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

NCT07752017 | Not Yet Recruiting

• 1 other identifier: Istftreah15
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 6-Minute Walk Test (6MWT)

  Baseline

• Timed Up and Go Test (TUGT)

  Baseline

• Lower Extremity Functional Scale (LEFS)

  Baseline

• Visual Analog Scale (VAS)

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lipedema

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nurdan Paker, Prof

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Aydın, MD

CONTACT

2124445434; merveay9702@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08