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Trial record 52 of 318 for:    colon cancer | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 26, 2015
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02586701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
Official Title  ICMJE Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Other: Prehabilitation Plus
Supervised exercise program and home-based exercise program.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Prehabilitation Plus
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
134
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)
50
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02586701
Other Study ID Numbers  ICMJE MM123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE Franco Carli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Francesco Carli, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP