Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Behavioral: Physical Exercise Program
* Dietary Supplement: Whey Protein Isolate Powder
* Behavioral: Relaxation Techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colorectal cancer patient undergoing resection Frail or intermediately frail patients (Fried score 2 and above) Exclusion Criteria: Unable to communicate in French or English Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>Immediately after randomization and until surgery, patients in this arm will: - Receive a personalized physical exercise program - Receive nutritional counselling with Whey protein isolate powder - Receive relaxation techniques | Behavioral: Physical Exercise Program<br>* Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.<br>Dietary Supplement: Whey Protein Isolate Powder<br>* Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided. Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses<br>Behavioral: Relaxation Techniques<br>* Relaxation techniques consisting of breathing exercises and using a relaxation CD.<br>|
| Active Comparator: Rehabilitation<br>Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery. | Behavioral: Physical Exercise Program<br>* Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.<br>Dietary Supplement: Whey Protein Isolate Powder<br>* Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided. Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses<br>Behavioral: Relaxation Techniques<br>* Relaxation techniques consisting of breathing exercises and using a relaxation CD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complications | Comprehensive Complication Index (CCI) | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walk Test Distance |  | 4 weeks after discharge | 
| Hospital Length of Stay |  | 3-6 days | 
| Readmission rates |  | 30 days after discharge | 
| Anxiety and Depression | Using the Hospital Anxiety Depression Scale (HADS) | 30 days after discharge | 
| Health Related Quality of Life | Using the Short Form Health Survey (SF-36) | 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly