LipedemaNCT06866847
Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women With Lipedema
An observational study of Lipedema and Healthy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. Lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 15 May 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with lipedema in Ankara/TURKEY
Who may be able to join
- Women over the age of 18 diagnosed with lipedema
Who cannot join
- Having cardiovascular, orthopedic and/or neurological problems that may affect physical capacity
- Having diseases such as heart failure, kidney failure that may cause general or localized edema
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences
Ankara
About this study
Official title: Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women With Lipedema: A Case-Control Study
Lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. Lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. The aim of this study is to evaluate muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema parameters in individuals diagnosed with lipedema and to compare them with individuals without lipedema. Volunteer women aged 18 years and older with lipedema (study group) and without lipedema (control group) will be included in the study. After recording the demographic information of the patients, lower extremity muscle strength will be assessed with the K-force handheld dynamometer, lower extremity muscle endurance with the 30 Second Sit-to-Stand Test, lower extremity function with the Lower Extremity Functional Scale, aerobic capacity with the 6-Minute Walking Test, pressure pain threshold with the Baseline algometer, and edema with the moisturemeter. Data from the study and control groups will be recorded in the SPSS program and compared using the appropriate statistical method.
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Women diagnosed with lipedema | |
| control group | Women over the age of 18 who do not have any cardiovascular, orthopedic and/or neurological problems that may affect physical capacity and who do not have diseases such as heart failure or renal failure that may cause general or localized edema. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Muscle Strength
The individuals' gluteus maximus, hip flexor, abductor and knee extensor strength in their dominant extremities will be assessed with a K-force handheld dynamometer (Montpellier, France). In the assessment, the individual will be positioned in a prone position for the gluteus maximus muscle test, in a sitting position for the hip flexor and extensor muscles test and in a side-lying position for the hip abductors test, and the dynamometer will be stabilized as specified in the K-Force manual, and the individual will be asked to apply maximum effort against the dynamometer. The measurements will be repeated 3 times and the maximum value will be recorded in kg.
Measured: only one time
Assessment of Lower Extremity Muscle Endurance
Lower extremity muscle endurance will be assessed with the 30-Second Sit-Stand Test. In this test, the individual will sit on a chair with their back supported. The individual will then be asked to stand up and sit down again with their back straight for 30 seconds, and the number of times this cycle is repeated within 30 seconds will be recorded.
Measured: only one time
Assessment of Lower Extremity Function
It will be evaluated with the Lower Extremity Functional Scale. The Lower Extremity Functional Scale is a questionnaire developed to evaluate individuals' lower extremity functions, abilities and activity limitations. Scoring is between 0-80. Higher scores indicate better function. It is based on the individual's self-assessment and personal statement. The Turkish version of the scale was developed by Çankaya et al. and reported to be valid and reliable.
Measured: only one time
Assessment of Aerobic Capacity
It will be evaluated with the 6 Minute Walking Test. During this test, the individual is asked to walk as fast as he can in a 30-meter corridor for 6 minutes and the total walking distance is recorded in meters.
Measured: only one time
Assessment of Pressure Pain Threshold
A digital algometer (Baseline) will be used to assess the pain threshold. The algometer will be calibrated before the assessment. A 1 cm2 probe will be used for the measurements. The midpoint of the quadriceps and tibia will be marked before the measurement. The measurement will be repeated 3 times at 5-second intervals and the average value will be recorded. The algometer will be placed at a right angle to each point, participants will be asked to report the presence of pain by saying "yes" and the value on the device will be recorded as the pain threshold when they first feel pain at the point of touch. There will be a 5-second interval between measurements
Measured: only one time
Assessment of Edema
Local tissue water percentage of individuals will be measured with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device. This device calculates the percentage of water under the skin by touching the reference points from the skin surface. The reference points were determined as the medial of 35 cm above the heel (calf) on both legs, the medial of 3 cm proximal to the patella (medial knee) and the lateral of 20 cm above the line drawn from 3 cm proximal to the patella to the SIAS (lateral hip) (6). 3 measurements will be made for each reference point and the average of these measurements will be recorded.
Measured: only one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 Jan 2025
- Primary completion15 May 2025
- Study completion15 May 2025
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 Gazi UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866847
- Sponsor's protocol ID
- Lipedema/Haspolat M
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women With Lipedema: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06866847
- Acronym / sponsor ID
- Lipedema/Haspolat M
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 10 Mar 2025 (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.
Lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. Lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. The aim of this study is to evaluate muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema parameters in individuals diagnosed with lipedema and to compare them with individuals without lipedema. Volunteer women aged 18 years and older with lipedema (study group) and without lipedema (control group) will be included in the study. After recording the demographic information of the patients, lower extremity muscle strength will be assessed with the K-force handheld dynamometer, lower extremity muscle endurance with the 30 Second Sit-to-Stand Test, lower extremity function with the Lower Extremity Functional Scale, aerobic capacity with the 6-Minute Walking Test, pressure pain threshold with the Baseline algometer, and edema with the moisturemeter. Data from the study and control groups will be recorded in the SPSS program and compared using the appropriate statistical method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Women diagnosed with lipedema |
| control group | – | –Women over the age of 18 who do not have any cardiovascular, orthopedic and/or neurological problems that may affect physical capacity and who do not have diseases such as heart failure or renal failure that may cause general or localized edema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with lipedema in Ankara/TURKEY
Key inclusion criteria (1 listed)
- Women over the age of 18 diagnosed with lipedema
Key exclusion criteria (2 listed)
- Having cardiovascular, orthopedic and/or neurological problems that may affect physical capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Muscle Strength
Time frame: only one time
The individuals' gluteus maximus, hip flexor, abductor and knee extensor strength in their dominant extremities will be assessed with a K-force handheld dynamometer (Montpellier, France). In the assessment, the individual will be positioned in a prone position for the gluteus maximus muscle test, in a sitting position for the hip flexor and extensor muscles test and in a side-lying position for the hip abductors test, and the dynamometer will be stabilized as specified in the K-Force manual, and the individual will be asked to apply maximum effort against the dynamometer. The measurements will be repeated 3 times and the maximum value will be recorded in kg.
Assessment of Lower Extremity Muscle Endurance
Time frame: only one time
Lower extremity muscle endurance will be assessed with the 30-Second Sit-Stand Test. In this test, the individual will sit on a chair with their back supported. The individual will then be asked to stand up and sit down again with their back straight for 30 seconds, and the number of times this cycle is repeated within 30 seconds will be recorded.
Assessment of Lower Extremity Function
Time frame: only one time
It will be evaluated with the Lower Extremity Functional Scale. The Lower Extremity Functional Scale is a questionnaire developed to evaluate individuals' lower extremity functions, abilities and activity limitations. Scoring is between 0-80. Higher scores indicate better function. It is based on the individual's self-assessment and personal statement. The Turkish version of the scale was developed by Çankaya et al. and reported to be valid and reliable.
Assessment of Aerobic Capacity
Time frame: only one time
It will be evaluated with the 6 Minute Walking Test. During this test, the individual is asked to walk as fast as he can in a 30-meter corridor for 6 minutes and the total walking distance is recorded in meters.
Assessment of Pressure Pain Threshold
Time frame: only one time
A digital algometer (Baseline) will be used to assess the pain threshold. The algometer will be calibrated before the assessment. A 1 cm2 probe will be used for the measurements. The midpoint of the quadriceps and tibia will be marked before the measurement. The measurement will be repeated 3 times at 5-second intervals and the average value will be recorded. The algometer will be placed at a right angle to each point, participants will be asked to report the presence of pain by saying "yes" and the value on the device will be recorded as the pain threshold when they first feel pain at the point of touch. There will be a 5-second interval between measurements
Assessment of Edema
Time frame: only one time
Local tissue water percentage of individuals will be measured with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device. This device calculates the percentage of water under the skin by touching the reference points from the skin surface. The reference points were determined as the medial of 35 cm above the heel (calf) on both legs, the medial of 3 cm proximal to the patella (medial knee) and the lateral of 20 cm above the line drawn from 3 cm proximal to the patella to the SIAS (lateral hip) (6). 3 measurements will be made for each reference point and the average of these measurements will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Healthy, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Muscle Strength (time frame: only one time). The study lists 6 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 27 Feb 2026.