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

• ClinicalTrials.gov Identifier: NCT02586701
• Recruitment Status: Completed
• First Posted: October 26, 2015
• Last Update Posted: March 22, 2018
• Sponsor: Franco Carli
• Information provided by (Responsible Party): Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Locations

Canada, Quebec

Montreal General Hospital

Montreal, Quebec, Canada, H3A 1A1

Sponsors and Collaborators

Franco Carli

Investigators

• Study Chair: Francesco Carli, MD; McGill University Health Centre/Research Institute of the McGill University Health Centre

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SÈ, 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.

• Responsible Party: Franco Carli, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
• ClinicalTrials.gov Identifier: NCT02586701
• Other Study ID Numbers: MM123
• First Posted: October 26, 2015
• Last Update Posted: March 22, 2018
• Last Verified: March 2018

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases