| الوصف: |
BACKGROUND Morbidity rates in pancreatic surgery are high, and especially frail patients with low aerobic capacity are at risk of complications and require specialized prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes. OBJECTIVE In this study we aim to assess the feasibility of a home-based exercise prehabilitation program in unfit patients scheduled for pancreatic surgery on a larger scale. METHODS In this multicenter study adult patients scheduled for elective pancreatic surgery, with a preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold ≤13 mL/kg/min and/or a VO2 at peak exercise (VO2peak) ≤18 mL/kg/min will be recruited. The study will be conducted in a pretest-posttest design. A total of 30 patients will be included in the four-week home-based, partly supervised exercise prehabilitation program on an advanced cycle ergometer. The program comprises 30-minute high-intensity interval training three times a week. Training intensity will be based on a steep ramp test (i.e., an abbreviated maximum exercise test on the advanced ergometer) performance, aiming to improve aerobic fitness. Twice a week, patients will perform functional task exercises to improve muscle function and functional mobility. Every week, a steep ramp test will be repeated, and training intensity will be adjusted accordingly. Next to assessing feasibility (participation rate, reasons for non-participation, adherence, dropout rate, reasons for dropout, adverse events, and patient and therapist appreciation) of this exercise prehabilitation program, we will evaluate individual patient’s responses to prehabilitation on aerobic capacity, functional mobility, body composition, perceived fatigue, quality of life, muscle function, and immune system factors. RESULTS - CONCLUSIONS Results of this study will provide important clinical and scientific knowledge on the feasibility of a partly supervised home-based exercise prehabilitation program in a vulnerable patient population. This might ease the path to implementing prehabilitation programs in unfit patients undergoing complex abdominal surgery, such as pancreatic surgery. CLINICALTRIAL This study was approved by the Medical Research Ethics Committee of the Maastricht University Medical Center+ (METC azM/UM), the Netherlands (registration number METC20-090, NL75340.068.20, September 2021) and is registered in the Clinicaltrials.gov register (NCT05496777). |
