The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Behavioral: Multimodal Prehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Gill, MD; Phone Number: 35113 +1 514.934.1934; Email: heather.gill@mail.mcgill.ca
• Study Contact Backup: Name: Marie-Amelie Lucaszewski, PhD; Phone Number: 35113 +1 514.934.1934

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • MUHC-RIMUHC Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Prehabilitation; 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.	Behavioral: Multimodal Prehabilitation; EXERCISE; Supervised exerciseHigh intensity interval trainingStrength exercise; Home-based exercise / promotion of physical activityLow-moderate intensity aerobic trainingInspiratory muscle trainingLow-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.
No Intervention: Control group (standard of care); 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	CCI will be measured from admission to 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Length of stay	Intensive Care Unit length of stay	From admission to 6 weeks postoperatively
Hospital length of stay	Days from admission to discharge from the hospital	From admission to 6 weeks postoperatively
Reinterventions	Need for surgical reintervention due to surgical complications	from surgery day to 6 week postoperatively
Readmission	Readmission to the hospital	at 6 weeks and at 1 year postoperatively
Emergency Room visits	Visits to the emergency room with or without admission to the hospital	at 6 weeks and at 1 year postoperatively
6-Minute Walk Test	6-minute walk test	Measured at baseline, preoperatively and 6 weeks postoperatively
VO2 peak	Oxygen consumption at peak exercise	Measured at baseline and preoperatively
VO2 AT	Oxygen consumption at anaerobic Threshold	Measured at baseline and preoperatively
VE/VCO2	Minute ventilation/carbon dioxide production	Measured at baseline and preoperatively
Yale physical activity survey (YPAS)	Questionnaire of daily physical activity	Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively
SF36	Quality of life questionnaire	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 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 at baseline, preoperatively, 6 weeks and 1 year postoperatively
Patient Generated Subjective Global Assessment (PG-SGA)	Malnutrition assessment tool	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 from baseline to preoperatively
Fidelity to exercise intervention	Real training wattage and kg vs expected	Measured from baseline to preoperatively
Height	measurement of height in meters	Measured at baseline and preoperatively
Weight	measurement of Weight in kg	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 at baseline and preoperatively
Body Fat percentage	Measurement of body fat percentage using Bioelectrical Impedance Analysis	Measured at baseline and preoperatively
Fat Free Mass (FFM)	Measurement of body fa free mass in kg, using Bioelectrical Impedance Analysis	Measured at baseline and preoperatively
Muscle Mass	Measurement of muscle mass in kg, using Bioelectrical Impedance Analysis	Measured at baseline and preoperatively
Phase angle	Measurement of phase angle, using Bioelectrical Impedance Analysis	Measured at baseline and preoperatively
Satisfaction and acceptability	Intervention satisfaction and acceptability questionnaire	Preoperative assessment
Incidents of adverse events (prehabilitation safety and tolerability)	Incidence of adverse events and severe adverse events during prehabilitation program	Measured from Baseline to Preoperatively
Quality adjusted life years	Quality adjusted life years derived from SF36 data (SF6D)	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 at 1 year postoperatively

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)

Publications and helpful links

General 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.
• Barakat 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.
• Tew 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.
• Fenton 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.
• Staiger 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Nutrition; Prehabilitation; Postoperative Complications; Psychosocial intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PREHAAAB Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No