Clinical trial NCT02953119: Prehabilitation for Elective Major Abdominal Surgery
Official title: Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prehabilitation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Postoperative morbidity
timeFrame: Up to 30 postoperative days
Secondary outcomes:
measure: Postoperative most severe complication
timeFrame: Up to 30 postoperative days
measure: Length of stay
timeFrame: Up to 30 postoperative days
measure: Readmission rates
timeFrame: Up to 30 postoperative days
measure: Exercise capacity
timeFrame: At 3 and 1 week preoperatively
measure: Life satisfaction
timeFrame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
measure: Biological inflammatory response
timeFrame: Up to 3 postoperative days
measure: Exercise capacity
timeFrame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
measure: Walking capacity
timeFrame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
measure: Happiness
timeFrame: At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
measure: Nutritional response
timeFrame: Up to 3 postoperative days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
Study officials:
affiliation: University Hospital CHUV
name: Martin Hübner
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.