Multimodal Prehabilitation for Colorectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by McGill University Health Center
Sponsor:
Collaborators:
Society of American Gastrointestinal and Endoscopic Surgeons
Immunotec Inc.
Information provided by (Responsible Party):
Dr. Liane S. Feldman, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01356264
First received: May 17, 2011
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Colorectal Cancer
Colorectal Cancer Stage III
Behavioral: multimodal prehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • six minute walk test [ Time Frame: baseline, preop, 4 weeks, 8weeks postop ] [ Designated as safety issue: No ]
    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:
  • Health-related quality of life [ Time Frame: baseline, preop, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    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.

  • physical activity level [ Time Frame: baseline, preop, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    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

  • Depression and anxiety [ Time Frame: baseline, preop, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    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.

  • nutritional status [ Time Frame: baseline, preop, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
    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.

  • postoperative complications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Classified by Clavien Scale

  • Fatigue [ Time Frame: baseline, preop, 4 wks, 8 wks ] [ Designated as safety issue: No ]
    Fatugue Index


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356264

Contacts
Contact: Franco Carli, MD 514 934 1934 franco.carli@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G1A4
Principal Investigator: Franco Carli, MD         
Sub-Investigator: Liane Feldman, MD         
Sub-Investigator: Ann Gamsa, PhD         
Sub-Investigator: Sender Liberman, MD         
Sub-Investigator: Barry Stein, MD         
Sub-Investigator: Patrick Charlebois, MD         
Sponsors and Collaborators
McGill University Health Center
Society of American Gastrointestinal and Endoscopic Surgeons
Immunotec Inc.
  More Information

No publications provided

Responsible Party: Dr. Liane S. Feldman, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01356264     History of Changes
Other Study ID Numbers: GEN# 11-004
Study First Received: May 17, 2011
Last Updated: November 22, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014