LipedemaNCT03853083
HYPOXI for Women With Lipedema
A study testing Hypoxi Equipment and Recumbent Bicycle in people with Lipedema, run by University of Arizona.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Hypoxi Equipment and Recumbent Bicycle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Lipedema
- Being tested
- Hypoxi Equipment, Recumbent Bicycle
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxi EquipmentDevice
Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
Recumbent BicycleDevice
Recumbent bike is a piece of exercise equipment used as the comparison group
| Study group | Role | What they receive |
|---|---|---|
| Hypoxi Equipment | Experimental | Not described Receives: Device: Hypoxi Equipment |
| Recumbent Bicycle | Active comparator | Not described Receives: Device: Recumbent Bicycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedence Scale Assessment of Total Body Lean Body Mass
Whole body muscle content in kilograms
Measured: Change in muscle mass from baseline to end of study arm (8 weeks)
Bioimpedence Scale Assessment of Total Body Fat Mass
Whole body fat mass in kilograms
Measured: Change in fat mass from baseline to end of study arm (8 weeks)
Bioimpedence Scale Assessment of Total Body Water
Total body water in kilograms
Measured: Change in total body water from baseline to end of study arm (8 weeks)
Secondary outcomes (2)
Resting energy expenditure
Resting energy expenditure by MedGem Device in kcal/day
Measured: Change in resting energy expenditure from baseline to end of study arm (8 weeks)
Waist/Hip ratio
Waist and hip measurements using a tape measure; this is a ratio with no units
Measured: Change in waist/hip ratio from baseline to end of study arm (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KHerbst, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853083
- Sponsor's protocol ID
- 1712140375
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPOXI for Women With Lipedema
- ClinicalTrials.gov ID
- NCT03853083
- Acronym / sponsor ID
- 1712140375
- Conditions
- Lipedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxi Equipment | Experimental | Device: Hypoxi Equipment |
| Recumbent Bicycle | Active comparator | Device: Recumbent Bicycle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- 18-65 years of age
- Lipedema any stage
- Weight < 300 lbs.
- Able to participate for 4 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxi EquipmentUsing the Hypoxi exercise equipment to try and improve lipedema fat tissue | Device | Hypoxi Equipment |
| Recumbent BicycleRecumbent bike is a piece of exercise equipment used as the comparison group | Device | Recumbent Bicycle |
Primary outcome
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
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
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
2 secondary outcomes
Resting energy expenditure
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxi Equipment and Recumbent Bicycle in people with Lipedema, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen L Herbst, MD, PhD (520-626-7689, treatprogram@deptofmed.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedence Scale Assessment of Total Body Lean Body Mass (time frame: Change in muscle mass from baseline to end of study arm (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.