PrehabilitationNCT04247776
Pragmatic Prehabilitation for Colorectal Surgery
A study testing Prehab, ERAS and Fitbit in people with Prehabilitation and Colorectal Surgery, run by University of Calgary at 1 site in Canada.
Trial summary
Colorectal surgery is a common surgery for the treatment of colon and rectal cancers as well as other bowel diseases. Recovery from colorectal surgery is difficult because of the many potential negative side effects. These side effects include surgical complications, infections, and long hospital stays. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prehabilitation, Colorectal Surgery, Enhanced Recovery After Surgery
- What is being tested?
- Prehab, ERAS and Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 1 May 2021
- Phase
- Interventional
- 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
- 18 years of age or older;
- elective colorectal surgery for primary disease under ERAS care at PLC;
- have at least two weeks to participate before their scheduled surgery (i.e., surgery will NOT be rescheduled based on participation in this program);
- are able to walk;
- sufficient fluency in English to complete questionnaires.
Who cannot join
- emergent surgery;
- dairy allergy;
- galactosemia;
- strict vegans;
- presence of a condition that could compromise the safety of the patient or adherence to the program, including
- Co-morbid medical, physical, and/or mental conditions including dementia, disabling orthopedic and neuromuscular disease, psychosis;
- Severe cardiopulmonary abnormalities, sepsis, and end-stage organ disease: cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease, renal failure (creatinine > 115µmol/l), hepatic failure (liver aminotranferases >50% the normal range).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prehabilitation for Colorectal Surgery: A Pragmatic Effectiveness-Implementation Randomized Controlled Trial
Colorectal surgery is a common surgery for the treatment of colon and rectal cancers as well as other bowel diseases. Recovery from colorectal surgery is difficult because of the many potential negative side effects. These side effects include surgical complications, infections, and long hospital stays. It usually takes several months for patients to recover the strength required to return to their typical daily activities.
The Enhanced Recovery After Surgery program was established in Alberta in 2013 and uses several strategies to improve short-term patient recovery, including earlier discharge from hospital. Whether the ERAS program also improves long-term patient recovery, including quality of life and return to activities of daily living, is unclear. Whether the ERAS program would benefit from the addition of a prehabilitation element is unclear.
Read more
Prehabilitation programs are designed to use the waiting period before colorectal surgery to better prepare patients emotionally and physically for their operation. To date, successful prehabilitation programs have used a personalized care strategy where each patient is provided specific care instructions by healthcare professionals to meet their unique exercise, nutrition, and psychological needs. This prehabilitation strategy has been criticized for not being sustainable in our healthcare system.
A new prehabilitation program in response to this criticism is proposed. The prehabilitation program will be conducted in a more sustainable way by offering the program as a group class with a home-based component. ERAS patients at the Peter Lougheed Center are already offered a group class as part of the standard ERAS program. The prehabilitation class will be an extension of this group class that provides general nutrition, exercise, and anxiety-reduction/relaxation strategies to help patients prepare physically and emotionally for their operation. At this class, patients will learn to eat well, practice deep breathing exercises for relaxation, perform simple functional exercises, and to walk for exercise before their surgery. The surgical experience and outcomes of patients who received the additional prehabilitation care will be compared to those who received ERAS care only.
The overall goal of the study is to better understand how ERAS supports recovery after surgery and whether a prehabilitation program offers any additional benefits to the ERAS program currently in place.
- Being tested
- Prehab, ERAS, Fitbit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabCombination product
Exercise: functional exercises, walking, Fitbit goals Nutrition: handout, supplements (protein, vitamins, minerals) Stress reduction: deep breathing
ERASOther
Enhanced Recovery After Surgery guidelines are applied.
FitbitBehavioural
Fitbit is worn to monitor step counts.
| Study group | Role | What they receive |
|---|---|---|
| Prehab | Experimental | General nutrition, relaxation, and exercise instructions. Home-based functional exercises, Fitbit goals, and nutrition supplements. Receives: Combination Product: Prehab; Other: ERAS; Behavioral: Fitbit |
| ERAS | Active comparator | Enhanced Recovery After Surgery standard of care plus Fitbit. Receives: Other: ERAS; Behavioral: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS)
Length of hospital stay
Measured: from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgery
Secondary outcomes (1)
Complications
Any complication within 30 days of surgery
Measured: from date of surgery until 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Dec 2018
- Primary completion1 Sep 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic RCT Effectiveness- Implementation Hybrid
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsia Gillis, University of Calgary
- Investigators
- Chelsia Gillis, PhD(c), Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247776
- Sponsor's protocol ID
- REB18-0979
- Status last verified
- May 2021
- First submitted
- 23 Jan 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
PubMed 25076007Gillis 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 30025745Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8.
