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

ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Uncontrolled hypertension

Decompensated cardiac failure

Systemic, degenerative, neurological, rheumatological, or orthopedic disease affecting lower-extremity function

Lower-extremity surgery within the past 6 months

Trial population

Patients with lipedema

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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