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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Behavioral: Physical Exercise Program; Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Relaxation Techniques

• Registration Number: NCT02502760
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Study Start: 2015-08
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Relaxation Techniques	Immediately after randomization and until surgery, patients in this arm will: 1. - Receive a personalized physical exercise program 2. - Receive nutritional counselling with Whey protein isolate powder 3. - Receive relaxation techniques
Prehabilitation	Physical Exercise Program	Immediately after randomization and until surgery, patients in this arm will: 1. - Receive a personalized physical exercise program 2. - Receive nutritional counselling with Whey protein isolate powder 3. - Receive relaxation techniques
Rehabilitation	Physical Exercise Program	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.
Rehabilitation	Relaxation Techniques	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.
Prehabilitation	Whey Protein Isolate Powder	Immediately after randomization and until surgery, patients in this arm will: 1. - Receive a personalized physical exercise program 2. - Receive nutritional counselling with Whey protein isolate powder 3. - Receive relaxation techniques
Rehabilitation	Whey Protein Isolate Powder	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.

Primary Outcome Measures

Name	Time	Method
Post operative complications	30 days after surgery	Comprehensive Complication Index (CCI)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Sir Mortimer B. Davis - Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

McGill University Health Center; Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada