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CompletedNCT06866847Updated Feb 27, 2026

Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women With Lipedema

An observational study in Lipedema and Healthy, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

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Conditions studied

  • Lipedema
  • Healthy

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03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 42 observational studies indexed under Lipedema.

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Lead sponsor

Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with lipedema in Ankara/TURKEY

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women over the age of 18 diagnosed with lipedema

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: only one time

  2. 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.

    Time frame: only one time

  3. 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.

    Time frame: only one time

  4. 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.

    Time frame: only one time

  5. 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

    Time frame: only one time

  6. 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.

    Time frame: only one time

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Study locations

1 site
  • Gazi University Faculty of Health Sciences
    Ankara, Turkey (Türkiye)
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06866847
Lead sponsor
Gazi University
Responsible party
Ilke Keser (Prof. Dr., Gazi University) — Principal investigator
First posted
Mar 10, 2025
Start date
Jan 10, 2025
Primary completion
May 15, 2025
Completion
May 15, 2025
Last update
Feb 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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