Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair

Not Applicable

Not yet recruiting

• Conditions: Abdominal Aortic Aneurysm; Prehabilitation; AAA - Abdominal Aortic Aneurysm

• Registration Number: NCT06830967
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).

Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of moderate exercise coordinated remotely through the cardiology rehabilitation program, whereas all other interventions will be consultations through videoconferencing or phone interactions. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.

This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.

Detailed Description

The time between diagnosis and operative intervention represents an untapped opportunity to optimize patient readiness for surgery and augment their function prior to undergoing a physiological stress, rather than purely recovering post-operatively. Vascular surgery patients are frail and primed to benefit from such interventions and upcoming surgery is a strong motivator for behavioral change. In this proposal, the investigators outline our vision for a prehabilitation program for patients undergoing elective open aortic aneurysm repair (AAA).

Participants scheduled to undergo AAA repair would receive, in addition to standard of care, 5 main interventions: exercise therapy; smoking cessation counseling and pharmacotherapy; nutritional counseling; psychological readiness planning and patient education. Exercise therapy will consist of 6 weeks of prescribed moderate exercise coordinated remotely through the physiotherapy. Smoking cessation will consist of motivational interview with adjunctive pharmacotherapy prescribed as required. Nutritional assessment will be remotely coordinated with a certified dietician and psychological readiness and patient education will consist of 2 1 hour sessions with a counselor. Outcomes of interest include morbidity, mortality, predictors of completion of program, exercise function and quality of life.

This study is a pilot feasibility project and the first step in the creation of a long-term program that will improve patient clinical outcomes, exercise capacity quality of life and hopefully become an model for prehabilitation for other institutions across the country and raise the standard of care for vascular surgery patients.

Study Timeline

• Study First Submitted: 2025-01-29
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-01
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm at the Halifax Infirmary Hospital between January 2025-December 2025. Participants must have the ability to give individual 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.
• Inability to have a support person present during exercise therapy.
• Cognitive impairment that would impede understanding of study procedures or informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postoperative complications measured by the Comprehensive Complication Index (CCI)	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

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	From admission to 6 weeks postoperatively	Days from admission to discharge from the hospital
Reinterventions	From admission to 6 weeks postoperatively	Need for surgical reintervention due to surgical complications
Readmission	at 6 weeks and at 1 year postoperatively	Readmission to the hospital
Emergency Room visits	at 6 weeks and at 1 year postoperatively	Visits to the emergency room with or without admission to the hospita
Mortality	From admission to 1 year post operatively.	Mortality within 1 year of surgery.
ICU Length of stay	From admission to 6 weeks postoperatively	Intensive Care Unit length of stay
Change in aerobic function	Measured at baseline, preoperatively and 6 weeks postoperatively	Change in 6 minute walk test. The 6 minute walk test is the maximum distance walked within a 6 minute time frame.
Physical activity	Measured at baseline, preoperatively and 6 weeks postoperatively	Measured by the Yale physical activity survey (YPAS). The YPAS has 2 sections that provide 3 summary indices and a seasonal adjustment score, all of which are calculated as a recall of physical activity in a typical week in the past month. The range is 0-142, with higher scores suggesting higher physical activity.
Quality of life	Measured at baseline, preoperatively and 6 weeks postoperatively	The SF 36 measures eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions via survey. The SF 36 range is 0-100, with higher scores indicting higher quality of life.
Anxiety	Measured at baseline, preoperatively and 6 weeks postoperatively	Anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) 0 (no anxiety)- 21 (maximal anxiety).
Compliance	Measured from baseline to preoperatively	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 (%)