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Exercise In Critical Limb Ischaemia Patients Having Surgery Proof of Concept (EXERCISE)

Exercise In Critical Limb Ischaemia Patients Having Surgery

Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and therefore have no option but to undergo bypass or amputation surgery. This presents a major physical challenge to the body and patients with low fitness will struggle to overcome the effects of the surgical trauma. Currently there is a high risk of a poorer outcome for CLI patients than with most other surgical procedures, as demonstrated by high rates of complications (20-46%) and 30 day mortality (7.5-13.5%). Up to 30% of people will die within the first year. Exercise and respiratory muscle training, before surgery, has shown a reduction in complications in other surgical specialties.

Around 50% of CLI patients present as an emergency, meaning training before admission is not feasible, so the Investigator proposes to see if training during the hospital stay will aid a better recovery. However, as this has not been done in vascular surgical patients the investigator needs to initially test if this intervention is possible in this patient group in an acute hospital setting.The aim of this proof of concept single cohort study is to assess whether an exercise intervention, started on hospital admission and continued post-surgery, for the duration of the hospital admission, is safe, acceptable, well tolerated and feasible to run in an acute ward setting.

The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge. The Investigator will assess safety by recording adverse events and acceptability by adherence to exercise programme and qualitative interviews. The Investigator will evaluate processes and completeness of data collection and describe before and after measures of physical fitness.

研究概览

地位

完全的

干预/治疗

研究类型

介入性

注册 (实际的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hull、英国、HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 18 years old or over
  2. Willing to participate and able to give written informed consent
  3. Clinical diagnosis of critical limb ischaemia or Fontaine Class III-IV or Rutherford Class 4-6
  4. Admitted to the vascular surgical ward for lower limb surgery

Exclusion Criteria:

  1. Patients presenting who have diabetes are presenting with acute limb ischaemia with no history of PAD
  2. Cognitive Impairment as demonstrated by not being able to safely follow instructions.
  3. Unable to understand or read English
  4. Absolute contraindications to exercise including:-

    • Acute MI
    • Ongoing unstable angina
    • Uncontrolled cardiac arrhythmia with hemodynamic compromise
    • Active endocarditis
    • Symptomatic severe aortic stenosis
    • Decompensated heart failure
    • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
    • Acute myocarditis or pericarditis
    • Acute aortic dissection
  5. Physical disability that precludes safe and adequate exercise as determined by the clinical team
  6. Contraindications to IMT including:-

    • A history of spontaneous pneumothrorax (ie not due to traumatic injury)
    • A pneumothorax due to traumatic injury that has not fully healed
    • A burst eardrum that has not fully healed or any other condition of the eardrum
    • Unstable asthma and abnormally low perception of dyspnoea

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Exercise
Exercise and respiratory muscle training before surgery
The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Primary (Mortality)
大体时间:30 days
Mortality
30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年8月3日

初级完成 (实际的)

2020年7月31日

研究完成 (实际的)

2020年7月31日

研究注册日期

首次提交

2019年7月31日

首先提交符合 QC 标准的

2019年8月1日

首次发布 (实际的)

2019年8月2日

研究记录更新

最后更新发布 (实际的)

2020年8月31日

上次提交的符合 QC 标准的更新

2020年8月28日

最后验证

2020年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R2372

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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