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

NCT02586701 | Completed

• 1 other identifier: MM123
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prehabilitation Plus

ACTIVE COMPARATOR

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

Rehabilitation

NO INTERVENTION

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.

Interventions

Prehabilitation Plus OTHER

Supervised exercise program and home-based exercise program.

Prehabilitation Plus

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred electively for resection of malignant, non metastasized, colorectal lesions.
• French or English speaking

You may not qualify if:

• 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).

Sponsors & Collaborators

• Franco Carli: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (5)

• 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.

  PMID: 25076007 BACKGROUND

• 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.

  PMID: 21878237 BACKGROUND

• 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. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

  PMID: 37162250 DERIVED

• 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.

  PMID: 35588252 DERIVED

• 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.

  PMID: 30025745 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Francesco Carli, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Study Start: September 1, 2013
• Primary Completion: December 20, 2016
• Study Completion: December 31, 2016
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

CA (1)