Evaluation of a home-based prehabilitation program for high-risk patients undergoing major elective abdominal surgery: a one-group pre-test post-test pilot study.

Morbidity rates after resection of colorectal, hepatic, and pancreatic tumors
are high. Frail patients often have less ability to cope with surgical stress
and hospitalisation, which makes them more prone to complications. They require
specific preoperative risk stratification in order to eventually tailor
necessary preoperative interventions. Cardiorespiratory fitness, as indicated
by the ventilatory anaerobic threshold (AT) assessed by a cardiopulmonary
exercise test (CPET), can be used to identify high-risk patients (AT*11
mL/kg/min). Prehabilitation can improve the physical fitness of these high-risk
patients before major abdominal surgery. However, there is limited evidence
regarding the feasibility of home-based personalized prehabilitation program in
high-risk patients opting for major abdominal surgery. We hypothesize that
home-based personalized prehabilitation is safe with high program
adherence/compliance and high patient appreciation.

The primary objective of this one-group pre-test post-test pilot study is to
assess the feasibility of a home-based personalized prehabilitation program of
approximately four weeks (usual care) in high-risk patients scheduled for
elective colorectal, hepatic, or pancreatic resection.

The secondary objective is to evaluate individual responses to prehabilitation
regarding immune system activity, physical fitness, nutritional status, quality
of life and health status (no cause-effect relationship to be established).
Data on operative intervention, and postoperative recovery outcomes will also
be collected for explorative purposes.

This study is a within subject non-experimental pre-post pilot study. The study
will include high-risk patients (ventilatory AT*11 mL/kg/min) opting for
elective colorectal, hepatic, or pancreatic resection at the Maastricht
University Medical Center (Maastricht UMC+).

Patients who provide informed consent will participate in a four-week (12
sessions in total) semi-supervised home-based personalized prehabilitation
program. The program will be personalized to each patient (activities of
relevance for the patient, progressed on intensity and repetitions, as well as
on complexity and variability, and aiming to improve physical fitness and
physical functioning). The physical therapist will weekly monitor progress
using non-sophisticated tests of functional exercise capacity, muscle strength,
and functional mobility that can be easily executed in a home-based context in
order to optimize the prehabilitation program. Before and after the program
patients will perform a CPET (with blood sampling).

The risk for adverse events is considered negligible. Preoperative physical
therapy (home-based prehabilitation program) for these high-risk patients is
currently usual care at the Maastricht UMC+. In this explorative study, we
collect extra data pre- and post prehabilitation to assess the feasibility and
individual responses of this program. Physical training in patients with cancer
is known to be safe and leads to improvements in physical fitness, as well as
in quality of life. Before final inclusion in the study, a CPET will be
performed to assess the baseline aerobic fitness, as well as to examine whether
there are any contraindications for physical training (safety). The performance
tests (e.g., CPET) are safe and non-invasive in these patients, as reported
previously in studies of West et al. (2014), Heldens et al. (2017), and Levett
et al. (2018).The venipuncture can give some bruising and hematoma at the
venipuncture site. The prehabilitation program is usual care and will be
personalized to each patient based on individual risk factors, preferences and
goals. The training program itself will be executed at a moderate-to-high
exercise intensity. With the weekly monitoring of progression, patients and
their informal caregivers gain (extra) insight in their physical fitness and
physical functioning (usual care).