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

Completed

Conditions: pancreas tumoren
liver and pancreatic tumours
10019815
10043413

Registration Number: NL-OMON50320

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

- Liver tumour (benign tumour, primary cancer, suspicion of a malignancy, or
colorectal liver metastasis), or pancreatic tumour (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
- Metabolic equivalent score of *7 on the Veterans Specific Activity
Questionnaire
- Anaerobic threshold <11 ml/kg/min after the first CPET
- Will be operated at Medisch Spectrum Twente at Enschede, Universitair Medisch
Centrum Groningen (UMCG) or Maxima Medisch Centrum (MMC)
- Living in Enschede, Oldenzaal, Losser, Lonneker or Glanerbrug

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 Medisch Spectrum Twente, UMCG or MMC

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is to assess the (preliminary) effectiveness<br /><br>of a 4-week home-based exercise training on an advanced cycle ergometer and the<br /><br>administration of nutritional supplements on preoperative cardiorespiratory<br /><br>fitness as measured by the anaerobic threshold in high-risk patients (anaerobic<br /><br>threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary, we will investigate the feasibility of the prehabilitation program<br /><br>in this patient group by the registration of the number and severity of adverse<br /><br>events, adherence to the program, patient motivation before and after each<br /><br>training session, and patient appreciation questionnaire after four weeks.<br /><br>Other secondary outcome measures include changes in quality of life before and<br /><br>after the prehabilitation program, changes in steep ramp test outcomes, the<br /><br>effect of the exercise program on the immune system, changes in other CPET<br /><br>values, individual changes in physical fitness during the prehabilitation<br /><br>program, and skeletal muscle metabolic function (energy metabolism). Data on<br /><br>operative intervention, perioperative outcomes and postoperative progress will<br /><br>also be collected.</p><br>