Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
观察性的
注册 (估计的)
55
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Merve Aydın, MD
- 电话号码：2124445434
- 邮箱：merveay9702@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不适用
取样方法
非概率样本
研究人群
Patients with lipedema
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
2-Minute Step Test (2MST)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-Minute Walk Test (6MWT)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nurdan Paker, Prof、Istanbul Physical Medicine Rehabilitation Training and Research Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月10日
初级完成 (估计的)
2027年4月10日
研究完成 (估计的)
2027年4月10日
研究注册日期
首次提交
2026年8月4日
首先提交符合 QC 标准的
2026年8月4日
首次发布 (实际的)
2026年8月7日
研究记录更新
最后更新发布 (实际的)
2026年8月7日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.