Prehabilitation for Elective Major Abdominal Surgery

NCT ID: NCT02953119

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-04-30

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.

Conditions

Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prehabilitation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nicolas DEMARTINES

OTHER

Sponsor Role: lead

Responsible Party

Nicolas DEMARTINES

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Hübner

Role: PRINCIPAL_INVESTIGATOR

University Hospital CHUV

Locations

Department of Visceral Surgery, University Hospital Center

Lausanne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35392968 (View on PubMed)

Other Identifiers

469/15

Identifier Type: -

Identifier Source: org_study_id