Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatment prehabilitation plus
Phase phase 3
Sponsor Franco Carli
Start date September 2013
End date December 2016
Trial size 50 participants
Trial identifier NCT02586701, MM123

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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.
prehabilitation plus
Supervised exercise program and home-based exercise program.
(No Intervention)
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.

Primary Outcomes

Measure
Six Minute Walk Test (6MWT)
time frame: up to 8 weeks after surgery

Eligibility Criteria

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by McGill University Health Center.