Multimodal Prehabilitation for Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT01356264|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : September 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Cancer Stage III||Behavioral: multimodal prehabilitation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||December 2013|
Experimental: multimodal prehabilitation begun preop
The prehabilitation program will begin several weeks preop and continue in the postoperative period
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
Active Comparator: Multimodal prehabilitation begun postop
The prehabilitation program will begin after the surgery.
Behavioral: multimodal prehabilitation
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks
- 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.
- 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.
- 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
- 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.
- 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.
- postoperative complications [ Time Frame: 4 weeks ]Classified by Clavien Scale
- Fatigue [ Time Frame: baseline, preop, 4 wks, 8 wks ]Fatugue Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356264
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3G1A4|