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Clinical Trials/NCT02586701
NCT02586701
Completed
Not Applicable

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

Franco Carli1 site in 1 country134 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Franco Carli
Enrollment
134
Locations
1
Primary Endpoint
Six Minute Walk Test (6MWT)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Franco Carli
Responsible Party
Sponsor Investigator
Principal Investigator

Franco Carli

MD

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

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)
  • Morbid obesity (BMI \> 40)
  • Anemia (hematocrit \< 30%, haemoglobin \< 10g/dl, albumin \< 25mg/dl).

Outcomes

Primary Outcomes

Six Minute Walk Test (6MWT)

Time Frame: up to 8 weeks after surgery

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.

Study Sites (1)

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