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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05756283
• Other study ID #: PREHAAAB Trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2027

Study information

• Verified date: February 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Heather Gill, MD
• Phone: +1 514.934.1934
• Email: heather.gill[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Behavioral:
• Multimodal Prehabilitation
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.

Locations

Country	Name	City	State
Canada	MUHC-RIMUHC Royal Victoria Hospital	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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