Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lipedema. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construct Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema: A Cross-Sectional Study
Overview
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.
Primary outcome measures
- 2-Minute Step Test (2MST) [Time frame: Baseline]
Secondary outcome measures (4)
- 6-Minute Walk Test (6MWT) [Time frame: Baseline]
- Timed Up and Go Test (TUGT) [Time frame: Baseline]
- Lower Extremity Functional Scale (LEFS) [Time frame: Baseline]
- Visual Analog Scale (VAS) [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07752017 · Istftreah15