Abdominal Aortic AneurysmNCT05756283
The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair
A study testing Multimodal Prehabilitation in people with Abdominal Aortic Aneurysm, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Multimodal Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm. Participants should have the ability to give informed consent.
Who cannot join
- Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
- Participants with ruptured or symptomatic AAA.
- Participants with AAA maximal diameter ≥7cm.
- Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
- Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
- Cognitive impairment that would impede understanding of study procedures, informed consent or study questionnaires or the inability to effectively communicate in English/French/Spanish/Catalan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Amelie Lucaszewski, PhD contact
About this study
Official title: The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial
An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.
Read the detailed description
Abdominal aortic aneurysms (AAA) are asymptomatic until they rupture, which carries an 80- 90% mortality. Therefore, AAA are surgically repaired when they reach 5.0 cm in women and 5.5cm in men. Despite advances to surgical technique and peri-operative care, open surgical repair still carries a high incidence of post-operative complications of 30-40%, and a long recovery period. This is largely because the surgery itself is major abdominal surgery, and these patients often have significant comorbidities and low functional status. Multimodal prehabilitation (MP) is a concept that uses the preoperative timeframe (between diagnosis and surgery) to optimize physical, nutritional, and emotional wellbeing to improve a patient's functional status and ability to withstand the stress of surgery. To date, there is no study evaluating the effect of MP on post-operative complications following open AAA repair.
The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA repair compared to standard of care. This trial will also assess the effect of MP on functional capacity, hospital length of stay, 30-day mortality and health related quality of life, as well as to assess cost effectiveness, adherence, and fidelity to the intervention.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Multimodal Prehabilitation
- Keywords
- Prehabilitation, Exercise, Nutrition, Quality of life, Postoperative Complications, Psychosocial intervention
- Medical subject headings
- Aortic Aneurysm, Abdominal, Motor Activity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal PrehabilitationBehavioural
EXERCISE
- Supervised exercise
- High intensity interval training
- Strength exercise
- Home-based exercise / promotion of physical activity
- Low-moderate intensity aerobic training
- Inspiratory muscle training
- Low-moderate intensity strength training
NUTRITION: nutrition education and optimization. Intake of 0.4g/kg of whey isolate after every supervised training.
PSYCHOSOCIAL: mindfulness, cognitive reframing and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Prehabilitation | Experimental | Participants in the intervention group will undergo, in addition to the standard of care, 6+/-1 weeks of a personalized multimodal prehabilitation program. The interventions included will be patient-centered, aiming to optimize patients' preoperative health status while enhancing their empowerment and engagement. Receives: Behavioral: Multimodal Prehabilitation |
| Control group (standard of care) | No intervention | Participants in the control group will receive the standard of care. This will include comorbidity optimization, anemia correction and smoking cessation advice if deemed appropriate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications measured by the Comprehensive Complication Index (CCI)
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
Measured: CCI will be measured from admission to 6 weeks postoperatively
Secondary outcomes (27)
ICU Length of stay
Intensive Care Unit length of stay
Measured: From admission to 6 weeks postoperatively
Hospital length of stay
Days from admission to discharge from the hospital
Measured: From admission to 6 weeks postoperatively
Reinterventions
Need for surgical reintervention due to surgical complications
Measured: from surgery day to 6 week postoperatively
Readmission
Readmission to the hospital
Measured: at 6 weeks and at 1 year postoperatively
Emergency Room visits
Visits to the emergency room with or without admission to the hospital
Measured: at 6 weeks and at 1 year postoperatively
6-Minute Walk Test
6-minute walk test
Measured: Measured at baseline, preoperatively and 6 weeks postoperatively
VO2 peak
Oxygen consumption at peak exercise
Measured: Measured at baseline and preoperatively
VO2 AT
Oxygen consumption at anaerobic Threshold
Measured: Measured at baseline and preoperatively
VE/VCO2
Minute ventilation/carbon dioxide production
Measured: Measured at baseline and preoperatively
Yale physical activity survey (YPAS)
Questionnaire of daily physical activity
Measured: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
SF36
Quality of life questionnaire
Measured: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Depression
Depression measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no depression)- 21 (maximal depression)
Measured: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Anxiety
Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety)
Measured: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Patient Generated Subjective Global Assessment (PG-SGA)
Malnutrition assessment tool
Measured: Measured at baseline, preoperatively
Compliance to intervention
Compliance to the different components of the intervention, measured by attendance to supervised sessions (%), adherence to nutritional counseling and supplementation (%), adherence to home-based exercise (%) and adherence to the psychosocial sessions (%)
Measured: Measured from baseline to preoperatively
Fidelity to exercise intervention
Real training wattage and kg vs expected
Measured: Measured from baseline to preoperatively
Height
measurement of height in meters
Measured: Measured at baseline and preoperatively
Weight
measurement of Weight in kg
Measured: Measured at baseline and preoperatively
Body Mass Index (BMI)
Measurement of body mass index (weight and height will be combined to report BMI in kg/m^2)
Measured: Measured at baseline and preoperatively
Body Fat percentage
Measurement of body fat percentage using Bioelectrical Impedance Analysis
Measured: Measured at baseline and preoperatively
Fat Free Mass (FFM)
Measurement of body fa free mass in kg, using Bioelectrical Impedance Analysis
Measured: Measured at baseline and preoperatively
Muscle Mass
Measurement of muscle mass in kg, using Bioelectrical Impedance Analysis
Measured: Measured at baseline and preoperatively
Phase angle
Measurement of phase angle, using Bioelectrical Impedance Analysis
Measured: Measured at baseline and preoperatively
Satisfaction and acceptability
Intervention satisfaction and acceptability questionnaire
Measured: Preoperative assessment
Incidents of adverse events (prehabilitation safety and tolerability)
Incidence of adverse events and severe adverse events during prehabilitation program
Measured: Measured from Baseline to Preoperatively
Quality adjusted life years
Quality adjusted life years derived from SF36 data (SF6D)
Measured: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Prehabilitation cost-effectiveness
Measurement of prehabilitation cost-effectiveness using data from SF6D, prehabilitation costs and hospitalization related costs.
