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

Franco Carli134 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

134

Conditions

Colorectal Cancer

Interventions

Prehabilitation PlusOTHER

Supervised exercise program and home-based exercise program.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Montreal General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: up to 8 weeks after surgery

Data from ClinicalTrials.gov

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