Prehabilitation for Elective Major Abdominal Surgery

NCT02953119 | Terminated

• 1 other identifier: 469/15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Postoperative morbidity

  Comprehensive Complication Index (CCI)

  Up to 30 postoperative days

Secondary Outcomes (10)

• Postoperative most severe complication

  Up to 30 postoperative days

• Length of stay

  Up to 30 postoperative days

• Readmission rates

  Up to 30 postoperative days

• Exercise capacity

  At 3 and 1 week preoperatively

• Life satisfaction

  At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Controls

NO INTERVENTION

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.

Interventions

Prehabilitation OTHER

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolas DEMARTINES: lead

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35392968 DERIVED

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Martin Hübner

  University Hospital CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)