HYPOXI for Women With Lipedema

Lipedema Clinical Trial

Official title:

HYPOXI for Women With Lipedema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853083
• Other study ID #: 1712140375
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2019
• Source: University of Arizona
• Contact: Karen L Herbst, MD, PhD
• Phone: 520-626-7689
• Email: treatprogram[@]deptofmed.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipedema

Intervention

Device:
• Hypoxi Equipment
Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
• Recumbent Bicycle
Recumbent bike is a piece of exercise equipment used as the comparison group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)