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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Merve Aydın, MD; Phone Number: 2124445434; Email: merveay9702@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with lipedema

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Nurdan Paker, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: Istftreah15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No