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Prehabilitation in Liver Surgery

This study is currently recruiting participants.
Verified February 2012 by Aintree University Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Declan Dunne, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01523353
First received: January 30, 2012
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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.

Hypothesis

  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Anaerobic threshold prior to liver resection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    length of hospital admission from date of surgery

  • Post operative morbidity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    As measured using Clavien classification and postoperative morbidity scores

  • Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    SF -36 and EORTC questionaires at 5 weeks, 6 weeks postoperatively, and 3 months postoperatively

  • Mortality [ Time Frame: 30 day and 90 day postoperative ] [ Designated as safety issue: Yes ]
  • Attendance at exercise sessions [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Serious adverse events within exercise program [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The investigators are not expecting and serious adverse events during the program.

  • other measures of cardiopulmonary function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Detected by cardiopulmonary exercise prior to surgery.

  • Recovery of fitness [ Time Frame: 6 and 12 weeks post operatively ] [ Designated as safety issue: No ]
    recovery of cardiopulmonary exercise test determined fitness post surgery.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523353

Contacts
Contact: Declan FJ Dunne, MBChB(Hons) 01515292740 declan.dunne@aintree.nhs.uk

Locations
United Kingdom
Aintree University Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L9 7AL
Contact: Declan FJ Dunne, MBChB(Hons)     015292740     declan.dunne@aintre.nhs.uk    
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Declan FJ Dunne, MBChB(Hons) Aintree University Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Declan Dunne, Surgical Research Fellow, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01523353     History of Changes
Other Study ID Numbers: 11/H1005/3
Study First Received: January 30, 2012
Last Updated: February 6, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Aintree University Hospitals NHS Foundation Trust:
Prehabilitation
Exercise
Colorectal Cancer
Surgery

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013