Prehabilitation for Elective Major Abdominal Surgery (PISO)

Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Prehabilitation
• Intervention / Treatment: Other: Prehabilitation

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Department of Visceral Surgery, University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nicolas DEMARTINES
• Investigators: Principal Investigator: Martin Hübner, University Hospital CHUV

Publications and helpful links

General Publications

• Michel A, Gremeaux V, Muff G, Pache B, Geinoz S, Larcinese A, Benaim C, Kayser B, Demartines N, Hubner M, Martin D, Besson C. Short term high-intensity interval training in patients scheduled for major abdominal surgery increases aerobic fitness. BMC Sports Sci Med Rehabil. 2022 Apr 7;14(1):61. doi: 10.1186/s13102-022-00454-w.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 469/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO