Lipedema
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Inclusion criteria
* Clinically diagnosed with lipedema according to the Wold and Halk-Damstra criteria, stage 2 and above * Aged 18-65 years, female * No walking-limiting pathology * Willing to participate
Exclusion criteria
* Uncontrolled hypertension * Decompensated cardiac failure * Systemic, degenerative, neurological, rheumatological, or orthopedic disease affecting lower-extremity function * Lower-extremity surgery within the past 6 months * Peripheral artery disease causing vascular claudication * Severe psychiatric disorder (active psychosis, severe major depression) or cognitive impairment preventing compliance with test instructions * Neuromuscular disease * Pregnancy * Advanced-stage lipo-lymphedema severely restricting ambulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-Minute Step Test (2MST) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test (6MWT) | Baseline | Functional exercise capacity assessed by the total distance walked in 6 minutes (meters). Greater walking distance indicates better functional capacity and endurance. |
| Timed Up and Go Test (TUGT) | Baseline | 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. |
| Lower Extremity Functional Scale (LEFS) | Baseline | 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. |
| Visual Analog Scale (VAS) | Baseline | 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. |
Contacts
CONTACTMerve Aydın, MD
PRINCIPAL_INVESTIGATORNurdan Paker, Prof
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Outcome results
None listed