Multimodal Prehabilitation for Colorectal Surgery

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: multimodal prehabilitation begun preop
The prehabilitation program will begin several weeks preop and continue in the postoperative period
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
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks
ACTIVE_COMPARATOR: Multimodal prehabilitation begun postop
The prehabilitation program will begin after the surgery.
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
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, preop, 4 weeks, 8weeks postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, preop, 4 weeks, 8 weeks
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
baseline, preop, 4 weeks, 8 weeks
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.
baseline, preop, 4 weeks, 8 weeks
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.
baseline, preop, 4 weeks, 8 weeks
postoperative complications
Time Frame: 4 weeks
Classified by Clavien Scale
4 weeks
Fatigue
Time Frame: baseline, preop, 4 wks, 8 wks
Fatugue Index
baseline, preop, 4 wks, 8 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (ESTIMATE)

May 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 26, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • GEN# 11-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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