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Prehabilitation for Elective Major Abdominal Surgery (PISO)

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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

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.


Condition or disease Intervention/treatment Phase
Prehabilitation Other: Prehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
Study Start Date : October 2016
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 2020

Arm Intervention/treatment
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.
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.



Primary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: Up to 30 postoperative days ]
    Comprehensive Complication Index (CCI)


Secondary Outcome Measures :
  1. Postoperative most severe complication [ Time Frame: Up to 30 postoperative days ]
    Clavien classification

  2. Length of stay [ Time Frame: Up to 30 postoperative days ]
    From the day of hospitalization to the exit

  3. Readmission rates [ Time Frame: Up to 30 postoperative days ]
    Any readmission to the hospital

  4. Exercise capacity [ Time Frame: At 3 and 1 week preoperatively ]
    Exercise testing on a cycloergometer(VO2 max)

  5. 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)

  6. Biological inflammatory response [ Time Frame: Up to 3 postoperative days ]
    C-reactiv protein (CRP) measure

  7. Exercise capacity [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    Time up and go test

  8. Walking capacity [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    6 minutes Walking Test

  9. Happiness [ Time Frame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively ]
    Specific questionnaire (EMMBEP questionnaire)

  10. Nutritional response [ Time Frame: Up to 3 postoperative days ]
    Albumin measure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953119


Locations
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Switzerland
Department of Visceral Surgery, University Hospital Center
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Nicolas DEMARTINES
Investigators
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Principal Investigator: Martin Hübner University Hospital CHUV
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Responsible Party: Nicolas DEMARTINES, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02953119    
Other Study ID Numbers: 469/15
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No