Mechanistic Prehabilitation

March 20, 2018 updated by: Franco Carli

Understanding How Exercise and Nutrition Enhance Preoperative Functional Capacity: a Mechanistic Study

The investigators hypothesize that individuals who receive a personalized 4 week prehabilitation program consisting of exercise and nutrition counselling with post-workout whey protein supplementation will show, before colorectal surgery, improved insulin sensitivity, inflammatory profile, and substrate utilization compared to baseline measures. These results will translate into a higher functional capacity before surgery as demonstrated by an improvement in 6-minute walking test.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Intervention Physical exercise program

At the baseline assessment all patients' physical fitness will be evaluated by the kinesiologist (exercise specialist). The exercise component will consist of approximately 60 min of resistance and aerobic training, for a minimum of 3 days per week. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard)50 and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 % of heart rate reserve, HRR), and 25 min of resistance training (8 exercises targeting major muscle groups performed at moderate intensity), and a 5-10 min cool-down and stretching period. All exercises will be clearly explained and demonstrated by the kinesiologist at baseline. Patients will be asked to carry out this program at home, unsupervised, but will be monitored with weekly telephone calls. Training intensity progression will occur when the participant can complete aerobic exercise on mild exertion and/or when the participant can complete 15 repetitions of a given resistance exercise. Participants will be provided with resistance bands and an exercise mat, as well as a pedometer and a heart rate monitor, which can be used by the participant to monitor progress and by the kinesiologist to monitor daily compliance. A log book will also be completed to report all activities and frequency of exercises completed.

The kinesiologist will follow (by telephone call) all the participants on a weekly basis to ensure program compliance and address any barriers that may prevent ongoing participation.

Nutritional counseling The patients' nutritional status and adequacy of dietary intake will be assessed by a nutritionist using a three day food record, biological indices (e.g. glycated hemoglobin), clinical history, and the Patient-Generated Subjective Global Assessment tool51. Anthropometric measures, including percentage of lean body mass and fat, will be measured with bioelectrical impedance and skin calipers. Nutritional care plans will focus on meeting daily protein requirements (1.2g/kg), management of cancer-related symptoms (such as diarrhea, constipation), blood glucose control, optimization of body composition (i.e. weight loss/gain if necessary) and nutrient intake through providing practical suggestions, based on actual intake, to improve macronutrient distributions of protein, fat, and carbohydrates.

The type of dietary protein (amino acid composition), digestibility, amount, timing of intake, and co-ingestion with other macronutrients can be used to capitalize on post-exercise induced muscle protein synthesis52. Twenty (20) grams of protein, in liquid form, taken immediately after resistance exercise is regarded as sufficient to maximally stimulate muscle protein synthesis in healthy individuals52. Whey protein, in particular, is regarded as being especially effective when ingested after exercise54 because it is rapidly digested and contains all of the indispensable amino acids including leucine, which is believed to independently stimulate translation initiation of protein synthesis in skeletal muscle52. Post exercise co-ingestion with carbohydrate does not appear to provide any further anabolic effect, although does improve protein balance by blunting proteolysis and maximally stimulating insulin secretion55.

The nutritionist will provide patients with a post-workout nutrition prescription consisting of 20g of whey protein52 and 1g/kg carbohydrates53. Elderly patients require at least a 20g dose of dietary protein after resistance exercise and approximately 30g doses, in intervals, within the 24h "window of anabolic opportunity" in order to simulate an anabolic response 52.54,61. Ingestion of 1-1.5g carbohydrate/kg, within the "glycogen recovery window" of 15-30 minutes after exercise, replenishes glycogen stores53.

To ensure compliance, patients will be asked to complete daily logs and to return their empty sachets of whey protein.

Relaxation Strategies The kinesiologists will instruct patients to perform deep breathing exercises for relaxation purposes. Patients will be instructed to perform these exercises daily and as needed. Relaxation CD's, including soothing sounds, will also be given to patients.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective colorectal surgery for cancer
  • 65 years and older

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) health status class 4-5
  • disabling co-morbid physical and mental conditions (e.g. orthopedic and neuromuscular disease, dementia, psychosis)
  • endocrine disorders (diabetes or hemoglobin A1C>6, hyper and hypothyrodisim)
  • steroid consumption
  • cardiac failure (New York Heart Association classes I-IV)
  • chronic obstructive pulmonary disease
  • renal failure (creatinine > 115µmol/l)
  • hepatic failure (liver aminotranferases >50% the normal range)
  • morbid obesity (BMI >40)
  • anemia (hematocrit < 30 %, haemoglobin <100 g/L, albumin < 25 g/L)
  • poor comprehension of English or French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prehabilitation
All patients will receive a prehabilitation program involving an individualized exercise and nutrition program 4 weeks before surgery. Whole body protein kinetics and insulin resistance will be determined at the beginning of the program and at the end of the program.
Other: Prehabilitation
All patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist.
Device: hyperinsulinemic euglycemic isoaminoacid clamp
A hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics.
Device: hyperinsulinemic euglycemic hyperaminoacid clamp
Dietary supplement: whey protein supplementation
Other: Prehabilitation
All patients will receive nutrition guidance and a nutrition component with whey protein supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein Synthesis
Time Frame: up to 4 weeks before surgery
The change in whole body protein synthesis, measured using stable isotope technology, from baseline to date of surgery, will be documented, in response to hyperinsulinemia with the use of a hyperinsulinemic euglycemic hyperaminoacidemic clamp.
up to 4 weeks before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franco Carli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-127-GEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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