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Exercise Prior to Oesophagectomy (ExPO)

2016年11月8日 更新者:University of East Anglia

A Pre-operative Personalised Exercise Programme to Improve Physical Fitness and Reduce Post-operative Cardiopulmonary Complications After Oesophagectomy in Patients With Oesophageal Adenocarcinoma: A Feasibility Randomised Controlled Trial

The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.

研究概览

详细说明

The number of patients with oesophageal cancer is rising dramatically in the UK. Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients. However, oesophagectomy is a major operation with a high risk of complications. Around 1 in 3 patients will suffer such a complication after surgery, mostly due to heart or lung problems. Most complications are not due to the surgery itself, but related to the patient's physical fitness before their operation. Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient's physical fitness before their operation. The ExPO team has developed a pre-operative Personalised Exercise Programme (my-PEP), specifically for patients undergoing oesophagectomy. my-PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant's potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial. In total, 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each. One arm will receive my-PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home. The research objectives are to obtain feasibility data on whether my-PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care. Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether my-PEP reduces complications. If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether my-PEP can reduce complications after oesophagectomy. If so, my-PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.

研究类型

介入性

注册 (预期的)

32

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

    • Norfolk
      • Norwich、Norfolk、英国、NR4 7TJ
        • 招聘中
        • University of East Anglia
        • 接触:
        • 接触:

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:

  • Patients with oesophageal adenocarcinoma (OAC) who are scheduled for neoadjuvant chemotherapy and subsequent oesophagectomy.
  • Must have histological evidence of OAC
  • Must be capable of giving informed consent and complying with trial procedures.

Exclusion Criteria:

  • Patients with oesophageal squamous cell carcinoma.
  • Patients with concomitant illness or disability that makes them unsuitable for an exercise programme, as determined by a clinician (e.g. severe musculoskeletal or neurological disease, unstable angina, severe aortic stenosis, uncontrolled dysrhythmias and uncompensated heart failure).
  • WHO performance status 3 (capable of only limited self-care, confined to a bed or chair more that 50% of waking hours) or greater.
  • Grade 5 (too breathless to leave the house, or breathless when undressing) on MRC dyspnoea scale.

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:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
其他:控制
标准护理
Written advice on exercise at home
实验性的:Intervention
A pre-operative personalised exercise programme (my-PEP).
A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .

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
Recruitment rate
大体时间:0 months
The number of participants recruited from all eligible patients
0 months
Drop-out rate
大体时间:12 months
Number of patients that drop-out from trial
12 months
Decline rate
大体时间:0 months
Number of patients that decline to participate in the trial
0 months
Change in physical activity levels
大体时间:0 and 4 months
Measured with International Physical Activity Questionnaire (IPAQ)
0 and 4 months
Change in attitudes to exercise
大体时间:0 and 4 months
Measured with Determinates of Physical Activity Questionnaire (DPAQ)
0 and 4 months
Trial Adherence
大体时间:12 months
Physical activity diary used to assess adherence
12 months
Adverse Events
大体时间:12 months
The number of adverse events during the trial assessed using CTCAE
12 months
Change in physiological fitness
大体时间:0 and 4 months
Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer
0 and 4 months
Change in respiratory muscle strength
大体时间:0 and 4 months
Assessed with mean inspiratory pressure testing in cmH20
0 and 4 months
Post-operative cardiopulmonary complications
大体时间:90-days post surgery
Cardiopulmonary complication rates as per ECCG definition.
90-days post surgery
Post-operative non-cardiopulmonary complications
大体时间:90-days post surgery
Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.
90-days post surgery
Post-operative length of stay
大体时间:90-days post surgery
Duration of post-operative stay in days
90-days post surgery
Post-operative mortality
大体时间:90-days post surgery
Number of post-operative deaths
90-days post surgery
Change in Quality of Life
大体时间:0, 4, 7 months
Assessed using QLQ C30 and OG25
0, 4, 7 months

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

2016年9月1日

初级完成 (预期的)

2017年9月1日

研究完成 (预期的)

2018年4月1日

研究注册日期

首次提交

2016年10月28日

首先提交符合 QC 标准的

2016年11月8日

首次发布 (估计)

2016年11月11日

研究记录更新

最后更新发布 (估计)

2016年11月11日

上次提交的符合 QC 标准的更新

2016年11月8日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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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