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The Effect of Exercise on Wound Healing While Off-loading

2021年10月15日 更新者：Deborah M. Wendland, Ph.D.、Mercer University

The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer.

While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.

研究类型

介入性

注册 (预期的)

15

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。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30309
        • 招聘中
        • Piedmont Healthcare
        • 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:

  • Have diabetes
  • Have an active plantar ulceration
  • With or without peripheral neuropathy
  • Able to safely exercise
  • Receiving care for their plantar ulceration, including off-loading

Exclusion Criteria:

- Presence of an untreated infection, osteomyelitis, or gangrene

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：Exercise Added to Off-loading
Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions. Wound care will continue at the facility as is standard, utilizing off-loading.
行为的：Exercise
Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading.

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
Wound measurement size
大体时间：Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm^2) and/or volume (cm^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.
Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.

次要结果测量

结果测量
措施说明
大体时间
Summary of Diabetes Self-Care Activities Scale
大体时间：Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Participation in exercise. Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2). Scores on each question could range from 0 to 7 days. The higher the number, the more days the individual participates in the activity or exercise.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Body Mass Index
大体时间：Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Height and weight measurements will be combined and reported as BMI and measured in kg/m^2.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Physical activity data using an activity monitor (e.g. StepWatch).
大体时间：Measured at baseline for one week.
A week-long measurement of strides will be taken at the begin of the study.
Measured at baseline for one week.
Vibration sense
大体时间：Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy. A higher score would indicate decreased sensory perception of vibration.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference
大体时间：Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference will be taken in cm as a marker of body composition.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).

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。

赞助

Mercer University

调查人员

  • 首席研究员：Deborah M. Wendland、Mercer University

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)

2021年5月14日

初级完成 (预期的)

2023年5月1日

研究完成 (预期的)

2023年5月1日

研究注册日期

首次提交

2020年2月19日

首先提交符合 QC 标准的

2020年2月19日

首次发布 (实际的)

2020年2月21日

研究记录更新

最后更新发布 (实际的)

2021年10月25日

上次提交的符合 QC 标准的更新

2021年10月15日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • H1908192

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified closure rate data will be made available through a repository upon conclusion of the study and its dissemination.

IPD 共享时间框架

Data will be available following the study conclusion and its dissemination (6 months after publication).

IPD 共享访问标准

The information will be shared with researchers for meta-analyses through the data repository.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

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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