Multimodal Prehabilitation for Colorectal Surgery

• ClinicalTrials.gov Identifier: NCT01356264
• Recruitment Status: Completed
• First Posted: May 19, 2011
• Last Update Posted: September 29, 2015
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Society of American Gastrointestinal and Endoscopic Surgeons; Immunotec Inc.
• Information provided by (Responsible Party): Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description

Brief Summary:

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Colorectal Cancer Stage III	Behavioral: multimodal prehabilitation	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial
• Study Start Date: July 2011
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: multimodal prehabilitation begun preop; The prehabilitation program will begin several weeks preop and continue in the postoperative period	Behavioral: multimodal prehabilitation; multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks
Active Comparator: Multimodal prehabilitation begun postop; The prehabilitation program will begin after the surgery.	Behavioral: multimodal prehabilitation; multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks

Outcome Measures

Primary Outcome Measures :

1. six minute walk test [ Time Frame: baseline, preop, 4 weeks, 8weeks postop ]
   6 MWT is a patient-relevant measure of functional walking capacity, 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. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.

Secondary Outcome Measures :

1. Health-related quality of life [ Time Frame: baseline, preop, 4 weeks, 8 weeks ]
   The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available. It incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts.
2. physical activity level [ Time Frame: baseline, preop, 4 weeks, 8 weeks ]
   Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities
3. Depression and anxiety [ Time Frame: baseline, preop, 4 weeks, 8 weeks ]
   Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.
4. nutritional status [ Time Frame: baseline, preop, 4 weeks, 8 weeks ]
   Nutritional status will be assessed at baseline by measuring body mass index (BMI), body weight loss over the preceding three months (> 10% ), and/or serum albumin < 35 g -1 will define poor nutritional status.
5. postoperative complications [ Time Frame: 4 weeks ]
   Classified by Clavien Scale
6. Fatigue [ Time Frame: baseline, preop, 4 wks, 8 wks ]
   Fatugue Index

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• referred for scheduled surgery for nonmetastasized colorectal cancer
• age > 18 years old

Exclusion Criteria:

• asa 4-5
• Poor English or French comprehension
• severe co-morbid disease interfering with ability to perform exercise at home or complete testing

Contacts and Locations

Locations

Canada, Quebec

McGill University Health Centre

Montreal, Quebec, Canada, H3G1A4

Sponsors and Collaborators

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

Society of American Gastrointestinal and Endoscopic Surgeons

Immunotec Inc.

More Information

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.

Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

• Responsible Party: Dr. Liane S. Feldman, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
• ClinicalTrials.gov Identifier: NCT01356264 History of Changes
• Other Study ID Numbers: GEN# 11-004
• First Posted: May 19, 2011
• Last Update Posted: September 29, 2015
• Last Verified: September 2015

Keywords provided by Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre:

colorectal cancer; colorectal surgery; prehabilitation; surgical recovery; exercise; referred for scheduled resection

Additional relevant MeSH terms:

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