Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01924897
Status:
UNKNOWN
Last Update Posted:
2013-08-19
First Post:
2013-08-14
Brief Title:
Preop CPET Testing and Exercise Training in Colorectal Patients
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
An Investigation Into the Role of Cardiopulmonary Exercise Testing and Pre-operative Exercise Training in Patients Undergoing Major Surgery for Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The study will be conducted in two parts
Part 1 Study to examine the ability of CPET to predict outcomes in patients undergoing colorectal surgery
Objectives
To identify which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery In addition to examine whether CPET variables can be used in combination with other scoring systems or blood tests to increase accuracy of prediction The aim of this investigation is to develop an accurate prediction model from key clinically relevant predictor variables including CPET variables blood tests and risk scoring systems Such a model could be used in clinical practice to predict pre-operative outcome and thus help risk stratify patients for post-operative surveillance or management
Study Population
The Norfolk and Norwich University Hospital undertakes approximately 300 procedures for colorectal cancers per year Patients scheduled for cancer surgery will be recruited to the trial
Study Outline
Informed consent to participate in the trial will be obtained in the outpatient setting after diagnosisscheduling of surgery through discussion with the medical team and the colorectal nurse specialists All patients will follow a standardised peri-operative pathway devised in conjunction with the surgical and anaesthetic team
Sample Size
A sample size of a minimum of 90 patients has been identified based on comparable studies with other patient groups in the literature
Predictor Variables
Supervised pre-operative CPET testing will take place in the exercise laboratory at the University of East Anglia before surgery The test is done by pedalling on a stationary bicycle the resistance to pedalling will gradually increase similar to when cycling up a hill As the subject rides the stationary bike the amount of oxygen used and how fastefficiently their heart beats is calculated Breathing will be measured through a face mask or a mouth piece and the electrical activity of the heart will be measured via sensors placed on the chest Each CPET test takes around 30 minutes to complete For each participant in this part of the study only one CPET test will be done prior to surgery at a convenient time
In addition to the standard pre-surgery blood tests that all NHS patients receive blood will be taken to measure several key serum markers which have been associated with post-operative outcomes in patients undergoing major abdominal surgery pro-BNP CRP albumin and IL-6
Scoring systems will be applied to patient data as additional indicators of peri-operative risk - these are systems which involve calculating a measure of risk based on other co-existing illnesses the patient may have
Data Collection
Patient notes will be reviewed on each postoperative day to identify postoperative complications according to the Post-Operative Morbidity Survey system POMS this is a scoring tool previously used in other studies which assesses different systems of the body to determine morbidity according to defined criteria pulmonary infection renal gastrointestinal cardiovascular wound complications haematological and pain Time taken until pain relief is satisfactory ability to eat and drink satisfactory level of mobilityself-care and bowel function will also be recorded Length of hospital stay and time taken until the patient is medically fit for discharge will also be recorded
Part 2 Feasibility of a randomised prehabilitation programme in patients undergoing surgery for colorectal cancer
Objectives
To determine the feasibility of implementing 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
Study Population as above
Study Outline
Following baseline CPET testing to assess initial background fitness patients will be randomised to one of two study arms
1 a supervised aerobic exercise training pathway standard treatment or
2 standard treatment without supervised exercise training
To adequately assess key feasibility outcomes a sample size of 60 patients 30 in each arm of the study will be used
Patients randomised to exercise training will be offered three sessions of supervised aerobic exercise per week over the subsequent 4 weeks before their procedure to be conducted in the exercise lab at the University of East Anglia
Each session will include a few simple freehand exercises as well as some time on the treadmill or a fixed exercise bike The sessions will last about an hour each and will be tailored to individual fitness levels Heart rate clinical signs blood pressure and perceived exertion will be recorded regularly throughout exercise This exercise protocol is currently in use in a study of elderly patients with bladder cancer awaiting surgery and is well-tolerated
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 CPET variables
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 The data from these patients n30 will be used to contribute to the first part of the study CPET variables as predictors of outcome
All patients will be CPET tested again at 3 months post-surgery to assess how well they have returned to their baseline function following their operation Patients will be given follow-up questionnaires at this time and again at 6 months post-surgery to assess health-related quality of life and psychological outcomes The questionnaires used will be CHAMPS Physical Activity Questionnaire for older adults The Satisfaction with Life Scale Hospital Anxiety and Depression Scale HADS FACT-F and the FACT-C scale to assess disease-specific quality of life
Data collection
As before patient notes will be reviewed and post-operative complications identified In addition this study will 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 compliancetolerance of the exercise regimen and patient satisfaction with the process In addition the costs of undergoing CPET testing and supervised exercise training will be estimated
An assessment of key health outcomes will also be undertaken ie changes in CPET variables following exercise training postoperative complications length of stay and health-related quality of life benefits thus enabling the planning of a larger trial
Part 1 Study to examine the ability of CPET to predict outcomes in patients undergoing colorectal surgery
Objectives
To identify which CPET variables or combination of variables are most useful in the prediction of post-operative complications following colorectal surgery In addition to examine whether CPET variables can be used in combination with other scoring systems or blood tests to increase accuracy of prediction The aim of this investigation is to develop an accurate prediction model from key clinically relevant predictor variables including CPET variables blood tests and risk scoring systems Such a model could be used in clinical practice to predict pre-operative outcome and thus help risk stratify patients for post-operative surveillance or management
Study Population
The Norfolk and Norwich University Hospital undertakes approximately 300 procedures for colorectal cancers per year Patients scheduled for cancer surgery will be recruited to the trial
Study Outline
Informed consent to participate in the trial will be obtained in the outpatient setting after diagnosisscheduling of surgery through discussion with the medical team and the colorectal nurse specialists All patients will follow a standardised peri-operative pathway devised in conjunction with the surgical and anaesthetic team
Sample Size
A sample size of a minimum of 90 patients has been identified based on comparable studies with other patient groups in the literature
Predictor Variables
Supervised pre-operative CPET testing will take place in the exercise laboratory at the University of East Anglia before surgery The test is done by pedalling on a stationary bicycle the resistance to pedalling will gradually increase similar to when cycling up a hill As the subject rides the stationary bike the amount of oxygen used and how fastefficiently their heart beats is calculated Breathing will be measured through a face mask or a mouth piece and the electrical activity of the heart will be measured via sensors placed on the chest Each CPET test takes around 30 minutes to complete For each participant in this part of the study only one CPET test will be done prior to surgery at a convenient time
In addition to the standard pre-surgery blood tests that all NHS patients receive blood will be taken to measure several key serum markers which have been associated with post-operative outcomes in patients undergoing major abdominal surgery pro-BNP CRP albumin and IL-6
Scoring systems will be applied to patient data as additional indicators of peri-operative risk - these are systems which involve calculating a measure of risk based on other co-existing illnesses the patient may have
Data Collection
Patient notes will be reviewed on each postoperative day to identify postoperative complications according to the Post-Operative Morbidity Survey system POMS this is a scoring tool previously used in other studies which assesses different systems of the body to determine morbidity according to defined criteria pulmonary infection renal gastrointestinal cardiovascular wound complications haematological and pain Time taken until pain relief is satisfactory ability to eat and drink satisfactory level of mobilityself-care and bowel function will also be recorded Length of hospital stay and time taken until the patient is medically fit for discharge will also be recorded
Part 2 Feasibility of a randomised prehabilitation programme in patients undergoing surgery for colorectal cancer
Objectives
To determine the feasibility of implementing 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
Study Population as above
Study Outline
Following baseline CPET testing to assess initial background fitness patients will be randomised to one of two study arms
1 a supervised aerobic exercise training pathway standard treatment or
2 standard treatment without supervised exercise training
To adequately assess key feasibility outcomes a sample size of 60 patients 30 in each arm of the study will be used
Patients randomised to exercise training will be offered three sessions of supervised aerobic exercise per week over the subsequent 4 weeks before their procedure to be conducted in the exercise lab at the University of East Anglia
Each session will include a few simple freehand exercises as well as some time on the treadmill or a fixed exercise bike The sessions will last about an hour each and will be tailored to individual fitness levels Heart rate clinical signs blood pressure and perceived exertion will be recorded regularly throughout exercise This exercise protocol is currently in use in a study of elderly patients with bladder cancer awaiting surgery and is well-tolerated
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 CPET variables
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 The data from these patients n30 will be used to contribute to the first part of the study CPET variables as predictors of outcome
All patients will be CPET tested again at 3 months post-surgery to assess how well they have returned to their baseline function following their operation Patients will be given follow-up questionnaires at this time and again at 6 months post-surgery to assess health-related quality of life and psychological outcomes The questionnaires used will be CHAMPS Physical Activity Questionnaire for older adults The Satisfaction with Life Scale Hospital Anxiety and Depression Scale HADS FACT-F and the FACT-C scale to assess disease-specific quality of life
Data collection
As before patient notes will be reviewed and post-operative complications identified In addition this study will 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 compliancetolerance of the exercise regimen and patient satisfaction with the process In addition the costs of undergoing CPET testing and supervised exercise training will be estimated
An assessment of key health outcomes will also be undertaken ie changes in CPET variables following exercise training postoperative complications length of stay and health-related quality of life benefits thus enabling the planning of a larger trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None