Multimodal Prehabilitation for Colorectal Surgery
- Conditions
- Colorectal Cancer Stage IIIColorectal Cancer
- Interventions
- Behavioral: multimodal prehabilitation
- Registration Number
- NCT01356264
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
- referred for scheduled surgery for nonmetastasized colorectal cancer
- age > 18 years old
- asa 4-5
- Poor English or French comprehension
- severe co-morbid disease interfering with ability to perform exercise at home or complete testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description multimodal prehabilitation begun preop multimodal prehabilitation The prehabilitation program will begin several weeks preop and continue in the postoperative period Multimodal prehabilitation begun postop multimodal prehabilitation The prehabilitation program will begin after the surgery.
- Primary Outcome Measures
Name Time Method six minute walk test 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 Outcome Measures
Name Time Method Health-related quality of life 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.
physical activity level 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
Depression and anxiety 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.
nutritional status 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.
postoperative complications 4 weeks Classified by Clavien Scale
Fatigue baseline, preop, 4 wks, 8 wks Fatugue Index
Trial Locations
- Locations (1)
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada