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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356264
Other study ID # GEN# 11-004
Secondary ID
Status Completed
Phase Phase 2
First received May 17, 2011
Last updated September 26, 2015
Start date July 2011
Est. completion date December 2013

Study information

Verified date September 2015
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 100 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
multimodal prehabilitation
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
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks

Locations

Country Name City State
Canada McGill University Health Centre Montreal Quebec

Sponsors (3)

Lead Sponsor Collaborator
McGill University Health Center Immunotec Inc., Society of American Gastrointestinal and Endoscopic Surgeons

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary postoperative complications Classified by Clavien Scale 4 weeks Yes
Secondary Fatigue Fatugue Index baseline, preop, 4 wks, 8 wks No
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