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HYPOXI for Women With Lipedema

Primary Purpose

Lipedema

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypoxi Equipment
Recumbent Bicycle
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipedema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hypoxi Equipment

    Recumbent Bicycle

    Arm Description

    Outcomes

    Primary Outcome Measures

    Bioimpedence Scale Assessment of Total Body Lean Body Mass
    Whole body muscle content in kilograms
    Bioimpedence Scale Assessment of Total Body Fat Mass
    Whole body fat mass in kilograms
    Bioimpedence Scale Assessment of Total Body Water
    Total body water in kilograms

    Secondary Outcome Measures

    Resting energy expenditure
    Resting energy expenditure by MedGem Device in kcal/day
    Waist/Hip ratio
    Waist and hip measurements using a tape measure; this is a ratio with no units

    Full Information

    First Posted
    January 31, 2019
    Last Updated
    February 21, 2019
    Sponsor
    University of Arizona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03853083
    Brief Title
    HYPOXI for Women With Lipedema
    Official Title
    HYPOXI for Women With Lipedema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2020 (Anticipated)
    Study Completion Date
    April 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Arizona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypoxi Equipment
    Arm Type
    Experimental
    Arm Title
    Recumbent Bicycle
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Hypoxi Equipment
    Intervention Description
    Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
    Intervention Type
    Device
    Intervention Name(s)
    Recumbent Bicycle
    Intervention Description
    Recumbent bike is a piece of exercise equipment used as the comparison group
    Primary Outcome Measure Information:
    Title
    Bioimpedence Scale Assessment of Total Body Lean Body Mass
    Description
    Whole body muscle content in kilograms
    Time Frame
    Change in muscle mass from baseline to end of study arm (8 weeks)
    Title
    Bioimpedence Scale Assessment of Total Body Fat Mass
    Description
    Whole body fat mass in kilograms
    Time Frame
    Change in fat mass from baseline to end of study arm (8 weeks)
    Title
    Bioimpedence Scale Assessment of Total Body Water
    Description
    Total body water in kilograms
    Time Frame
    Change in total body water from baseline to end of study arm (8 weeks)
    Secondary Outcome Measure Information:
    Title
    Resting energy expenditure
    Description
    Resting energy expenditure by MedGem Device in kcal/day
    Time Frame
    Change in resting energy expenditure from baseline to end of study arm (8 weeks)
    Title
    Waist/Hip ratio
    Description
    Waist and hip measurements using a tape measure; this is a ratio with no units
    Time Frame
    Change in waist/hip ratio from baseline to end of study arm (8 weeks)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karen L Herbst, MD, PhD
    Phone
    520-626-7689
    Email
    treatprogram@deptofmed.arizona.edu

    12. IPD Sharing Statement

    Learn more about this trial

    HYPOXI for Women With Lipedema

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