Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
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|ClinicalTrials.gov Identifier: NCT02586701|
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Prehabilitation Plus||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 20, 2016|
|Actual Study Completion Date :||December 31, 2016|
Active Comparator: Prehabilitation Plus
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
Supervised exercise program and home-based exercise program.
No Intervention: Rehabilitation
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586701
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3A 1A1|
|Study Chair:||Francesco Carli, MD||McGill University Health Centre/Research Institute of the McGill University Health Centre|