HYPOXI for Women With Lipedema

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.

Study Overview

• Status: Unknown
• Conditions: Lipedema
• Intervention / Treatment: Device: Hypoxi Equipment; Device: Recumbent Bicycle

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen L Herbst, MD, PhD; Phone Number: 520-626-7689; Email: treatprogram@deptofmed.arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: 1712140375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No