Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
NCT ID: NCT02502760
Last Updated: 2019-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
120 participants
INTERVENTIONAL
2015-08-31
2019-06-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enhancing Outcomes After Colon Surgery
NCT00227526
Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
NCT02586701
Prehabilitation in Frail Colon Cancer
NCT03097224
Multimodal Prehabilitation for Colorectal Surgery
NCT01356264
Prehabilitation in Colorectal Cancer
NCT03096951
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prehabilitation
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
Physical Exercise Program
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Whey 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
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
Rehabilitation
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.
Physical Exercise Program
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Whey 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
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physical Exercise Program
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Whey 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
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Frail or intermediately frail patients (Fried score 2 and above)
Exclusion Criteria
* Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Franco Carli
Professor, Montreal General Hospital Department of Anesthesia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Franco Carli, MD, MPhil
Role: PRINCIPAL_INVESTIGATOR
Professor, Department of Anesthesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McGill University Health Center; Montreal General Hospital
Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.
Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.
Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15-131-MUHC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.