Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Prehabilitation
  Prehabilitation will consist of exercise therapy, smoking cessation, nutritional counselling, psychological intervention and patient education.
• Поведенческое Exercise therapy
  Exercise therapy will consist of tailored 6-week prescribed exercise program consisting of 150-minutes of moderate-vigorous exercise weekly based on patient-to-patient resource availability (eg. neighborhood walk, body-weight exercises). It will target moderate intensity (11-13 on the Borg Rating of perceived exertion scale) and will be adjusted throughout the program as required. It will target aerobic, strength and inspiratory muscle training (IMT). Participants will receive a logbook where th
• Поведенческое Smoking cessation counselling
  Smoking cessation will be provided through motivational interviewing with a counselor who will assess participant's smoking status, willingness and readiness to quit and provide prescriptions for nicotine replacement therapy in combination with non-nicotinic pharmacotherapy (Varenicline, Buprorprion) as appropriate
• Поведенческое Nutritional counselling
  Nutritional counseling will be provided through consultation with a registered dietician. Participants will be educated on correct portion sizes, building a balanced plate, learning sources and importance of protein, importance of timing and spacing of meals, along with practicing mindful eating. Promotion and encouragement of dietary changes to ensure balanced intake with adequate protein, weight management, and the regulation of blood glucose will be discussed. Possible barriers to attain the
• Поведенческое Psychological intervention
  Participants will receive one hourly session of psychological intervention called "surgical stress tolerance training" with a trained counselor. In this session the psychosocial specialist will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being and ways of coping with surgery. The importance of the patient's active participation in the preparation for surgery and healing process will also be discussed. All par
• Поведенческое Patient Education
  Patient education will be provided through virtual consultations with a vascular surgery nurse practitioner. These consultations will describe to the patient their journey pre and post-operatively, what to expect and what they are likely to experience, both physically and emotionally. These consultations will also ensure participants have a support person at home available for supervision during prehabilitation and available during their recovery. Additionally, they will ensure that their home i

Первичные конечные точки

• Postoperative complications measured by the Comprehensive Complication Index (CCI) [Срок оценки: CCI will be measured from admission to 6 weeks postoperatively]

Вторичные конечные точки (11)

• Change in aerobic function [Срок оценки: Measured at baseline, preoperatively and 6 weeks postoperatively]
• Physical activity [Срок оценки: Measured at baseline, preoperatively and 6 weeks postoperatively]
• Quality of life [Срок оценки: Measured at baseline, preoperatively and 6 weeks postoperatively]
• Anxiety [Срок оценки: Measured at baseline, preoperatively and 6 weeks postoperatively]
• Compliance [Срок оценки: Measured from baseline to preoperatively]
• ICU Length of stay [Срок оценки: From admission to 6 weeks postoperatively]
• Hospital length of stay [Срок оценки: From admission to 6 weeks postoperatively]
• Reinterventions [Срок оценки: From admission to 6 weeks postoperatively]
• Readmission [Срок оценки: at 6 weeks and at 1 year postoperatively]
• Emergency Room visits [Срок оценки: at 6 weeks and at 1 year postoperatively]
• Mortality [Срок оценки: From admission to 1 year post operatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06830967 · 68360

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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