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NCT Number: NCT07752017

Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 2-Minute Step Test (2MST)

    Time frame: 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 outcomes

  1. 6-Minute Walk Test (6MWT)

    Time frame: Baseline

    Functional exercise capacity assessed by the total distance walked in 6 minutes (meters). Greater walking distance indicates better functional capacity and endurance.

  2. Timed Up and Go Test (TUGT)

    Time frame: 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.

  3. Lower Extremity Functional Scale (LEFS)

    Time frame: 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.

  4. Visual Analog Scale (VAS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Aydın, MD

CONTACT

[email protected]

2124445434

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Construct Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema: A Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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