Multimodal Prehabilitation for Colorectal Surgery
Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G1A4
- McGill University Health Centre
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
- Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
- Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
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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