Multimodal Prehabilitation for Colorectal Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Colorectal Cancer Stage III

Intervention / Treatment
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* Behavioral: multimodal prehabilitation
* Behavioral: multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multimodal prehabilitation begun preop<br>The prehabilitation program will begin several weeks preop and continue in the postoperative period | Behavioral: multimodal prehabilitation<br>* 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<br>|
| Active Comparator: Multimodal prehabilitation begun postop<br>The prehabilitation program will begin after the surgery. | Behavioral: multimodal prehabilitation<br>* multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minute walk test | 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 | 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 | 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 | 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 | 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 | Classified by Clavien Scale | 4 weeks | 
| Fatigue | Fatugue Index | baseline, preop, 4 wks, 8 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, colorectal surgery, surgical recovery, exercise, referred for scheduled resection, prehabilitation