Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients

Study Overview
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Brief Summary
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Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.

Detailed Description
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The aims of this research project are the following: To determine to what extent a structured multimodal prehabilitation regimen, which includes aerobic and resistance exercise, nutritional supplementation and psychological coping strategies, initiated before surgery, and continued while in hospital and after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Official Title
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Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Prehabilitation Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred electively for resection of malignant, non metastasized, colorectal lesions. French or English speaking Exclusion Criteria: ASA class 4-5 co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis) cardiac abnormalities severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5mg/dl, and hepatic failure ALT and AST > 50% over the normal range) Sepsis Morbid obesity (BMI > 40) Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehabilitation Plus<br>Patients in this group will be enrolled in a multimodal program before surgery involving supervised exercise, nutrition counseling and relaxation strategies. Supervised exercise is provided once a week for four weeks before surgery as well as during the hospital stay post surgery. Patients are to continue with a home-based exercise program for 8 weeks after discharge. | Other: Prehabilitation Plus<br>* Supervised exercise program and home-based exercise program.<br>|
| No Intervention: Rehabilitation<br>Patients in this group are provided with in-hospital supervised exercises with a kinesiologist post surgery until discharge. Patients, upon discharge are provided with a home-based exercise program, nutritional counseling and relaxation strategies for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test (6MWT) | Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six-minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines. | up to 8 weeks after surgery |