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临床试验/NCT05986617
NCT05986617终止不适用

Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

University of Iowa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
2
主要终点
Device Impact on Length of Time Until Surgical Indication

研究概览

简要总结

Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have been suggested as ineffective and counterproductive. Furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. At the University of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers, and BIA has recently been incorporated into wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA.

This study, a randomized controlled trial, aims to recruit adult patients with class III obesity presenting to the arthroplasty-obesity clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable BIA wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching.

This study aims to identify if the use of a wearable BIA wristband aids in the desired body composition changes. In addition, this study aims to quantify the body composition changes exhibited by each cohort. Finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >/= 18 years
  • BMI > 40kg/m2
  • Presenting to bariatric arthroplasty clinic with desire for total joint arthroplasty procedure
  • Owns a smartphone capable of handling iOS or Google Play apps
  • Has a wrist circumference less than or equal to 7.7"

排除标准

  • Has a pacemaker or other electronic pacemaker placement
  • Inability to complete study protocols
  • Inability to stand unsupported for 60-90 seconds
  • Does not own a smart phone capable of handling iOS or Google Play apps
  • Has a wrist circumference greater than 7.7"

研究组 & 干预措施

Control Group

No Intervention

Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

Wearable Device Group

Experimental

Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

干预措施: InBody Band 2 (Device)

结局指标

主要结局

Device Impact on Length of Time Until Surgical Indication

时间窗: Maximum 12 months prior to TJA

In this RCT, we analyzed the impact of the wearable device (band) on length of time until surgical indication

次要结局

  • Surgical Outcomes(24 months postoperatively)
  • Body Composition Changes Quantified(Maximum 12 months prior to TJA)

研究者

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

Jacob M. Elkins

Assistant Professor of Orthopedics and Rehabilitation

University of Iowa

研究点 (2)

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