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Preoperative home-based multimodal prehabilitation in patients scheduled for liver or pancreatic resection

Preoperative home-based multimodal prehabilitation in patients scheduled for liver or pancreatic resection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27549
Enrollment
24
Registered
2017-03-23
Start date
2017-05-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In English: liver and pancreatic tumours. In Dutch: lever en pancreas tumoren.

Interventions

Twenty-four patients will participate in a four-week (12 sessions in total) of semi-supervised home-based exercise training before surgery. An advanced cycle ergometer (Lode Corival, Lode BV, Groninge

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Liver tumour (benign tumour, primary cancer, suspicion of a malignancy, or colorectal liver metastasis), pancreatic malignancy, premalignant pancreatic tumour or the suspicion of a pancreatic malignancy requiring resection - Undergoing elective liver (segmental resection or hemihepatectomy) or pancreatic surgery (pancreaticoduodenectomy, subtotal or total pancreatectomy) - Having a life expectancy of more than 6 months - Has given consent to participate in the study - VSAQ score =7 METs - Anaerobic threshold <11 ml/kg/min at the first CPET - Will be operated at MST, UMCG or MMC - Living in Enschede, Oldenzaal, Losser, Lonneker or Glanerbrug (in case of inclusion in MST)

Exclusion criteria

Exclusion criteria: - Not capable to cycle - Not capable to perform a CPET - Meeting the absolute and/or relative exclusion criteria from the CPET protocol used in MST or UMCG. These criteria are based on the criteria from the American Thoracic Society and American College of Chest Physicians Statement on CPET.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the (preliminary) effectiveness of the four-week home-based multimodal prehabilitation program in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, to improve aerobic capacity.

Secondary

MeasureTime frame
Secondary objectives are: - To evaluate the feasibility of a four-week home-based multimodal prehabilitation program in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, as measured by adherence/compliance, adverse events, motivation, patient appreciation - Does the prehabilitation program improve preoperative quality of life, as measured by the Short Form 36 (SF-36)? - Does the prehabilitation program affect other CPET values reflecting aerobic capacity, such as the highest measured oxygen uptake (VO2peak), and oxygen uptake efficiency slope (OUES)? - What is the (preliminary) effect of the prehabilitation program on the physical fitness of an individual patient, as assessed by results on the CPET, steep ramp test, and Lode ergometer data? - What is the (preliminary) effect of prehabilitation on the immune system, by measuring IL-6, IL-8, IL-10, CRP, and TNF-a after the first and prior to the second CPET? - What is the (preliminary) effect of prehabilitation on skeletal muscle metabolic function (energy metabolism)? - Data on operative intervention, perioperative outcomes (i.e. morbidity, mortality, length of hospital stay) and postoperative progress will also be collected, to describe the perioperative course in patients after elective liver or pancreatic resection.

Contacts

Public ContactA.E.M. Berkel

Medisch Spectrum Twente

a.berkel@mst.nl0031620402815

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)