HYPOXI for Women With Lipedema

NCT03853083 | Unknown

• 1 other identifier: 1712140375
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Resting energy expenditure

  Change in resting energy expenditure from baseline to end of study arm (8 weeks)

• Waist/Hip ratio

  Change in waist/hip ratio from baseline to end of study arm (8 weeks)

Study Arms (2)

Hypoxi Equipment

EXPERIMENTAL

Device: Hypoxi Equipment

Recumbent Bicycle

ACTIVE COMPARATOR

Device: Recumbent Bicycle

Interventions

Hypoxi Equipment DEVICE

Using the Hypoxi exercise equipment to try and improve lipedema fat tissue

Hypoxi Equipment

Recumbent Bicycle DEVICE

Recumbent bike is a piece of exercise equipment used as the comparison group

Recumbent Bicycle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Karen L Herbst, MD, PhD

CONTACT

520-626-7689; treatprogram@deptofmed.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 25, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2021
• Last Updated: February 25, 2019

Record last verified: 2019-02