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Reducing Fall Risks for Adults With Obesity (ObesityFalls)

2019年7月17日 更新者:Simone V. Gill、Boston University Charles River Campus

A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.

研究概览

详细说明

Obesity has a negative impact on aspects of walking associated with fall risks. After weight loss surgery, adults show improvements in walking. However, those who undergo surgery still show deficits in walking and an additional group of individuals do not undergo the procedure. Our objective was to examine if practice could improve gait patterns associated with fall risks before patients underwent weight loss surgery. Adults with obese body mass index between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery procedure walked under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables selected included velocity (cm/s), cadence (steps/minute), step length (distance between consecutive steps), step width (lateral distance between feet), single limb support time (amount of time spent on one leg during the walking cycle), and double limb support time (amount of time spend on two legs during the walking cycle).

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

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 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • between 30 and 60 years old
  • eligible to undergo Roux-en-Y gastric bypass surgery
  • walk independently without assistive devices

Exclusion Criteria:

  • scheduled to undergo knee surgery
  • receiving dialysis
  • being treated for cancer

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:治疗
  • 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
实验性的:Reducing Fall Risks in Obesity
Adults with obesity will be asked to perform the obstacle crossing intervention for adults with obesity for reducing falls risk. This will involve crossing obstacles of different heights under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters will be collected using a gait carpet and body-worn sensors.
The obstacle crossing intervention will be done for reducing falls risks in obesity. The intervention will provide gait practice to individuals with obesity who are eligible for and prior to weight loss 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
Velocity (cm/s)
大体时间:The change from baseline velocity (cm/s) at 12 months
walking speed
The change from baseline velocity (cm/s) at 12 months

次要结果测量

结果测量
措施说明
大体时间
Cadence (steps per minute)
大体时间:The change from baseline cadence (steps per minute) at 12 months
steps per minute
The change from baseline cadence (steps per minute) at 12 months
Step width (cm)
大体时间:The change from baseline step width (cm) at 12 months
lateral distance between feet
The change from baseline step width (cm) at 12 months
single limb support time (msec)
大体时间:The change from baseline single limb support time (msec) at 12 months
time spent balancing on one leg
The change from baseline single limb support time (msec) at 12 months
double limb support time (msec)
大体时间:The change from baseline double limb support time (msec) at 12 months
time spent balancing on both legs
The change from baseline double limb support time (msec) at 12 months
step length (cm)
大体时间:The change from baseline step length (cm) at 12 months
distance between consecutive steps
The change from baseline step length (cm) at 12 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。

调查人员

  • 首席研究员:Simone V Gill、Boston University Charles River Campus

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)

2014年9月1日

初级完成 (实际的)

2019年7月15日

研究完成 (实际的)

2019年7月15日

研究注册日期

首次提交

2018年5月25日

首先提交符合 QC 标准的

2018年6月13日

首次发布 (实际的)

2018年6月15日

研究记录更新

最后更新发布 (实际的)

2019年7月18日

上次提交的符合 QC 标准的更新

2019年7月17日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 3820E
  • R03AR066344-01A1 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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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