HYPOXI for Women With Lipedema

Study Overview
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Brief Summary
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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.

Official Title
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HYPOXI for Women With Lipedema

Conditions
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Lipedema

Intervention / Treatment
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* Device: Hypoxi Equipment
* Device: Recumbent Bicycle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Female 18-65 years of age Lipedema any stage Weight < 300 lbs. Able to participate for 4 months Self-reported weight stable Able to use Hypoxi equipment & recumbent bike Able to undergo baseline, mid- and end-study in Tucson. Exclusion Criteria Hip width > 30 inches (76.2 cm) Waist width > 46 inches Pregnancy Use of weight loss medication within 3 months of the study History of myocardial infarction New York Heart Association Functional Class II or above congestive heart failure Sustained tachycardia above calculated maximum heart rate limit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypoxi Equipment<br> | Device: Hypoxi Equipment<br>* Using the Hypoxi exercise equipment to try and improve lipedema fat tissue<br>|
| Active Comparator: Recumbent Bicycle<br> | Device: Recumbent Bicycle<br>* Recumbent bike is a piece of exercise equipment used as the comparison group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioimpedence Scale Assessment of Total Body Lean Body Mass | Whole body muscle content in kilograms | Change in muscle mass from baseline to end of study arm (8 weeks) | 
| Bioimpedence Scale Assessment of Total Body Fat Mass | Whole body fat mass in kilograms | Change in fat mass from baseline to end of study arm (8 weeks) | 
| Bioimpedence Scale Assessment of Total Body Water | Total body water in kilograms | Change in total body water from baseline to end of study arm (8 weeks) | 

Secondary Outcome Measures

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