Measured: Measured at 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Heather Gill, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756283
- Sponsor's protocol ID
- PREHAAAB Trial
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):47-53. doi: 10.1097/SLA.0000000000001609.
PubMed 26756766Tew GA, Batterham AM, Colling K, Gray J, Kerr K, Kothmann E, Nawaz S, Weston M, Yates D, Danjoux G. Randomized feasibility trial of high-intensity interval training before elective abdominal aortic aneurysm repair. Br J Surg. 2017 Dec;104(13):1791-1801. doi: 10.1002/bjs.10669. Epub 2017 Oct 9.
PubMed 28990651Fenton C, Tan AR, Abaraogu UO, McCaslin JE. Prehabilitation exercise therapy before elective abdominal aortic aneurysm repair. Cochrane Database Syst Rev. 2021 Jul 8;7(7):CD013662. doi: 10.1002/14651858.CD013662.pub2.
PubMed 34236703Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902.
PubMed 30272585Coca-Martinez M, Doonan RJ, Gillis C, Mackenzie K, Obrand DI, Bayne JP, Steinmetz OK, Girsowicz E, Lopez-Baamonde M, Jessula S, Yugueros X, Martinez-Palli G, Gill HL. The PREHAAAB Trial: Multimodal prehabilitation for patients awaiting open abdominal aortic aneurysm repair - A study protocol for an international randomized controlled trial. PLoS One. 2025 Dec 29;20(12):e0339473. doi: 10.1371/journal.pone.0339473. eCollection 2025.
PubMed 41460856
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05756283
- Acronym / sponsor ID
- PREHAAAB Trial
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Prehabilitation, Exercise, Nutrition, Quality of life, Postoperative Complications, Psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Mar 2023 (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.
An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.
Detailed description
Abdominal aortic aneurysms (AAA) are asymptomatic until they rupture, which carries an 80- 90% mortality. Therefore, AAA are surgically repaired when they reach 5.0 cm in women and 5.5cm in men. Despite advances to surgical technique and peri-operative care, open surgical repair still carries a high incidence of post-operative complications of 30-40%, and a long recovery period. This is largely because the surgery itself is major abdominal surgery, and these patients often have significant comorbidities and low functional status. Multimodal prehabilitation (MP) is a concept that uses the preoperative timeframe (between diagnosis and surgery) to optimize physical, nutritional, and emotional wellbeing to improve a patient's functional status and ability to withstand the stress of surgery. To date, there is no study evaluating the effect of MP on post-operative complications following open AAA repair.
The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA repair compared to standard of care. This trial will also assess the effect of MP on functional capacity, hospital length of stay, 30-day mortality and health related quality of life, as well as to assess cost effectiveness, adherence, and fidelity to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Prehabilitation | Experimental | Behavioral: Multimodal PrehabilitationParticipants in the intervention group will undergo, in addition to the standard of care, 6+/-1 weeks of a personalized multimodal prehabilitation program. The interventions included will be patient-centered, aiming to optimize patients' preoperative health status while enhancing their empowerment and engagement. |
| Control group (standard of care) | No intervention | –Participants in the control group will receive the standard of care. This will include comorbidity optimization, anemia correction and smoking cessation advice if deemed appropriate. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm. Participants should have the ability to give informed consent.
Key exclusion criteria (6 listed)
- Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
- Participants with ruptured or symptomatic AAA.
- Participants with AAA maximal diameter ≥7cm.
- Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
- Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
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 |
|---|---|---|
| Multimodal PrehabilitationEXERCISE * Supervised exercise * High intensity interval training * Strength exercise * Home-based exercise / promotion of physical activity * Low-moderate intensity aerobic training * Inspiratory muscle training * Low-moderate intensity strength training NUTRITION: nutrition education and optimization. Intake of 0.4g/kg of whey isolate after every supervised training. PSYCHOSOCIAL: mindfulness, cognitive reframing and coping strategies. | Behavioural | Multimodal Prehabilitation |
Primary outcome
Postoperative complications measured by the Comprehensive Complication Index (CCI)
Time frame: CCI will be measured from admission to 6 weeks postoperatively
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
27 secondary outcomes
ICU Length of stay
Time frame: From admission to 6 weeks postoperatively
Hospital length of stay
Time frame: From admission to 6 weeks postoperatively
Reinterventions
Time frame: from surgery day to 6 week postoperatively
Readmission
Time frame: at 6 weeks and at 1 year postoperatively
Emergency Room visits
Time frame: at 6 weeks and at 1 year postoperatively
6-Minute Walk Test
Time frame: Measured at baseline, preoperatively and 6 weeks postoperatively
VO2 peak
Time frame: Measured at baseline and preoperatively
VO2 AT
Time frame: Measured at baseline and preoperatively
VE/VCO2
Time frame: Measured at baseline and preoperatively
Yale physical activity survey (YPAS)
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
SF36
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Depression
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Anxiety
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Patient Generated Subjective Global Assessment (PG-SGA)
Time frame: Measured at baseline, preoperatively
Compliance to intervention
Time frame: Measured from baseline to preoperatively
Fidelity to exercise intervention
Time frame: Measured from baseline to preoperatively
Height
Time frame: Measured at baseline and preoperatively
Weight
Time frame: Measured at baseline and preoperatively
Body Mass Index (BMI)
Time frame: Measured at baseline and preoperatively
Body Fat percentage
Time frame: Measured at baseline and preoperatively
Fat Free Mass (FFM)
Time frame: Measured at baseline and preoperatively
Muscle Mass
Time frame: Measured at baseline and preoperatively
Phase angle
Time frame: Measured at baseline and preoperatively
Satisfaction and acceptability
Time frame: Preoperative assessment
Incidents of adverse events (prehabilitation safety and tolerability)
Time frame: Measured from Baseline to Preoperatively
Quality adjusted life years
Time frame: Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
Prehabilitation cost-effectiveness
Time frame: Measured at 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 28489682Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
- Background: PubMed 26756766Barakat HM, Shahin Y, Khan JA, McCollum PT, Chetter IC. Preoperative Supervised Exercise Improves Outcomes After Elective Abdominal Aortic Aneurysm Repair: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):47-53. doi: 10.1097/SLA.0000000000001609.
- Background: PubMed 28990651Tew GA, Batterham AM, Colling K, Gray J, Kerr K, Kothmann E, Nawaz S, Weston M, Yates D, Danjoux G. Randomized feasibility trial of high-intensity interval training before elective abdominal aortic aneurysm repair. Br J Surg. 2017 Dec;104(13):1791-1801. doi: 10.1002/bjs.10669. Epub 2017 Oct 9.
- Background: PubMed 34236703Fenton C, Tan AR, Abaraogu UO, McCaslin JE. Prehabilitation exercise therapy before elective abdominal aortic aneurysm repair. Cochrane Database Syst Rev. 2021 Jul 8;7(7):CD013662. doi: 10.1002/14651858.CD013662.pub2.
- Background: PubMed 30272585Staiger RD, Cimino M, Javed A, Biondo S, Fondevila C, Perinel J, Aragao AC, Torzilli G, Wolfgang C, Adham M, Pinto-Marques H, Dutkowski P, Puhan MA, Clavien PA. The Comprehensive Complication Index (CCI(R)) is a Novel Cost Assessment Tool for Surgical Procedures. Ann Surg. 2018 Nov;268(5):784-791. doi: 10.1097/SLA.0000000000002902.
- Derived from this study: PubMed 41460856Coca-Martinez M, Doonan RJ, Gillis C, Mackenzie K, Obrand DI, Bayne JP, Steinmetz OK, Girsowicz E, Lopez-Baamonde M, Jessula S, Yugueros X, Martinez-Palli G, Gill HL. The PREHAAAB Trial: Multimodal prehabilitation for patients awaiting open abdominal aortic aneurysm repair - A study protocol for an international randomized controlled trial. PLoS One. 2025 Dec 29;20(12):e0339473. doi: 10.1371/journal.pone.0339473. eCollection 2025.
- 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.
Marie-Amelie Lucaszewski, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Prehabilitation in people with Abdominal Aortic Aneurysm, 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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Mar 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Gill, MD (+1 514.934.1934 ext. 35113, heather.gill@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications measured by the Comprehensive Complication Index (CCI) (time frame: CCI will be measured from admission to 6 weeks postoperatively). 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 NCT05756283, which also lists 6 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 6 Mar 2023.