Clinical trial NCT06830967: Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair
Official title: Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Prehabilitation
AAA - Abdominal Aortic Aneurysm
Keywords: AAA
prehabilitation
abdominal aortic aneurysm
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications measured by the Comprehensive Complication Index (CCI)
timeFrame: CCI will be measured from admission to 6 weeks postoperatively
Secondary outcomes:
measure: Change in aerobic function
timeFrame: Measured at baseline, preoperatively and 6 weeks postoperatively
measure: Physical activity
timeFrame: Measured at baseline, preoperatively and 6 weeks postoperatively
measure: Quality of life
timeFrame: Measured at baseline, preoperatively and 6 weeks postoperatively
measure: Anxiety
timeFrame: Measured at baseline, preoperatively and 6 weeks postoperatively
measure: Compliance
timeFrame: Measured from baseline to preoperatively
measure: ICU Length of stay
timeFrame: From admission to 6 weeks postoperatively
measure: Hospital length of stay
timeFrame: From admission to 6 weeks postoperatively
measure: Reinterventions
timeFrame: From admission to 6 weeks postoperatively
measure: Readmission
timeFrame: at 6 weeks and at 1 year postoperatively
measure: Emergency Room visits
timeFrame: at 6 weeks and at 1 year postoperatively
measure: Mortality
timeFrame: From admission to 1 year post operatively.
Other outcomes:
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