Feasibility of supervised home-based exercise prehabilitation in patients scheduled for pancreatic resection

Morbidity rates after resection of pancreatic tumors are high. Older patients,
especially the frail patients, are more prone to complications and require
specific preoperative risk stratification in order to eventually tailor
necessary prophylactic interventions. Aerobic capacity, as indicated by the
anaerobic threshold assessed by a cardiopulmonary exercise test (CPET), can be
used to identify high-risk patients. Preoperative exercise prehabilitation can
improve the physical fitness (e.g., aerobic capacity) of high-risk patients
before intra-abdominal surgery. There is however limited evidence regarding the
feasibility of supervised home-based exercise prehabilitation in patients
undergoing pancreatic resection. We hypothesize that the participation rate for
supervised home-based prehabilitation is >50%, as well as that the program is
safe in participating patients with a high program adherence/compliance and a
high patient and therapist appreciation.

The primary objective of study is to assess the feasibility (participation
rate, reasons for non-participation, adherence/compliance, dropout rate,
reasons for dropout, adverse events, patient motivation, patient appreciation,
and therapist appreciation) 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 aerobic capacity, body composition, functional mobility,
immune system function, perceived fatigue, and quality of life (no cause-effect
relationship to be established). When possible, muscle function will be
evaluated before and after the intervention. Data on patient characteristics,
neoadjuvant therapy, surgical procedure, and 30-day postoperative outcomes will
also be collected for explorative purposes.

This study is a pragmatic multicenter study with a pretest-posttest design. It
will take place at the Maastricht University Medical Center+ in Maastricht, the
Netherlands, at University Medical Center Groningen in Groningen, the
Netherlands, and at the 'Città della Salute e della Scienza' Hospital in
Torino, Italy. Eligible patients will participate in a four-week (partly)
supervised home-based prehabilitation program.

Patients will participate in a four-week (partly) supervised home-based
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. The training program, three sessions a week of
interval training at the cycle ergometer to improve aerobic capacity and muscle
function, combined with functional task exercise training to improve muscle
function and functional mobility, will be personalized to participants. A
trained physical therapist will visit the patient at least weekly (3 times in
week 1 and 1 time in week 2, 3, and 4) to monitor progress and to optimize the
prehabilitation program.

The risk for adverse events is slightly increased because of the
prehabilitation program. However, before the start of the training program, a
CPET will be performed under controlled conditions under the guidance of
trained employees to assess baseline aerobic capacity, as well as to examine
whether or not there are contraindications for physical exercise training
(safety). The exercise prehabilitation program will be personalized to each
patient based on individual steep ramp test results. The training program
itself will be executed at a moderate-to-high exercise intensity. We think the
slightly increased risk is justified because of the expectation that the
intervention will lead to better preoperative physical fitness and subsequently
to better treatment outcomes.