Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preop CPET Testing and Exercise Training in Colorectal Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924897
Recruitment Status : Unknown
Verified August 2013 by University of East Anglia.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2013
Last Update Posted : August 19, 2013
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of East Anglia

Brief Summary:

Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal surgery team at the Norfolk and Norwich University Hospital and the University of East Anglia to look at the role of exercise before surgery to improve recovery following an operation.

Having an operation to remove part of the bowel puts physical stress on the body. We know that training can help the body cope with physical stress in the same way that an athlete trains before a competition. We hypothesise that the body may recover more quickly if it is trained prior to an operation with regular and simple exercises.

Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart and muscles at rest and during exercise. CPET testing is often done as part of standard pre-operative assessment in many hospitals for patients before undergoing major surgery. Some studies have demonstrated that CPET can be used to predict outcomes following surgery (such as time taken till discharge, complication rates).

The study consists of two parts:

Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test to determine baseline fitness. Blood tests will be taken around the time of surgery to examine whether biochemical markers in the bloodstream (when used in combination with results from the CPET test) can predict outcomes and recovery following colorectal surgery. Patients will then be monitored to assess their speed of recovery and rate of complications following surgery.

This will enable us to determine which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery.

2) The second study will consist of an exercise intervention involving several sessions of supervised exercise in a laboratory. Before and at the end the exercise training regime, CPET measurements will be taken to see if fitness has improved with exercise.

This part of of the study is to determine if it is feasible to implement a structured, supervised exercise programme for patients awaiting elective colorectal cancer surgery. The results of this study will be used to inform a larger randomised controlled trial to examine the influence of exercise on CPET variables and postoperative outcomes.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Exercise training Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: An Investigation Into the Role of Cardiopulmonary Exercise Testing and Pre-operative Exercise Training in Patients Undergoing Major Surgery for Colorectal Cancer
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Training Arm

Patients randomised to exercise training will be offered three sessions of aerobic interval exercise per week over the subsequent 4 weeks prior to their procedure. Each session will comprise 6 x 5 min repetitions at 60-80% peak VO2, with 2.5 min rest intervals. The aim will be to quickly progress patients to exercise intensities that correspond to and exceed the individual AT. Heart rate, clinical signs, blood pressure and perceived exertion will be recorded regularly throughout exercise.

Repeat CPET testing will then take place 4 weeks from the baseline test in the exercise laboratory (on the day prior to surgery) to determine changes (if any) in AT, VO2, VE/VCO2.

Behavioral: Exercise training
No Intervention: No Exercise Training Arm
The patients in the non-exercise arm of the study will not undergo any exercise intervention but will be CPET tested in the exercise laboratory at the same time points as the exercise arm patients.



Primary Outcome Measures :
  1. postoperative morbidity [ Time Frame: First 30 days following surgery ]
    Patient notes will be reviewed on each postoperative day to identify incidence of postoperative complications according to the Post-Operative Morbidity Survey system (POMS), a validated 18-item scoring tool which assesses nine domains of morbidity relevant to the post-surgical patient according to precisely defined criteria (pulmonary, infection, renal, gastrointestinal, cardiovascular, wound complications, haematological and pain.


Secondary Outcome Measures :
  1. post-operative stay [ Time Frame: 30 days ]
    total postoperative hospital stay (days postop), (including the length of stay for those patients who are readmitted to hospital within 30 days of their surgery),

  2. mortality [ Time Frame: 30 days ]
    mortality in the first 30 days following surgery will be recorded

  3. Admission to HDU/ITU [ Time Frame: 30 days ]
    The need for transfer from ward-level care to higher level care (high dependency or intensive care) following surgery


Other Outcome Measures:
  1. Feasibility outcomes for exercise training [ Time Frame: 30 days following surgery ]

    The primary outcomes of this study are to assess the feasibility of conducting this trial on a larger scale: to identify the number of eligible patients, recruitment rate, willingness of patients to be randomised, willingness of clinicians to participate in the trial, compliance/tolerance of the exercise regimen, patient satisfaction with the process and attrition. In addition, the costs of undergoing CPET testing and supervised exercise training will be estimated.

    An assessment of the characteristics/variability of key health outcomes will also be undertaken, i.e. changes in CPET variables following exercise training, postoperative complications, length of stay, and health-related quality of life benefits, thus enabling identification of a suitable primary outcome measure and sample size calculation for a larger trial.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. Colorectal malignancy suitable for curative resection, no metastatic disease
  3. Elective procedure, ability to undergo CPET testing
  4. American Society of Anaesthesiologists (ASA) physical status I-III

Exclusion Criteria:

  1. Emergency surgery
  2. Unable to participate due to any of the following absolute contraindications to CPET testing: acute MI in past 3 - 5 days; Unstable angina; Uncontrolled arrhythmias; Syncope; Active endocarditis; Symptomatic severe aortic stenosis; Acute PE; DVT; Uncontrolled asthma; Pulmonary oedema; Room air desaturation at rest <85%; Respiratory failure; Cognitive impairment leading to inability to cooperate
  3. Distant metastases on CT
  4. American Society of Anaesthesiologists (ASA) physical status IV

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): NCT01924897


Contacts
Layout table for location contacts
Contact: Kate Manley, MBBS 07852999083 mrs.g.pickering@gmail.com

Locations
Layout table for location information
United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom, NR4 7TJ
Principal Investigator: Kate Manley, MBBS         
Sub-Investigator: John Saxton         
Sub-Investigator: James Hernon         
Sub-Investigator: Jurgens Nortje         
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Principal Investigator: Kate Manley         
Sub-Investigator: John Saxton         
Sub-Investigator: James Hernon         
Sub-Investigator: Jurgens Nortje         
Sponsors and Collaborators
University of East Anglia
National Institute for Health Research, United Kingdom
Layout table for additonal information
Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT01924897    
Other Study ID Numbers: 2013ONC11S
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013
Keywords provided by University of East Anglia:
CPET test
Exercise training
Prehabilitation
Exercise Test
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases