NCT05496777

Home-based Prehabilitation in Pancreatic Resection

Completed NA Last updated 5 August 2024

What this trial tests

NA trial testing Home-based prehabilitation program in Preoperative Physical Exercise Training in 45 participants. Completed in 1 December 2023.

Timeline

1 January 2022

Primary endpoint
1 December 2023

1 December 2023

Quick facts

Lead sponsor	Nicole Hildebrand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	45
Start date	1 January 2022
Primary completion	1 December 2023
Estimated completion	1 December 2023
Sites	3 locations across Italy, Netherlands

Drugs / interventions tested

• Home-based prehabilitation program

Conditions studied

• Preoperative Physical Exercise Training — all drugs for Preoperative Physical Exercise Training →
• Aerobic Capacity — all drugs for Aerobic Capacity →
• Aerobic Fitness — all drugs for Aerobic Fitness →
• Functional Mobility — all drugs for Functional Mobility →

Sponsor

Nicole Hildebrand

Who can join

18 and older, any sex, with Preoperative Physical Exercise Training or Aerobic Capacity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adherence and response to supervised home-based exercise prehabilitation of unfit patients scheduled for pancreatic surgery.
   Hildebrand ND, Wijma AG, Bongers BC, Rensen SS, et al · · 2025 · cited 6× · PMID 40652824 · DOI 10.1016/j.ejso.2025.110302
2. Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study.
   Hildebrand ND, Wijma AG, Bongers BC, Rensen SS, et al · · 2023 · cited 4× · PMID 37676715 · DOI 10.2196/46526
3. Supervised (Home-Based Exercise) Prehabilitation Program in Pancreatic Cancer Patients Undergoing to Neoadjuvant Chemotherapy: A Pilot Feasibility Study.
   Boccia G, Beratto L, Tarperi C, Rainoldi A, et al · · 2026 · PMID 42029608 · DOI 10.3390/medsci14020184
4. Supervised home-based exercise prehabilitation in unfit patients scheduled for pancreatic surgery: study protocol of a multicenter feasibility study
   Hildebrand ND, Wijma AG, Bongers BC, Rensen SS, et al · · 2022 · DOI 10.21203/rs.3.rs-2297523/v1