- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853083
HYPOXI for Women With Lipedema
February 21, 2019 updated by: KHerbst, University of Arizona
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypoxi Equipment
|
Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
|
Active Comparator: Recumbent Bicycle
|
Recumbent bike is a piece of exercise equipment used as the comparison group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in muscle mass from baseline to end of study arm (8 weeks)
|
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
|
Change in fat mass from baseline to end of study arm (8 weeks)
|
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
|
Change in total body water from baseline to end of study arm (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in resting energy expenditure from baseline to end of study arm (8 weeks)
|
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
|
Change in waist/hip ratio from baseline to end of study arm (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2019
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
January 31, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1712140375
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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