Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair-REHAB-AAA, a Randomised Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change of VO2max
研究概览
简要总结
Evidence about the benefit of cardiovascular rehabilitation (CR) after open or endovascular repair of an infrarenal aortic aneurysm is lacking. The positive effect of CR on the cardiovascular fitness, quality of life and mortality is well established in other cardiovascular fields like cardiac surgery.
The aim of this study is to determine whether participation in a structured CR, compared with standard postoperative care (SC), results in greater improvements in cardiorespiratory fitness in patients following abdominal aortic aneurysm repair.
The study will also evaluate whether CR, compared with SC, improves health-related quality of life, reduces cardiovascular risk-factors and adverse cardiovascular events and preserves of cognitive function over the follow-up period. Furthermore, the number of complications and reoperations will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an abdominal aortic aneurysm (AAA) and an indication for repair, ability to understand and willingness to sign a written informed consent document.
排除标准
- •Acute AAA repair
- •AAA size ≥7cm
- •Para/suprarenal AAA
- •AAA due to a connective tissue disorder
- •Impaired mobility
- •Life expectancy <12 months
- •Severe co-morbidities influencing or preventing CR (e.g. ≥COPD II, PAD ≥ Rutherford 3, dialysis)
- •Participation in another interventional study that may confound the study endpoints
- •Patients <18 years old
结局指标
主要结局
Change of VO2max
时间窗: Before the procedure and 1 year after aortic repair
Maximal oxygen uptake
6-minute walking distance (6MWD)
时间窗: Before the procedure and 1 year after aortic repair
Walking distance after 6 minutes
次要结局
- Change of the results of the The Short Form (36) Health Survey (SF-36) questionnaire(Before surgery and 1 year after aortic repair)
- Surgery related complications and reoperations(After 30 days and after 1 year after aortic repair.)
- Change of blood pressure(Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.)
- Mini-mental state examination(Preoperative and 1 year after aortic repair.)
- Major adverse cardiovascular events (MACE)(30 days and 1 year after aortic repair.)
- Serum lipid profile(Blood pressure and serum lipid profile preoperative and 1 year after aortic repair.)