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AzTrials

Colorectal CancerPhase 2NCT01356264

Multimodal Prehabilitation for Colorectal Surgery

A Phase 2 study testing multimodal prehabilitation in people with Colorectal Cancer and Colorectal Cancer Stage III, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
multimodal prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteCanada
Study dates
Jul 2011to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • referred for scheduled surgery for nonmetastasized colorectal cancer
  • age > 18 years old

Who cannot join

  • asa 4-5
  • Poor English or French comprehension
  • severe co-morbid disease interfering with ability to perform exercise at home or complete testing

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre

    Montreal, Quebec, H3G1A4

Other trials in Canada

About this study

Official title: Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.

Being tested
multimodal prehabilitation
Keywords
colorectal cancer, colorectal surgery, prehabilitation, surgical recovery, exercise, referred for scheduled resection
Medical subject headings
Colorectal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multimodal prehabilitationBehavioural

    multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks

  • multimodal prehabilitationBehavioural

    multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks

Study groups in NCT01356264
Study groupRoleWhat they receive
multimodal prehabilitation begun preopExperimentalThe prehabilitation program will begin several weeks preop and continue in the postoperative period
Receives: Behavioral: multimodal prehabilitation
Multimodal prehabilitation begun postopActive comparatorThe prehabilitation program will begin after the surgery.
Receives: Behavioral: multimodal prehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. six minute walk test

    6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.

    Measured: baseline, preop, 4 weeks, 8weeks postop

Secondary outcomes (6)

  1. Health-related quality of life

    The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available. It incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts.

    Measured: baseline, preop, 4 weeks, 8 weeks

  2. physical activity level

    Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities

    Measured: baseline, preop, 4 weeks, 8 weeks

  3. Depression and anxiety

    Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.

    Measured: baseline, preop, 4 weeks, 8 weeks

  4. nutritional status

    Nutritional status will be assessed at baseline by measuring body mass index (BMI), body weight loss over the preceding three months (> 10% ), and/or serum albumin < 35 g -1 will define poor nutritional status.

    Measured: baseline, preop, 4 weeks, 8 weeks

  5. postoperative complications

    Classified by Clavien Scale

    Measured: 4 weeks

  6. Fatigue

    Fatugue Index

    Measured: baseline, preop, 4 wks, 8 wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMar 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01356264
Sponsor's protocol ID
GEN# 11-004
Status last verified
Sep 2015
First submitted
17 May 2011
Last updated
29 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37162250

  • 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.

    PubMed 35588252

  • Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.

    PubMed 30025745

  • Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

    PubMed 23052535

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing multimodal prehabilitation in people with Colorectal Cancer and Colorectal Cancer Stage III, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

six minute walk test (time frame: baseline, preop, 4 weeks, 8weeks postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01356264, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015; AzTrials last refreshed its copy on 29 Oct 2026.

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