Multimodal Prehabilitation for Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356264
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : September 29, 2015
Society of American Gastrointestinal and Endoscopic Surgeons
Immunotec Inc.
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center

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 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

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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356264

Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Society of American Gastrointestinal and Endoscopic Surgeons
Immunotec Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Liane S. Feldman, MD, McGill University Health Center Identifier: NCT01356264     History of Changes
Other Study ID Numbers: GEN# 11-004
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Dr. Liane S. Feldman, McGill University Health Center:
colorectal cancer
colorectal surgery
surgical recovery
referred for scheduled resection

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases