Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema (NCT07752017) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
55 participantsStarted 2026-08-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
2-Minute Step Test (2MST)
Timeframe: Baseline
Trial details
NCT IDNCT07752017
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital