Know Cancer

forgot password

Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.

Phase 2
18 Years
Not Enrolling
Colorectal Surgery

Thank you

Trial Information

Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.

The surgical process is a major stressor because of the psychological distress, tissue
trauma, lack of activity, and quasi-starvation and it produces immediate systemic changes
and both short- and long-term effects on activity and quality of life. However, there is
mounting evidence that many of the negative immediate effects of surgery such as pain,
fatigue, and weakness are amenable to intervention. If proper interventions are carried
out, these symptoms may be readily controlled allowing for a faster recovery and early home
discharge. But the effects of surgery are felt far beyond the immediate convalescent period
and patients can feel fatigued for many weeks and this delays return to usual function and
reduces quality of life. Thus, it would be of great practical benefit if ways of improving
post-surgery physical function and quality of life could be identified.

Traditionally efforts have been made to improve the recovery process by intervening in the
post-operative period. However, the post-operative period may not be the most opportune
time to introduce interventions to accelerate recovery. Many of these surgical patients are
concerned about perturbing the healing process as well as being depressed and anxious if
they await further treatment. The pre-operative period may be a more emotionally salient
time to intervene in the factors that contribute to recovery. The process of enhancing
functional capacity of the individual to enable him or her to withstand an incoming stressor
has been termed prehabilitation The purpose of this study is to address the following
research question: Among persons scheduled for colorectal surgery, does a pre-operative
program of aerobic and muscle strength training (prehabilitation) compared to a standard
peri-operative educational protocol affect functional exercise capacity and health-related
quality of life? The trial will be a single blind, stratified (on cancer diagnosis or not),
randomized, two-group (prehabilitation or standard care), parallel design. Both groups will
receive the same peri-operative education program. In conformity with current practice, all
subjects will also be advised on nutritional support during the preoperative period.
Persons with albumin < 38 gm./l will receive an adequate supply of protein and calorie
nutritional supplement bars. In addition to this standard care, the prehabilitation group
will be prescribed a program of exercise training consisting of daily stationary cycling
from the start of the intervention to the day prior to surgery (minimum 3 weeks) combined
with an individualized program of muscle strength training.

Both groups will be evaluated for exercise tolerance, walking capacity and health and
emotional status at enrolment and after 3 three weeks of training as well as at 4 weeks, 8
weeks and 24 weeks (6 months) post-surgery. The main outcome measure will be the 6 Minute
Walk Test - a valid and reliable measure of functional walking capacity. The estimator of
effect will be the proportion of people in each group who, at 8 weeks post-surgery, achieve
or exceed their baseline value on this test (± 20m). The proposed sample size is 200. This
is based on 80% power to detect a difference of 22% in the proportion recovering to baseline
values (40% in standard and 62% in prehabilitation). The results of this trial will be used
to inform practitioners and patients alike of the benefits (or risks if any) of exercise in
preparing for surgery.

Inclusion Criteria:

- Age 18 and above

- Referred electively for colorectal resection for benign (polyposis adenoma
diverticulitis) or non-disseminated colon and rectum cancers

- Referred electively for colorectal resection for colon reconstruction for non-active
inflammatory bowel disease

- Referred electively for colorectal resection for fibrostenotic conditions that are a
feature of Crohn's disease.

Exclusion Criteria:

- People with American Society of Anesthesiologists health status class 4-5

- Co-morbid medical conditions interfering with the ability to participate in either
group or complete the testing procedures (e.g. dementia, disabling orthopedic and
neuromuscular disease, psychosis)

- Patients at high risk for a cardiac complication during exercise at home: severe
aortic stenosis, cardiac failure Class IV NYHA, myocardial infarction within 6
months, congestive heart failure, and unstable angina

- Persons with sepsis; and treatment with chemotherapy or radiotherapy during six
months prior to the date of surgery

- Those with very low exercise tolerance (<3.5 METS) as determined by the baseline
exercise test

- Anyone with a cardiac arrhythmia that manifests during the baseline exercise testing,
prior to randomization

- Those people who are already in excellent physical condition owing to a regular
participation in a high intensity physical activity. On testing, persons whose
age-predicted value on the 6MWT exceeds 130% will be excluded (expected <10%)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

6 Minute Walk Test

Outcome Time Frame:

baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks

Safety Issue:


Principal Investigator

Francesco Carli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Health Center


Canada: Ethics Review Committee

Study ID:




Start Date:

February 2005

Completion Date:

December 2008

Related Keywords:

  • Colorectal Surgery
  • Colon
  • Surgery
  • Prehabilitation
  • Exercise