Skip to main content
Clinical Trials/NCT01356264
NCT01356264
Completed
Phase 2

Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country89 target enrollmentJuly 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
89
Locations
1
Primary Endpoint
six minute walk test
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Dr. Liane S. Feldman

MD

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Health-related quality of life(baseline, preop, 4 weeks, 8 weeks)
  • physical activity level(baseline, preop, 4 weeks, 8 weeks)
  • Depression and anxiety(baseline, preop, 4 weeks, 8 weeks)
  • nutritional status(baseline, preop, 4 weeks, 8 weeks)
  • postoperative complications(4 weeks)
  • Fatigue(baseline, preop, 4 wks, 8 wks)

Study Sites (1)

Loading locations...

Similar Trials