Prehabilitation for Elective Major Abdominal Surgery

Study Overview
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Brief Summary
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Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.

Detailed Description
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Major abdominal surgery is a great stressor to patients and causes large physiological changes, leads to tissue trauma, immobility, psychological distress and reduced quality of life. Physical capacity appears to be an important predictor for postoperative recovery after major abdominal surgery. Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. More specifically prior to major abdominal surgery, preoperative exercise therapy is associated with improved physical fitness of patients, but whether or not this results in fewer complications or faster convalescence remains unclear. The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.

Official Title
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Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial

Conditions
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Prehabilitation

Intervention / Treatment
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* Other: Prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective major abdominal surgery: Esophagus, stomach Liver, pancreas Small intestine, colon, rectum Benign or malignant disease Other intra-abdominal open or laparoscopic surgery lasting> 2 hours Delay of 3 weeks between consultation and surgery Exclusion Criteria: Patient < 18 years, consent not obtained Coronary artery disease (≥ stage III according to CCS) Heart disease (≥ stage III according to NYHA) Uncontrolled cardiac arrhythmias COPD (GOLD stage ≥ III) Physical inability to ride a bike Orthopedic surgery in the last 6 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>The patients will undergo an exercise test on a cycle ergometer (VO2 max), a grip strength test (Jamar dynamometer), a Time Up and Go (TUG) test and a 6 Minutes Walking Test (6-MWT), before and after prehabilitation. Intervention involves 3 training sessions per week during 3 weeks preoperatively, according to the high intensity interval training model, wich consists of: 5 minute warm-up (50% of Cardiopulmonary exercise testing, CPET) Two 10 minute series of 15 sec sprint intervals (100%) interspersed by 15 sec pauses and a 4 min rest between the two series Cool down with a 5 min active recovery period (30%) The grip strength test (Jamar dynamometer), TUG-test and 6-MWT will be repeated between 4 and 6 weeks and 8 and 10 week postoperatively. | Other: Prehabilitation<br> <br> |
| No Intervention: Controls<br>The patients will also undergo an exercise test on a cycle ergometer, a grip strength test (Jamar dynamometer), a TUG-test and a 6-MWT, but only once preoperatively, and between 4 and 6 weeks and 8 and 10 week postoperatively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Comprehensive Complication Index (CCI) | Up to 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative most severe complication | Clavien classification | Up to 30 postoperative days | 
| Length of stay | From the day of hospitalization to the exit | Up to 30 postoperative days | 
| Readmission rates | Any readmission to the hospital | Up to 30 postoperative days | 
| Exercise capacity | Exercise testing on a cycloergometer(VO2 max) | At 3 and 1 week preoperatively | 
| Life satisfaction | Specific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer) | At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively | 
| Biological inflammatory response | C-reactiv protein (CRP) measure | Up to 3 postoperative days | 
| Exercise capacity | Time up and go test | At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively | 
| Walking capacity | 6 minutes Walking Test | At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively | 
| Happiness | Specific questionnaire (EMMBEP questionnaire) | At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively | 
| Nutritional response | Albumin measure | Up to 3 postoperative days |