Early Mobilization After Colorectal Surgery

March 2, 2018 updated by: Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre

Facilitation of Early Mobilization After Colorectal Surgery: A Randomized Controlled Trial

Early mobilization (i.e. initiation of out of bed activities from the day of surgery) is considered an important component of postoperative care after colorectal surgery. Having a health professional dedicated to facilitate early mobilization has the potential to enhance postoperative recovery by preventing the negative effects of prolonged bed rest (e.g. increased risk for complications, muscle loss, deconditioning and functional decline); however, the need to implement this resource-intensive approach is not evidence based. This study aims to contribute evidence about the role of facilitated early mobilization as a strategy to enhance recovery after colorectal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary research question of this study is: to what extent does postoperative facilitation of early mobilization impact on recovery of functional walking capacity at 4 weeks after surgery in comparison to standard care (preoperative education).

The hypothesis is that, by 4 weeks after surgery, facilitated early mobilization will result in a greater proportion of participants returning to preoperative levels of functional walking, as measured by the six-minute walk test (6MWT).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult people (>18 years)
  • Colonic or rectal diseases (i.e. cancer, inflammatory bowel disease, diverticulitis) planned for surgical resection

Exclusion Criteria:

  • Metastatic disease
  • Medical conditions that preclude postoperative mobilization (e.g. neurological or musculoskeletal diseases)
  • Inability to understand English or French
  • Admission to intensive care immediately after the surgery

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facilitated early mobilization
Early mobilization facilitated by a dedicated health professional
Other: Facilitated early mobilization
Participants randomized to this group, in addition the preoperative education (usual care), will have early mobilization facilitated by a trained health professional. This health professional will: (1) visit the participant on the day of surgery to reinforce mobilization goals and assist with transfer to a chair and (2) visit the participant three times per day starting from POD 1 to reinforce mobilization goals and walk with the participant (at least the length of the hallway). Targeted walking distances will increase according to the participant's tolerance. This intervention will be undertaken until POD 3 or hospital discharge, whichever comes first.
Other Names:
  • Early ambulation
Active Comparator: Usual care
Instructions about early mobilization covered in a preoperative education session
Other: Usual care
Participants randomized to this group will receive instructions about postoperative mobilization in a preoperative education session and will receive a booklet describing mobilization goals for each POD (sit in a chair for 2 hours on the day of surgery, stay out of bed for at least 6 hours/day from POD 1 until hospital discharge)
Other Names:
  • Preoperative education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional walking capacity (six-minute walk test)
Time Frame: before surgery; 4 weeks after surgery
The outcome of interest will be the proportion of participants returning to preoperative levels of functional walking capacity at 4 weeks after surgery (within an estimated measurement error of 20 meters)
before surgery; 4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time out of bed (sitting and standing)
Time Frame: postoperative day (POD) 0, 1, 2 and 3
Measured by an activity monitor (Actigraph) worn over the participants' hip
postoperative day (POD) 0, 1, 2 and 3
Time to readiness for discharge
Time Frame: duration of hospital stay (expected average of 3 days after surgery)
Time to achieve standardized hospital discharge criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self care and no evidence of complications or untreated medical problems).
duration of hospital stay (expected average of 3 days after surgery)
Time to recovery of gastrointestinal motility
Time Frame: Expected average of 2 days after surgery
Time to achieve criteria for recovery of gastrointestinal transit (tolerance of solid diet and bowel movement)
Expected average of 2 days after surgery
Postoperative fatigue (Multidimensional Fatigue Inventory)
Time Frame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.
before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery.
Self-reported physical activity status (Duke Activity Status Index)
Time Frame: before surgery; 2 weeks after surgery; 4 weeks after surgery
before surgery; 2 weeks after surgery; 4 weeks after surgery
Mobility (Life-Space Mobility Assessment)
Time Frame: before surgery; 4 weeks after surgery
before surgery; 4 weeks after surgery
Condition-specific health-related quality of life (Abdominal Surgery Impact Scale)
Time Frame: before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery
before surgery; POD 1, 2 and 3; 2 weeks after surgery; 4 weeks after surgery
Generic heath-related quality of life (RAND-36)
Time Frame: before surgery; 4 weeks after surgery
before surgery; 4 weeks after surgery
Postoperative complications
Time Frame: up to 4 weeks after surgery
Classified according to Clavien-Dindo Index and converted into a continuous scale using the Comprehensive Complication Index
up to 4 weeks after surgery
Pulmonary function (spirometry)
Time Frame: before surgery; POD 1, 2 and 3; 4 weeks after surgery
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and cough expiratory flow (CEF) will be recorded
before surgery; POD 1, 2 and 3; 4 weeks after surgery

Collaborators and Investigators

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

Sponsor

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

Collaborators

Mitacs

Investigators

  • Principal Investigator: Liane S Feldman, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Julio F Fiore Junior, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Nancy Mayo, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

General Publications

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

August 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

May 4, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHC Study Code 13-329-SDR
  • Mitacs Elevate Fellowship (Other Grant/Funding Number: IT02887)

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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