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

November 4, 2026 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Merve Aydın, MD
Phone Number: 2124445434
Email: merveay9702@gmail.com

Study Locations

Turkey (Türkiye)
- Bahcelievler
  - Istanbul, Bahcelievler, Turkey (Türkiye), 34100
    - Recruiting
    - İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
    - Contact:
      
      Merve Aydin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: CASE_ONLY
Time Perspectives: CROSS_SECTIONAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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