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

Colorectal Cancer Clinical Trial

Official title:

Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586701
• Other study ID #: MM123
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: March 20, 2018
• Start date: September 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 31, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Prehabilitation Plus
Supervised exercise program and home-based exercise program.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Franco Carli

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 8 weeks after surgery