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| Name | Class |
|---|---|
| University of Hull | OTHER |
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Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the mainstay of curative therapy. With the screening program enabling early detection, surgery plays an important role in treatment strategies. Surgery imparts a significant physiological and psychological stress on cancer patients.Recent research has demonstrated that a fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake can improve outcomes by reducing the physiological stress response to surgery. The primary objective of this study is to determine whether a defined exercise programme can improve recovery and reduce complications after surgery.
Study Design
This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism, subjects and investigators will not be blinded to treatment allocation. The study is not blinded because it is impossible to blind investigators or patients to the exercise programme.
Patients undergoing major resectional surgery for colorectal cancer will be recruited from the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be recruited for this pilot study and randomly allocated into 2 groups as outlined below.
The study will necessitate all participants being involved in a baseline assessment which will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs will be met.
All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48 hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical purposes at these stages in all patients as part of routine preoperative assessment prior to colorectal surgery. The aim of this is to permit an analysis of possible changes in antioxidant status prior to surgery but after preconditioning. This would be in addition to routine blood samples required.
The two groups in this study are described in more detail below. Both groups shall receive the same standard care as is normal for patients undergoing colorectal resection surgery. The only difference between groups shall be the addition of exercise preconditioning sessions to group 1. We anticipate that these will be three times a week and lasting of 60-90 minutes duration each. Travel costs will be met.
Groups
The 60 patients in this study will be randomised to one of two groups as follows:
Research hypothesis 1
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not reduce post-surgical length of hospital stay in colorectal cancer patients.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will reduce post-surgical length of hospital stay in colorectal cancer patients.
Research hypothesis 2
H0 - A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will not modify the body's defence systems against a future oxidative stress.
H1- A two to four week period of low to moderate intensity exercise prior to surgery using an individualised exercise intervention will modify the body's defence systems against a future oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard pre-operative care | |
| Exercise | Experimental | A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. ' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Post-operative hospital length of stay until medically fit for discharge. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant capacity | Biochemical markers of antioxidant capacity: Hsp 32/72, CD11b/CD18 and Glutathione measured pre- and post-intervention. | Up to 4 weeks |
| Exercise capacity | Exercise test and CPEX parameters assessed pre-intervention, post-intervention and at 3 months post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hartley, MD FRCS | Hull and East Yorkshire NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Surgical Unit, Castle Hill Hospital | Hull | East Yorkshire | HU16 5JQ | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Up to 3 months |
| Complications | All post-operative complications assessed at 3 months post surgery. | Up to 3 months |
| Quality of Life Questionnaires | Validated QOL questionnaires completed pre-intervention, post-intervention and at 3 months post surgery. | Up to 3 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |