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Promotion of Ambulation Before Non-cardiac Surgery (PAMP-Phase2)

Impact of a Routine of Pre-surgical Walk for Non Cardiac Adult Patients Compared to Conventional Intervention (Not Recommended Exercise) in Reducing the Length of Hospital Stay and the Time of Onset of Ambulation.

Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.

Secondary

  1. Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
  2. Evaluate the incidence of falls during hospitalization.

Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.

Expected results

研究概览

详细说明

Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.

Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.

研究类型

介入性

注册 (实际的)

368

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

    • Cundinamarca
      • Bogotá、Cundinamarca、哥伦比亚
        • Fundación Cardioinfantil Instituto de Cardiología
    • Santander
      • Bucaramanga、Santander、哥伦比亚
        • Clinica Carlos Ardila Lulle-FOSCAL

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

30年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • undergoing non-cardiac surgery
  • general anesthesia or epidural or spinal anesthesia
  • age ≥ 30 years
  • able to walk and communicate

Exclusion Criteria:

  • having any alteration of their state of consciousness
  • altered mental status and communication

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:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Walk prescription
Walk prescription for all weeks before non-cardiac surgery. Duration of walk must be of 30-40 minutes every day for five days at the week or until complete 150 minutes at the week, for all weeks up to the surgery.
30-40 minutes daily, for five days at the week, all weeks up to surgery.
其他名称:
  • 康复前
其他:Conventional care
Currently patients do not receive exercise (walk)-prescription before non cardiac surgery.
Patient do not walk before surgery

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
Length of stay
大体时间:Up 40 weeks in hospitalization
Total stay hours
Up 40 weeks in hospitalization

次要结果测量

结果测量
措施说明
大体时间
Falls
大体时间:Up 40 weeks in hospitalization
Fall event reported in patients´ charts
Up 40 weeks in hospitalization
Ischemic events
大体时间:Up 40 weeks in hospitalization
Myocardial infarction or stroke
Up 40 weeks in hospitalization
Time to the first walk
大体时间:Up 40 weeks in hospitalization
First time out of the bed registered in patients´charts
Up 40 weeks in hospitalization

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。

调查人员

  • 首席研究员:Olga Cortés, PI、Fundación Cardioinfantil Instituto de Cardiología

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2016年5月1日

初级完成 (实际的)

2017年12月31日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2017年7月5日

首先提交符合 QC 标准的

2017年7月7日

首次发布 (实际的)

2017年7月11日

研究记录更新

最后更新发布 (实际的)

2018年3月20日

上次提交的符合 QC 标准的更新

2018年3月16日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • CEIC-2224-2015

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Data will be registered in indepenedent filles in folders; and also data will be typed on the PAMP Data base (CARDIECOL). Data can be monitored by a coordinator.

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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