Prehabilitation for Elective Major Abdominal Surgery (PISO)

Nicolas DEMARTINES

Status: Terminated

Conditions: Prehabilitation

Treatments: Other: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02953119

469/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

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.

Treatment:

Other: Prehabilitation

Controls

No Intervention group

Description:

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.