibility of the (partly) supervised home-based prehabilitation program. Hereto participation rate and reasons for non-participation will be evaluated. In participating patients, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation will be assessed throughout the program. Secondary endpoints: Secondary endpoints before and after prehabilitation include aerobic capacity, muscle function, body composition, functional mobility, immune system function, perceived fatigue, quality of life, and sarcopenia. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* An oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) ≤13 ml/kg/min and/or an VO2peak ≤18 ml/kg/min assessed using cardiopulmonary exercise testing
* Age ≥18 years
* Scheduled for elective pancreatic resection at Maastricht UMC+, at the University Medical Center Groningen, or the Citta della Salute e della Scienza Hospital in Torino
* Willing to participate in the home-based prehabilitation program
* Providing informed consent to participate

Exclusion Criteria:

* Patients requiring acute (emergency) surgery;
* Patients undergoing surgery in another hospital;
* Patients not living within the catchment area of the hospital (\<30 minutes);
* Patients not capable of cycling on a cycle ergometer;
* Patients with contraindications for physical exercise training;
* Unable to cooperate with the testing procedures (e.g., insufficient understanding of the Dutch or Italian language at the Maastricht University Medical Center+, at the University Medical Center Groningen, or at the 'Città della Salute e della Scienza' Hospital in Torino, respectively);
* No physical therapist with the right education (functional task training/home based prehabilitation) available in the living area of the patient.

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