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临床试验/NCT03853083
NCT03853083Unknown不适用

HYPOXI for Women With Lipedema

University of Arizona0 个研究点目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
Bioimpedence Scale Assessment of Total Body Water

研究概览

简要总结

The proposed study is for women with lipedema, a painful fat disorder where fat cannot be lost from the legs and hips with diet and exercise. The study will compare the use of the specialized exercise equipment called HYPOXI, which is like a bike but you lie down and air circulates around the participant's legs like a vacuum with pressure increasing and decreasing in cycles over time. The goal of the study is to see if using a HYPOXI bike compared to a regular recumbent (sit down) bike helps women with lipedema lose weight. The women with lipedema in the study will have the option to use a whole-body suit that works like a pump and was designed to improve blood circulation in the body. The body suit is called Dermology and can be used before the HYPOXI exercise equipment but will be optional for the women in the study. The study is 16 weeks long for 20 women with lipedema. Ten women with lipedema will exercise with HYPOXI for 8 weeks then switch to a recumbent bike for the second 8 weeks. The other 10 women will exercise on a recumbent bike for 8 weeks then switch to HYPOXI for 8 weeks in the second half of the study. Baseline, mid-study, and end of study data will be collected including measurements of body composition and shape, a blood draw at the beginning, middle and end, and questionnaires. This study will be listed on clinicaltrials.gov for more information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Hypoxi Equipment

Experimental

干预措施: Hypoxi Equipment (Device)

Recumbent Bicycle

Active Comparator

干预措施: Recumbent Bicycle (Device)

结局指标

主要结局

Bioimpedence Scale Assessment of Total Body Water

时间窗: Change in total body water from baseline to end of study arm (8 weeks)

Total body water in kilograms

Bioimpedence Scale Assessment of Total Body Lean Body Mass

时间窗: Change in muscle mass from baseline to end of study arm (8 weeks)

Whole body muscle content in kilograms

Bioimpedence Scale Assessment of Total Body Fat Mass

时间窗: Change in fat mass from baseline to end of study arm (8 weeks)

Whole body fat mass in kilograms

次要结局

  • Resting energy expenditure(Change in resting energy expenditure from baseline to end of study arm (8 weeks))
  • Waist/Hip ratio(Change in waist/hip ratio from baseline to end of study arm (8 weeks))

研究者

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

KHerbst

Associate Professor

University of Arizona

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