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

4. november 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Lipødem

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Merve Aydın, MD
Telefonnummer: 2124445434
E-mail: merveay9702@gmail.com

Studiesteder

Tyrkiet (Türkiye)
- Bahcelievler
  - Istanbul, Bahcelievler, Tyrkiet (Türkiye), 34100
    - Rekruttering
    - İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
    - Kontakt:
      
      Merve Aydin, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with lipedema

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: CASE_ONLY
Tidsperspektiver: CROSS_SECTIONAL

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
2-Minute Step Test (2MST) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
6-Minute Walk Test (6MWT) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Efterforskere

Ledende efterforsker: Nurdan Paker, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. august 2026

Primær færdiggørelse (Anslået)

10. april 2027

Studieafslutning (Anslået)

10. april 2027

Datoer for studieregistrering

Først indsendt

4. august 2026

Først indsendt, der opfyldte QC-kriterier