Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Postoperative complications measured by the Comprehensive Complication Index (CCI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Participants must have the ability to give individual informed consent.
排除标准
- •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.
研究组 & 干预措施
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Patient Education (Behavioral)
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Prehabilitation (Other)
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Exercise therapy (Behavioral)
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Smoking cessation counselling (Behavioral)
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Nutritional counselling (Behavioral)
Prehabilitation arm
Participants in the intervention arm will receive a prehabilitation bundle between the time of diagnosis of abdominal aortic aneurysm and open surgical repair. The prehabilitation bundle will consist of 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.
干预措施: Psychological intervention (Behavioral)
结局指标
主要结局
Postoperative complications measured by the Comprehensive Complication Index (CCI)
时间窗: 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
次要结局
- Change in aerobic function(Measured at baseline, preoperatively and 6 weeks postoperatively)
- Physical activity(Measured at baseline, preoperatively and 6 weeks postoperatively)
- Quality of life(Measured at baseline, preoperatively and 6 weeks postoperatively)
- Anxiety(Measured at baseline, preoperatively and 6 weeks postoperatively)
- Compliance(Measured from baseline to preoperatively)
- ICU Length of stay(From admission to 6 weeks postoperatively)
- Hospital length of stay(From admission to 6 weeks postoperatively)
- Reinterventions(From admission to 6 weeks postoperatively)
- Readmission(at 6 weeks and at 1 year postoperatively)
- Emergency Room visits(at 6 weeks and at 1 year postoperatively)
- Mortality(From admission to 1 year post operatively.)
研究者
Samuel Jessula
Assistant Professor in Surgery, Division of Vascular Surgery
Nova Scotia Health Authority