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Preoperative home-based exercise training in patients scheduled for liver or pancreatic resection


- candidate number26950
- NTR NumberNTR6282
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2017
- Secondary IDsNL59702.044.16 P17-08
- Public TitlePreoperative home-based exercise training in patients scheduled for liver or pancreatic resection
- Scientific TitlePreoperative home-based exercise prehabilitation in patients scheduled for liver or pancreatic resection
- ACRONYMPreoperative home-based exercise prehabilitation
- hypothesisWe hypothesize that exercise prehabilitation will improve the preoperative anaerobic threshold, we assume to reach an average increase of 1.5 ml/kg/min, in patients with a low cardiorespiratory reserve (anaerobic threshold <11 ml/kg/min) undergoing elective liver or pancreatic resection.
- Healt Condition(s) or Problem(s) studiedLiver tumor, Pancreas tumor
- 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 or UMCG
- Living in Enschede, Oldenzaal, Losser, Lonneker or Glanerbrug; or in a range of 15 km around UMCG
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-mei-2018
- Target number of participants24
- InterventionsEligible patients with an anaerobic threshold <11 ml/kg/min and no contraindications to physical exercise training as evaluated during the CPET can participate in the study. 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 (Simultrainer, Simultrainer Europe BV, Velp, the Netherlands) will be delivered at the patients’ home. The training program, two sessions a week of interval training at the cycle ergometer and one session a week of endurance training at the cycle ergometer, combined with peripheral muscle training, will be personalized to candidates. The physiotherapist will visit the patient at least weekly to monitor progress and to execute a steep ramp test to optimize the prehabilitation program. Prior to the first and second CPET blood samples will be collected, and interleukin (IL)-6, IL-8, IL-10, C-reactive protein (CRP), and tumour necrosis factor (TNF)-α will be measured.
- Primary outcomeThe primary objective is to evaluate the preliminary effectiveness of a four-week home-based exercise prehabilitation program on an advanced cycle ergometer in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, defined as 1.5 ml/kg/min improvement of the anaerobic threshold on CPET.
- Secondary outcomeSecondary objectives are:
- To evaluate the feasibility of a four-week home-based exercise prehabilitation program on an advanced cycle ergometer 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, 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 Simultrainer data?
- What is the (preliminary) effect of prehabilitation on the immune system, by measuring IL-6, IL-8, IL-10, CRP, and TNF-α prior to the first and second CPET?
- 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.
- TimepointsAt the first clinic attendance potentially eligible patients will be asked to participate in the study. A few days later they will be contacted and informed consent will be obtained. Patients who provide informed consent will undergo a CPET, receive a quality of life questionnaire and venipuncture at T0. Patients with an anaerobic threshold <11 ml/kg/min will participate in a personalized home-base exercise prehabilitation program. After the prehabilitation program patients will undergo a second CPET, receive a second quality of life questionnaire, venipuncture, and an appreciation questionnaire at T1.
- Trial web siteN.A.
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.E.M. Berkel
- CONTACT for SCIENTIFIC QUERIES A.E.M. Berkel
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Department of surgery in Medisch Spectrum Twente, University Medical Center Groningen (UMCG)
- PublicationsNone.
- Brief summaryRationale: Morbidity rates after resection of hepatic and pancreatic tumours are high. Older patients, especially the frail patients, are more prone to complications and require specific preoperative risk stratification in order to eventually tailor necessary prophylactic interventions.
Cardiorespiratory fitness, as indicated by the anaerobic threshold assessed by a cardiopulmonary exercise testing (CPET), can be used to identify high-risk patients.
Preoperative exercise prehabilitation can improve the physical fitness of high-risk patients before intra-abdominal surgery. There is however limited evidence regarding the improvement of cardiorespiratory fitness during and after exercise prehabilitation in patients undergoing liver or pancreatic resection. We hypothesize that exercise prehabilitation will improve the preoperative anaerobic threshold, we assume to reach an average increase of 1.5 ml/kg/min, in patients with a low cardiorespiratory reserve (anaerobic threshold <11 ml/kg/min) undergoing elective liver or pancreatic resection.
Objective: The primary objective is to assess the (preliminary) effectiveness of a 4-week home-based exercise training on an advanced cycle ergometer on preoperative cardiorespiratory fitness as measured by the anaerobic threshold in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection. Secondary outcome measures include to assess the feasibility (adherence, adverse events, motivation, patient appreciation) of the 4-week home-based exercise program, changes in other preoperative CPET measures, changes in preoperative quality of life score, effect of prehabilitation on the immune system by assessing biomarkers, and individual changes in physical fitness and daily physical activity during the prehabilitation program. Data on operative intervention, perioperative outcomes and postoperative progress will also be collected.
Study design: This study is a multicenter study with a pretest – posttest design. It will run from May 2017 till May 2018 and it will take place in Medisch Spectrum Twente in Enschede and Universitair Medisch Centrum Groningen. Potentially eligible candidates who provide informed consent will first undergo a CPET, receive a quality of life questionnaire and venipuncture. Patients with an anaerobic threshold <11 ml/kg/min will participate in a personalized home-base exercise prehabilitation program. After the prehabilitation program patients will undergo a second CPET, receive a quality of life questionnaire, venipuncture, and an appreciation questionnaire.
Study population: Patients planned for elective resection of a liver or pancreatic tumour will be screened for potential eligibility. Patients with a metabolic equivalent score of ≤7 on the Veterans Specific Activity Questionnaire will be invited to participate in the study and will perform a CPET. Patients with an anaerobic threshold <11 ml/kg/min and no contraindications to physical exercise training as evaluated during the CPET can participate in the study.
Intervention: 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 (Simultrainer, Simultrainer Europe BV, Velp, the Netherlands) will be delivered at the patients’ home. The training program, two sessions a week of interval training at the cycle ergometer and one session a week of endurance training at the cycle ergometer, both combined with peripheral muscle training, will be personalized to candidates. The physiotherapist will visit the patient at least weekly to monitor progress and to execute a steep ramp test to optimize the prehabilitation program. Prior to the first and second CPET blood samples will be collected, and interleukin (IL)-6, IL-8, IL-10, C-reactive protein (CRP), and tumour necrosis factor (TNF)-α will be measured.
Main study parameters/endpoints: The primary endpoint of this study is the (preliminary) effectiveness of the four-week home-based exercise prehabilitation program in high-risk patients (anaerobic threshold <11 ml/kg/min) scheduled for elective liver or pancreatic resection, to improve cardiorespiratory fitness. Secondary, the feasibility will be evaluated of the four-week home-based exercise 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. Other secondary endpoints are: 1) changes in other preoperative CPET measures, 2) changes in preoperative quality of life score, 3) effect of prehabilitation on the immune system, 4) and individual changes in physical fitness and daily physical activity during the prehabilitation program.
- Main changes (audit trail)
- RECORD23-mrt-2017 - 8-mei-2017


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