Clinical trial NCT02586701: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 134
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: up to 8 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Francesco Carli, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.