Preop CPET Testing and Exercise Training in Colorectal Patients

NCT01924897 | Unknown DMC

• 1 other identifier: 2013ONC11S
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Neoplasms

Keywords

CPET test; Exercise training; Prehabilitation; Exercise Test

Outcome Measures

Primary Outcomes (1)

• postoperative morbidity

  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.

  First 30 days following surgery

Secondary Outcomes (3)

• post-operative stay

  30 days

• mortality

  30 days

• Admission to HDU/ITU

  30 days

Other Outcomes (1)

• Feasibility outcomes for exercise training

  30 days following surgery

Study Arms (2)

Exercise Training Arm

EXPERIMENTAL

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 Exercise Training Arm

NO INTERVENTION

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.

Interventions

Exercise training BEHAVIORAL

Exercise Training Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Emergency surgery
• 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
• Distant metastases on CT
• American Society of Anaesthesiologists (ASA) physical status IV

Sponsors & Collaborators

• University of East Anglia: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kate Manley, MBBS

CONTACT

07852999083; mrs.g.pickering@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 19, 2013
• Primary Completion: August 1, 2016
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

GB (2)