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Prehabilitation for Elective Major Abdominal Surgery (PISO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953119
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : November 2, 2016
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date June 23, 2020
Study Start Date  ICMJE October 2016
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Postoperative morbidity [ Time Frame: Up to 30 postoperative days ]
Comprehensive Complication Index (CCI)
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
Postoperative morbidity [ Time Frame: 30 days ]
Comprehensive Complication Index
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Postoperative most severe complication [ Time Frame: Up to 30 postoperative days ]
    Clavien classification
  • Length of stay [ Time Frame: Up to 30 postoperative days ]
    From the day of hospitalization to the exit
  • Readmission rates [ Time Frame: Up to 30 postoperative days ]
    Any readmission to the hospital
  • Exercise capacity [ Time Frame: At 3 and 1 week preoperatively ]
    Exercise testing on a cycloergometer(VO2 max)
  • Life satisfaction [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    Specific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer)
  • Biological inflammatory response [ Time Frame: Up to 3 postoperative days ]
    C-reactiv protein (CRP) measure
  • Exercise capacity [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    Time up and go test
  • Walking capacity [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    6 minutes Walking Test
  • Happiness [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    Specific questionnaire (EMMBEP questionnaire)
  • Nutritional response [ Time Frame: Up to 3 postoperative days ]
    Albumin measure
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Postoperative morbidity [ Time Frame: 30 days ]
    Clavien classification
  • Length of stay [ Time Frame: 30 days ]
  • Readmission rates [ Time Frame: 30 days ]
  • Exercise capacity [ Time Frame: 30 days ]
    Exercise testing (VO2 max)
  • Quality of life [ Time Frame: 30 days ]
    EORTC questionnaire
  • Metabolic stress response [ Time Frame: 3 days ]
    CRP measure
  • Exercise capacity [ Time Frame: 30 days ]
    Time up and go test
  • Exercise capacity [ Time Frame: 30 days ]
    6 minutes Walking Test
  • Quality of life [ Time Frame: 30 days ]
    EMMBEP questionnaire
  • Metabolic stress response [ Time Frame: 3 days ]
    Albumin measure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehabilitation for Elective Major Abdominal Surgery
Official Title  ICMJE Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
Brief Summary

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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prehabilitation
Intervention  ICMJE Other: Prehabilitation
Study Arms  ICMJE
  • Experimental: Prehabilitation

    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.
    Intervention: Other: Prehabilitation
  • No Intervention: Controls
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
150
Actual Study Completion Date  ICMJE April 2020
Actual Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953119
Other Study ID Numbers  ICMJE 469/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicolas DEMARTINES, University of Lausanne Hospitals
Study Sponsor  ICMJE Nicolas DEMARTINES
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Hübner University Hospital CHUV
PRS Account University of Lausanne Hospitals
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP