Efficacy of Pre-Operative Prehabilitation in Patients Undergoing Open Surgery for Abdominal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- functional WHODAS 2.0 score
研究概览
简要总结
This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.
详细描述
Open surgery of abdominal aortic aneurysms (AAA) is the reference treatment in a large number of cases. This is a heavy procedure performed in patients around 70 years of age.
In post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients.
The goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living.
The pre-habilitation protocol includes 3 parts :
- Oral nutrition ensures adequate caloric and protein intake to support muscle anabolism
- Muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently
- Cardio-respiratory endurance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an abdominal aortic aneurysm (Thoraco-abdominal aneurysm type 4/Supra renal/Juxta-renal/Sub renal) treated with conventional surgery.
- •Surgical indication of aneurysm by size (50-55mm)
排除标准
- •- Patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.
研究组 & 干预措施
PREHABILITATION GROUP
Initial visit with the adaptive rehabilitation physician, 6-8 weeks prior to surgery:
- Clinical examination with Wood classification description of impairments, activity limits and participation restrictions.
- Assessment of environmental resources
- Definition with the patient of the extended ambulatory pre-habilitation protocol, identification with the post-operative rehabilitation pathway,
- Provide the patient with a follow-up workbook of the personalized pre-approval protocol and, if the patient's condition requires it, orders for physiotherapy.
Then apply the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician.
- Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).
Mail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.
干预措施: PREHABILITATION (Other)
CONTROL GROUP
Support without pre-approval with application of other common practices of the service.
Post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up).
Mail-out of WHODAS 2.0 EQ-5D-5L and DIJON questionnaires at 3 and 6 months post-operative.
结局指标
主要结局
functional WHODAS 2.0 score
时间窗: 3 months after the open surgery for AAA
the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities
functional WHODAS 2.0 score
时间窗: T0 : Right after the open surgery for AAA
the WHODAS 2.0 score ranges from 12 to 60 : 12 representing no difficulty at all, 60 representing worst difficulty to engage in usual activities
次要结局
未报告次要终点