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临床试验/NCT01062594
NCT01062594已完成不适用

A Randomised Controlled Trial to Assess the Effect of a Pre-operative Supervised Exercise Programme on Outcome Following Intervention for Abdominal Aortic Aneurysms.

Hull University Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2009年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
2
主要终点
Composite outcome including cardiac, respiratory and renal complications

研究概览

简要总结

An aneurysm is a permanent and localized dilatation of an artery usually more than 50% of its normal diameter. Abdominal Aortic Aneurysms (AAA) is an aneurysm of the main artery of abdomen and affects 5% of men aged 65-74 years. Rupture of an aneurysm is the 10th leading cause of death in white men over 65 years of age in industrial countries. Treatment of asymptomatic AAA is considered when the diameter of an AAA reaches 5.5 cm. There are two treatment options available: conventional open surgical repair or endovascular repair, which is a less invasive mode of treatment. After the operation heart and lung complications are significant in patients undergoing major abdominal surgery. The commonest causes of death are due to heart problems. There are various studies which have shown benefits of pre operative exercise training in patients undergoing orthopaedic, lung and heart bypass surgery. Currently, there is no data available with regards to the effect of pre-operative (before operation) supervised exercise in patients undergoing surgery for an AAA.

The main aim of this study will be to determine whether a pre-operative supervised exercise programme improves post-operative (after operation) outcome, compared to standard treatment.

Patients will be entered in the study once a decision to repair their AAA has been made by the consultant. They will undergo pre-operative assessment and will be divided randomly into two groups. One group will have exercise training for 4-6 weeks before surgery and the other will not. After the operation they will be followed during the post-operative period to determine the presence or absence of complications. It is anticipated that complications will be less in the group which has undertaken exercise training before operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing open repair for an asymptomatic peri-renal and infra-renal abdominal aortic aneurysm.
  • Patients undergoing Endovascular aneurysm repair (EVAR).
  • Able to comply with study protocol.
  • Able to give informed consent.

排除标准

  • Patients with severe disabling disorders limiting mobility for example severe osteoarthritis.
  • Patients undergoing emergency repair of Abdominal Aortic Aneurysm.
  • Patients with thoraco abdominal aneurysms.
  • Patients unable to communicate in English.

研究组 & 干预措施

Supervised exercise group

Active Comparator

干预措施: Supervised exercise (Other)

Supervised exercise group

Active Comparator

干预措施: Role of exercise (Other)

Supervised exercise group

Active Comparator

干预措施: Supervised exercise program (Other)

Control group - no exercise

No Intervention

结局指标

主要结局

Composite outcome including cardiac, respiratory and renal complications

时间窗: First three months after intervention

次要结局

  • Length of ITU/ HDU stay, length of hospital stay (medical/ total), quality of life scores (SF-8 and EURQOL) & death within 30 days of surgery(First three months after intervention)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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