Back to resultsSupervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation Plus
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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)
- Sepsis
- Morbid obesity (BMI > 40)
- Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).
Sites / Locations
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Prehabilitation Plus
Rehabilitation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Six Minute Walk Test (6MWT)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02586701
Brief Title
Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
Official Title
Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Franco Carli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation Plus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rehabilitation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prehabilitation Plus
Intervention Description
Supervised exercise program and home-based exercise program.
Primary Outcome Measure Information:
Title
Six Minute Walk Test (6MWT)
Description
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.
Time Frame
up to 8 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Sepsis
Morbid obesity (BMI > 40)
Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Carli, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25076007
Citation
Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
Results Reference
background
PubMed Identifier
21878237
Citation
Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
Results Reference
background
PubMed Identifier
35588252
Citation
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
Results Reference
derived
PubMed Identifier
30025745
Citation
Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
Results Reference
derived
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Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
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