Home-based Prehabilitation in Pancreatic Resection

NCT05496777 | Completed DMC

• 1 other identifier: NL75340.068.20
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Preoperative Physical Exercise Training; Aerobic Capacity; Aerobic Fitness; Functional Mobility; Cancer; Weight, Body; Cancer of Pancreas

Keywords

Physical activity; Aerobic capacity; Body composition; Functional mobility; Pre-treatment rehabilitation; Pancreatic resection

Outcome Measures

Primary Outcomes (8)

• Participation rate

  Rate of eligible patients that participate in the prehabilitation program

  At recruitment

• Reasons for non-participation

  Patient's reasons for non-participation in the prehabilitation program while being eligible

  At recruitment

• Adherence/compliance

  Adherence rate to the prehabilitation program

  4-week training period

• Dropout rate

  Dropout rate of the prehabilitation program

  4-week training period

• Reasons for dropout

  Participant's reasons for dropping out the prehabilitation program

  4-week training period, at moment of drop-out

• Adverse events

  Any undesirable experience occurring to a participant during the study, whether or not considered related to the experimental supervised home-based prehabilitation program

  4-week training period

• Patient appreciation

  Patient appreciation measured via an appreciation questionnaire

  at the end of 4-week training period

• Therapist appreciation

  Therapist appreciation measured via an appreciation questionnaire

  at the end of 4-week training period

Secondary Outcomes (8)

• Aerobic capacity

  4 weeks (pre- and post-prehabiltation)

• Muscle function

  4 weeks (pre- and post-prehabiltation)

• Body composition

  4 weeks (pre- and post-prehabiltation)

• Functional mobility/muscle strength

  4 weeks (pre- and post-prehabiltation)

• Functional mobility/muscle strength

  Weekly during 4-week training period

Study Arms (1)

Intervention arm

OTHER

Patients planned for pancreatic resection will be included for a home-based prehabilitation program.

Procedure: Home-based prehabilitation program

Interventions

Home-based prehabilitation program PROCEDURE

The home-based prehabilitation program will consist of a four-week program, where patients are expected to perform a high-intensity interval training on a home-trainer combined with functional mobility training three times a week. The program is partly supervised by a trained physiotherapist.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicole Hildebrand: lead
• University Medical Center Groningen: collaborator
• University of Turin, Italy: collaborator

Study Sites (3)

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (44)

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• Hildebrand ND, Wijma AG, Bongers BC, Rensen SS, den Dulk M, Klaase JM, Olde Damink SWM. Adherence and response to supervised home-based exercise prehabilitation of unfit patients scheduled for pancreatic surgery. Eur J Surg Oncol. 2025 Oct;51(10):110302. doi: 10.1016/j.ejso.2025.110302. Epub 2025 Jul 4.

  PMID: 40652824 DERIVED

• Hildebrand ND, Wijma AG, Bongers BC, Rensen SS, den Dulk M, Klaase JM, Olde Damink SWM. Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. JMIR Res Protoc. 2023 Sep 7;12:e46526. doi: 10.2196/46526.

  PMID: 37676715 DERIVED

MeSH Terms

Conditions

Neoplasms; Body Weight; Pancreatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Steven Olde Damink, M.D., M.Sc., PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD-candidate HPB-Surgery

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 11, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

IT (1); NL (2)