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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02502760
Enrollment
120
Registered
2015-07-20
Start date
2015-08-31
Completion date
2019-06-19
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly

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.

Interventions

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

DIETARY_SUPPLEMENTWhey Protein Isolate Powder

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

Relaxation techniques consisting of breathing exercises and using a relaxation CD.

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital
CollaboratorOTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Post operative complications30 days after surgeryComprehensive Complication Index (CCI)

Secondary

MeasureTime frameDescription
6 Minutes Walk Test Distance4 weeks after discharge
Hospital Length of Stay3-6 days
Anxiety and Depression30 days after dischargeUsing the Hospital Anxiety Depression Scale (HADS)
Health Related Quality of Life30 days after dischargeUsing the Short Form Health Survey (SF-36)
Readmission rates30 days after discharge

Other

MeasureTime frameDescription
Cost Effectiveness of treatment30 days after hospital dischargeFactoring the cost of the program versus possible savings related to other primary and secondary outcomes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026