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Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35

2019年2月15日 更新者：Feelwell Compression

Examining the Impact of the Use of a Custom-fitted, FeelWell™ Compression Garment to Improve the Quality of Life of Individuals With a BMI ≥35

To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing an individual's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.

研究概览

地位

未知

条件

干预/治疗

详细说明

Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.

The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health.

研究类型

介入性

注册 (预期的)

30

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

  • 美国
    • Virginia
      • Shirlington、Virginia、美国、22206
        • 招聘中
        • Washington Center for Weight Management and Research, Inc.
        • 接触：
        • 接触：
        • 首席研究员：
          • Domenica Rubino, MD
        • 副研究员：
          • Rachel Trope, MS
        • 副研究员：
          • Mike Reing, MS

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female, over 18 years old.
  • Subjects with a BMI of ≥ 35.
  • Subjects in any stage of weight loss or maintenance.

Exclusion Criteria:

  • Inability to put on or have help in putting on garment.
  • Inability to participate in movement and exercise intervention.
  • Panniculus grade >3 at baseline or other body habitus that limits mobility.
  • Duke Activity Status Index (DASI) score < 3.62
  • Medical condition limiting participation in trial or basic mobility.
  • Current participation in a physical therapy program.
  • Unwillingness to participate fully in trial.
  • Participation in another trial at the same time.
  • Patient Health Questionnaire (PHQ)-9≥15.
  • Current or expected pregnancy
  • Investigator's discretion

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：随机化
  • 介入模型：并行分配
  • 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：FeelWell™ Compression garment use with increase mobility

Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.

Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity.
设备：FeelWell™ Compression garment

Registered FDA class I device:

The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.

行为的：Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
其他：Increase mobility
For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial.
行为的：Increase Mobility
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

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
6- minute walk test- distance walked
大体时间：baseline, 1, 3, 6 and 12 months
6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline.
baseline, 1, 3, 6 and 12 months
6- minute walk test- Perceived exertion
大体时间：baseline, 1, 3, 6 and 12 months
The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline.
baseline, 1, 3, 6 and 12 months
SF-36 physical component sub-score
大体时间：baseline, 3, 6 and 12 months
SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning.
baseline, 3, 6 and 12 months
30 Second Chair Stand
大体时间：baseline, 1, 3, 6 and 12 months
A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded.
baseline, 1, 3, 6 and 12 months
Brief Pain Inventory-Interference sub-score
大体时间：baseline, 1, 3, 6 and 12 months
A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded.
baseline, 1, 3, 6 and 12 months
Steps per day measured by accelerometer
大体时间：baseline, 6 months and 1 year
The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
baseline, 6 months and 1 year
Weight Self Stigma questionnaire
大体时间：baseline, 1, 3, 6 and 12 months
A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma.
baseline, 1, 3, 6 and 12 months

次要结果测量

结果测量
措施说明
大体时间
Lean body mass
大体时间：baseline, 12 months
Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported.
baseline, 12 months
Fat mass
大体时间：baseline, 12 months
Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.
baseline, 12 months
Bone density
大体时间：baseline, 12 months
Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.
baseline, 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。

赞助

Feelwell Compression

合作者

Washington Center for Weight Management and Research, Inc.

调查人员

  • 首席研究员：Domenica Rubino, MD、Washington Center for Weight Management and Research

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。

一般刊物

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)

2019年2月13日

初级完成 (预期的)

2020年7月1日

研究完成 (预期的)

2020年7月1日

研究注册日期

首次提交

2018年12月13日

首先提交符合 QC 标准的

2019年1月7日

首次发布 (实际的)

2019年1月10日

研究记录更新

最后更新发布 (实际的)

2019年2月19日

上次提交的符合 QC 标准的更新

2019年2月15日

最后验证

2019年2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

  • FeelWell2018

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

Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.

IPD 共享时间框架

Data will be available within 6 months of publication.

IPD 共享访问标准

Researchers must provide evidence that the data are being requested for analysis in a scientific study.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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

是的

在美国制造并从美国出口的产品

是的

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.

生活质量的临床试验

FeelWell™ Compression garment的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Djibouti

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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