An observational study in Lipedema, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational
Lipedema is a chronic, progressive adipose tissue disorder that predominantly affects women and is characterized by symmetric, disproportionate subcutaneous fat accumulation in the lower extremities, pain, tenderness, and easy bruising. It is associated with reduced mobility and impaired functional capacity. Although the 2-Minute Step Test (2MST) is a practical, low-cost measure of functional capacity that requires no equipment or large space, its validity and reliability have not been investigated in patients with lipedema. The aim of this study is to evaluate the construct validity and test-retest reliability of the 2MST in women with lipedema.
This prospective, cross-sectional study will enroll 55 women diagnosed with lipedema (stage 2 and above) according to the Wold and Halk-Damstra criteria. Participants will undergo the 2-Minute Step Test (2MST), the 6-Minute Walk Test (6MWT), the Timed Up and Go Test (TUGT), the Visual Analog Scale (VAS) for pain, and the Lower Extremity Functional Scale (LEFS). Vital signs (blood pressure, oxygen saturation, heart rate) will be checked before testing. Tests will be administered in a fixed order (2MST, then 6MWT, then TUGT) with at least 30 minutes of rest between them, by the same examiner, at similar times of day. To assess test-retest reliability, the 2MST will be repeated after a 7-day interval by the same examiner. Reliability will be evaluated using the intraclass correlation coefficient (ICC) with 95% confidence intervals, standard error of measurement (SEM), and minimum detectable change (MDC95). Construct validity will be evaluated using Spearman correlation coefficients between the 2MST and the 6MWT, TUGT, LEFS, and VAS.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 55 is below the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.
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Patients with lipedema
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.
Exclusion Criteria:
2-Minute Step Test (2MST)
Functional exercise capacity assessed by the number of times the participant raises the knee to the required height during 2 minutes. Higher scores indicate better functional exercise capacity.
Time frame: Baseline
6-Minute Walk Test (6MWT)
Functional exercise capacity assessed by the total distance walked in 6 minutes (meters). Greater walking distance indicates better functional capacity and endurance.
Time frame: Baseline
Timed Up and Go Test (TUGT)
Functional mobility assessed by the time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down (seconds). Longer completion times indicate poorer functional mobility and balance.
Time frame: Baseline
Lower Extremity Functional Scale (LEFS)
Self-reported lower extremity function assessed using a 20-item questionnaire with a total score ranging from 0 to 80. Higher scores indicate better lower extremity function and less disability.
Time frame: Baseline
Visual Analog Scale (VAS)
Pain intensity assessed using a 100-mm visual analog scale ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame: Baseline
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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