Clinical trial NCT03853083: HYPOXI for Women With Lipedema
Official title: HYPOXI for Women With Lipedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lipedema
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bioimpedence Scale Assessment of Total Body Lean Body Mass
timeFrame: Change in muscle mass from baseline to end of study arm (8 weeks)
measure: Bioimpedence Scale Assessment of Total Body Fat Mass
timeFrame: Change in fat mass from baseline to end of study arm (8 weeks)
measure: Bioimpedence Scale Assessment of Total Body Water
timeFrame: Change in total body water from baseline to end of study arm (8 weeks)
Secondary outcomes:
measure: Resting energy expenditure
timeFrame: Change in resting energy expenditure from baseline to end of study arm (8 weeks)
measure: Waist/Hip ratio
timeFrame: Change in waist/hip ratio from baseline to end of study arm (8 weeks)
Other outcomes:
Locations:
Study officials:
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