Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
This trial is active, not recruiting.
|Start date||September 2013|
|End date||December 2016|
|Trial size||50 participants|
|Trial identifier||NCT02586701, MM123|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Six Minute Walk Test (6MWT)
time frame: up to 8 weeks after surgery
Male or female participants from 45 years up to 90 years old.
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).
|Official title||Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients|
|Description||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.|
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