HYPOXI for Women With Lipedema

Not Applicable

• Conditions: Lipedema
• Interventions: Device: Hypoxi Equipment; Device: Recumbent Bicycle

• Registration Number: NCT03853083
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-25
• Last Update Posted: 2019-02-25
• Study Start: 2019-04-01
• Primary Completion: 2020-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypoxi Equipment	Hypoxi Equipment	-
Recumbent Bicycle	Recumbent Bicycle	-

Primary Outcome Measures

Name	Time	Method
Bioimpedence Scale Assessment of Total Body Water	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	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	Change in fat mass from baseline to end of study arm (8 weeks)	Whole body fat mass in kilograms

Secondary Outcome Measures

Name	Time	Method
Resting energy expenditure	Change in resting energy expenditure from baseline to end of study arm (8 weeks)	Resting energy expenditure by MedGem Device in kcal/day
Waist/Hip ratio	Change in waist/hip ratio from baseline to end of study arm (8 weeks)	Waist and hip measurements using a tape measure; this is a ratio with no units