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HYPOXI for Women With Lipedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853083
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
KHerbst, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Lipedema Device: Hypoxi Equipment Device: Recumbent Bicycle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HYPOXI for Women With Lipedema
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

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




Primary Outcome Measures :
  1. Bioimpedence Scale Assessment of Total Body Lean Body Mass [ Time Frame: Change in muscle mass from baseline to end of study arm (8 weeks) ]
    Whole body muscle content in kilograms

  2. Bioimpedence Scale Assessment of Total Body Fat Mass [ Time Frame: Change in fat mass from baseline to end of study arm (8 weeks) ]
    Whole body fat mass in kilograms

  3. Bioimpedence Scale Assessment of Total Body Water [ Time Frame: Change in total body water from baseline to end of study arm (8 weeks) ]
    Total body water in kilograms


Secondary Outcome Measures :
  1. Resting energy expenditure [ Time Frame: Change in resting energy expenditure from baseline to end of study arm (8 weeks) ]
    Resting energy expenditure by MedGem Device in kcal/day

  2. Waist/Hip ratio [ Time Frame: Change in waist/hip ratio from baseline to end of study arm (8 weeks) ]
    Waist and hip measurements using a tape measure; this is a ratio with no units



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853083


Contacts
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Contact: Karen L Herbst, MD, PhD 520-626-7689 treatprogram@deptofmed.arizona.edu

Sponsors and Collaborators
University of Arizona
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Responsible Party: KHerbst, Associate Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT03853083    
Other Study ID Numbers: 1712140375
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lipedema
Connective Tissue Diseases