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
About this trial
This is an interventional treatment trial for Lipedema
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
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
NCT ID
NCT03853083
First Posted
January 31, 2019
Last Updated
February 21, 2019
Sponsor
University of Arizona
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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