- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866847
Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women With Lipedema
February 26, 2026 updated by: Ilke Keser, Gazi University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey (Türkiye)
- Gazi University Faculty of Health Sciences
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Women with lipedema in Ankara/TURKEY
Description
Inclusion Criteria:
- Women over the age of 18 diagnosed with lipedema
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
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
Cohorts and Interventions
Group / Cohort |
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study group
Women diagnosed with lipedema
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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 is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of Muscle Strength
Time Frame: only one time
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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.
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only one time
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Assessment of Lower Extremity Muscle Endurance
Time Frame: only one time
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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.
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only one time
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Assessment of Lower Extremity Function
Time Frame: only one time
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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.
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only one time
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Assessment of Aerobic Capacity
Time Frame: only one time
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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.
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only one time
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Assessment of Pressure Pain Threshold
Time Frame: only one time
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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
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only one time
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Assessment of Edema
Time Frame: only one time
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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.
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only one time
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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 (Actual)
January 10, 2025
Primary Completion (Actual)
May 15, 2025
Study Completion (Actual)
May 15, 2025
Study Registration Dates
First Submitted
March 4, 2025
First Submitted That Met QC Criteria
March 4, 2025
First Posted (Actual)
March 10, 2025
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 26, 2026
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lipedema/Haspolat M
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.