Recruiting

Pre-habilitation

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT01542281

Conditions

Colorectal Neoplasm

Biliary Tract Neoplasm

Liver Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Whey protein and dietary supplements

prehab exercise

Study Details

Brief summary:

1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
2. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Conditions

Colorectal Neoplasm

Biliary Tract Neoplasm

Liver Neoplasm

Study ID

NCT01542281

Start date

Jan, 2012

Status verified date

Feb, 2012

Completion date

Jan, 2015

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.

Exclusion Criteria:

  • Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
  • Patients will be excluded if they have poor English or French comprehension.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nutritional supplementation and prehab

The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program.

active comparator: Prehab exercise

Interventions

Whey protein and dietary supplements

Whey protein and dietary supplements in addition to pre-hab exercise

prehab exercise

minimum 4 weeks and maximum 8 weeks; 3 times a week

Primary outcome measure

  • Change in six minute walk test [ Time Frame: 8 weeks pre-op and 1 week pre-op ]

Central Contacts and Locations

Central contacts

Ayat Salman, MSccandidate

5149341934ayat.salman@muhc.mcgill.ca

Locations

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H3A1A1

Contacts

Ayat Salman, MSccandidate

5149341934ayat.salman@muhc.mcgill.ca

Principal Investigator:

Prosanto Chaudhury, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 2, 2012

Last verified

Feb, 2012

Keywords

  • liver resection
  • hepatectomy
  • pre-habilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2012-03-02.