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Prehabilitation in Liver Surgery

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ClinicalTrials.gov Identifier: NCT01523353
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Declan Dunne, Aintree University Hospitals NHS Foundation Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Liver Metastasis Liver Surgery Exercise Intervention Behavioral: Exercise Intervention Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.
Study Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. Hospital Length of stay [ Time Frame: 6 weeks ]
    length of hospital admission from date of surgery

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

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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523353


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: February 2012

Keywords provided by Declan Dunne, 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