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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
Sponsor:
Information provided by (Responsible Party):
Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Prehabilitation Plus Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  • Sepsis
  • Morbid obesity (BMI > 40)
  • Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Franco Carli
Investigators
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Study Chair: Francesco Carli, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:
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Responsible Party: Franco Carli, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02586701     History of Changes
Other Study ID Numbers: MM123
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases