Trials / Unknown
UnknownNCT03853083
HYPOXI for Women With Lipedema
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hypoxi Equipment | Using the Hypoxi exercise equipment to try and improve lipedema fat tissue |
| DEVICE | Recumbent Bicycle | Recumbent bike is a piece of exercise equipment used as the comparison group |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2020-04-01
- Completion
- 2021-04-01
- First posted
- 2019-02-25
- Last updated
- 2019-02-25
Source: ClinicalTrials.gov record NCT03853083. Inclusion in this directory is not an endorsement.