PubMed 29750973Gillis C, Hasil L, Keane C, Brassard D, Kiernan F, Bellafronte NT, Culos-Reed SN, Gramlich L, Ljungqvist O, Fenton TR. A multimodal prehabilitation class for Enhanced Recovery After Surgery: a pragmatic randomised type 1 hybrid effectiveness-implementation trial. Br J Anaesth. 2026 Apr;136(4):1166-1178. doi: 10.1016/j.bja.2025.03.001. Epub 2025 Apr 7.
PubMed 40199628
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation for Colorectal Surgery: A Pragmatic Effectiveness-Implementation Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04247776
- Acronym / sponsor ID
- REB18-0979
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal surgery is a common surgery for the treatment of colon and rectal cancers as well as other bowel diseases. Recovery from colorectal surgery is difficult because of the many potential negative side effects. These side effects include surgical complications, infections, and long hospital stays. It usually takes several months for patients to recover the strength required to return to their typical daily activities.
The Enhanced Recovery After Surgery program was established in Alberta in 2013 and uses several strategies to improve short-term patient recovery, including earlier discharge from hospital. Whether the ERAS program also improves long-term patient recovery, including quality of life and return to activities of daily living, is unclear. Whether the ERAS program would benefit from the addition of a prehabilitation element is unclear.
Prehabilitation programs are designed to use the waiting period before colorectal surgery to better prepare patients emotionally and physically for their operation. To date, successful prehabilitation programs have used a personalized care strategy where each patient is provided specific care instructions by healthcare professionals to meet their unique exercise, nutrition, and psychological needs. This prehabilitation strategy has been criticized for not being sustainable in our healthcare system.
A new prehabilitation program in response to this criticism is proposed. The prehabilitation program will be conducted in a more sustainable way by offering the program as a group class with a home-based component. ERAS patients at the Peter Lougheed Center are already offered a group class as part of the standard ERAS program. The prehabilitation class will be an extension of this group class that provides general nutrition, exercise, and anxiety-reduction/relaxation strategies to help patients prepare physically and emotionally for their operation. At this class, patients will learn to eat well, practice deep breathing exercises for relaxation, perform simple functional exercises, and to walk for exercise before their surgery. The surgical experience and outcomes of patients who received the additional prehabilitation care will be compared to those who received ERAS care only.
The overall goal of the study is to better understand how ERAS supports recovery after surgery and whether a prehabilitation program offers any additional benefits to the ERAS program currently in place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic RCT Effectiveness- Implementation Hybrid
| Arm | Type | Receives |
|---|---|---|
| Prehab | Experimental | Combination Product: Prehab, Other: ERAS, Behavioral: FitbitGeneral nutrition, relaxation, and exercise instructions. Home-based functional exercises, Fitbit goals, and nutrition supplements. |
| ERAS | Active comparator | Other: ERAS, Behavioral: FitbitEnhanced Recovery After Surgery standard of care plus Fitbit. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older;
- elective colorectal surgery for primary disease under ERAS care at PLC;
- have at least two weeks to participate before their scheduled surgery (i.e., surgery will NOT be rescheduled based on participation in this program);
- are able to walk;
- sufficient fluency in English to complete questionnaires.
Key exclusion criteria (7 listed)
- emergent surgery;
- dairy allergy;
- galactosemia;
- strict vegans;
- presence of a condition that could compromise the safety of the patient or adherence to the program, including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabExercise: functional exercises, walking, Fitbit goals Nutrition: handout, supplements (protein, vitamins, minerals) Stress reduction: deep breathing | Combination product | Prehab |
| ERASEnhanced Recovery After Surgery guidelines are applied. | Other | ERAS, Prehab |
| FitbitFitbit is worn to monitor step counts. | Behavioural | ERAS, Prehab |
Primary outcome
Length of stay (LOS)
Time frame: from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgery
Length of hospital stay
1 secondary outcome
Complications
Time frame: from date of surgery until 30 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 25076007Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
- Background: PubMed 30025745Gillis 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.
- Background: PubMed 29750973Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8.
- Derived from this study: PubMed 40199628Gillis C, Hasil L, Keane C, Brassard D, Kiernan F, Bellafronte NT, Culos-Reed SN, Gramlich L, Ljungqvist O, Fenton TR. A multimodal prehabilitation class for Enhanced Recovery After Surgery: a pragmatic randomised type 1 hybrid effectiveness-implementation trial. Br J Anaesth. 2026 Apr;136(4):1166-1178. doi: 10.1016/j.bja.2025.03.001. Epub 2025 Apr 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chelsia Gillis, PhD(c) principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehab, ERAS and Fitbit in people with Prehabilitation and Colorectal Surgery, run by University of Calgary 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 5 inclusion and 7 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 5 May 2021. 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.
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?
Length of stay (LOS) (time frame: from date of surgery until hospital discharge, recorded in days, and assessed up to 6 weeks post-surgery). 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 NCT04247776, 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 5 May 2021.