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临床试验/NCT03064529
NCT03064529已完成不适用

A Novel Approach to Inpatient Pediatric Physical Activity Measurement - The 6th Vital Sign

Ann & Robert H Lurie Children's Hospital of Chicago2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
2
主要终点
Change in physical activity as measured by accelerometer data

研究概览

简要总结

The present study aims to establish the feasibility of the clinical use of 3-axis accelerometers to measure physical activity in hospitalized children after elective surgery.

详细描述

Purpose:

A nearly universal aspect of hospitalization is a loss of physical activity due to confinement to bed, deconditioning, respiratory compromise, and pain with recovery comprising multifactorial components such as the return to activity, adequate pain control, and overall neurologic function. Assessment of recovery from surgery and the ability to return to full, normal activity has previously been dependent upon subjective clinical evaluation that are subject to observer-to-observer variability, selection bias, or variable interpretation of the qualitative description of movement. Bedside assessments utilizing an accelerometer could change clinical practice by having readily available, quantifiable, reliable and highly accurate data for healthcare providers when they make day-to-day decisions of medical care, as. The present study aims to establish the feasibility of the clinical use of 3-axis accelerometers to measure physical activity in the hospitalized children after abdominal surgery.

Methods:

Participants:

The target study population will be 25 English- or Spanish-speaking children ages 3-18 undergoing elective abdominal surgery with anticipated overnight hospitalization of at least one day. Children must be freely ambulatory without any pre-existing mobility-limitations. Study enrollment and recruitment will occur in Lurie outpatient urology and pediatric surgery clinics over a 6 month period. Parental/guardian consent will be obtained at the preoperative clinical visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children ages 3-18 undergoing elective surgery with anticipated overnight hospitalization of at least one day

排除标准

  • Any children who are non-ambulatory, have any pre-existing mobility limitations, or have a doctor-ordered physical activity limit >48 hours post surgery. Also, patients with surgery scheduled less than 7 days out as protocol calls for the accelerometer to be worn for 7 days pre-surgery

结局指标

主要结局

Change in physical activity as measured by accelerometer data

时间窗: Continuous measurement beginning 1 week before surgery (when the accelerometer is placed on the wrist) and ending 2 weeks after (when the accelerometer is removed from the wrist)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fizan Abdullah, MD

Division Head

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (2)

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