Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Prehabilitation in Liver Surgery

This study has been completed.
Information provided by (Responsible Party):
Declan Dunne, Aintree University Hospitals NHS Foundation Trust Identifier:
First received: January 30, 2012
Last updated: December 16, 2013
Last verified: February 2012

Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications.

We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again.

We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function.


  1. A short period of exercise can significantly improve fitness prior to liver surgery
  2. Greater Fitness is associated with better liver function.

Condition Intervention Phase
Colorectal Cancer
Colorectal Liver Metastasis
Liver Surgery
Exercise Intervention
Behavioral: Exercise Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.

Resource links provided by NLM:

Further study details as provided by Declan Dunne, Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Anaerobic threshold prior to liver resection [ Time Frame: 4 weeks ]
    This is a measure of cardiopulmonary fitness as detected by a cardiopulmonary exercise test.

Secondary Outcome Measures:
  • Hospital Length of stay [ Time Frame: 6 weeks ]
    length of hospital admission from date of surgery

  • Post operative morbidity [ Time Frame: 3 months ]
    As measured using Clavien classification and postoperative morbidity scores

  • Quality of Life [ Time Frame: 4 months ]
    SF -36 and EORTC questionaires at 5 weeks, 6 weeks postoperatively, and 3 months postoperatively

  • Mortality [ Time Frame: 30 day and 90 day postoperative ]
  • Attendance at exercise sessions [ Time Frame: 6 weeks ]
  • Serious adverse events within exercise program [ Time Frame: 6 weeks ]
    The investigators are not expecting and serious adverse events during the program.

  • other measures of cardiopulmonary function [ Time Frame: 6 weeks ]
    Detected by cardiopulmonary exercise prior to surgery.

  • Recovery of fitness [ Time Frame: 6 and 12 weeks post operatively ]
    recovery of cardiopulmonary exercise test determined fitness post surgery.

Enrollment: 37
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Intervention
4 week personalised exercise program on a static bicycle.
Behavioral: Exercise Intervention
4 week personalised exercise program on a static cycle. Supervised in a hospital environment
No Intervention: Control Arm
Patients having standard preoperative preparation and advice.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Planned resection of colorectal liver metastasis
  • Able to perform cycle based exercise program
  • Age over 18

Exclusion Criteria:

  • Unable to consent
  • Unable to perform cycle based exercise program
  • Age under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01523353

United Kingdom
Aintree University Hospital
Liverpool, Merseyside, United Kingdom, L9 7AL
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Principal Investigator: Declan FJ Dunne, MBChB(Hons) Aintree University Hospitals NHS Foundation Trust
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Declan Dunne, Surgical Research Fellow, Aintree University Hospitals NHS Foundation Trust Identifier: NCT01523353     History of Changes
Other Study ID Numbers: 11/H1005/3
Study First Received: January 30, 2012
Last Updated: December 16, 2013

Keywords provided by Declan Dunne, Aintree University Hospitals NHS Foundation Trust:
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases processed this record on May 25, 2017