跳至主要内容
临床试验/NCT07725146
NCT07725146招募中不适用

Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire

Marmara University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Internal Consistency (Cronbach's Alpha)

研究概览

简要总结

Lipedema is a chronic disease characterized by abnormal fat accumulation, primarily in the lower extremities, affecting women. This study aims to evaluate the validity and reliability of the Turkish version of the Rapprich Lipedema Symptomatic Assessment Questionnaire, which was originally developed by Rapprich et al. in 2010. Since a validated Turkish version is currently unavailable, this research will provide a standardized tool for clinicians to assess symptomatic severity in Turkish-speaking lipedema patients.

详细描述

This cross-sectional study will involve 180 female participants diagnosed with lipedema (Stages I, II, and III). Participants will be recruited from the Physical Medicine and Rehabilitation clinics of Marmara University and Sultan 2. Abdülhamid Han Training and Research Hospital.

Assessments will include:

  • Demographic data (age, BMI).
  • Physical examinations (waist-hip ratio, limb circumference, and volume calculations).
  • Functional testing (6-minute walk test).
  • The Turkish version of the Rapprich Lipedema Symptomatic Assessment -Questionnaire (15 items scored 0-10).
  • The SF-36 Health Survey for criterion validity.

Statistical analysis will include Cronbach's alpha for internal consistency, Intraclass Correlation Coefficient (ICC) for test-retest reliability (14-day interval), and Exploratory/Confirmatory Factor Analysis for construct validity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18-
  • Diagnosed with lipedema by a clinician.
  • Willingness to participate and sign the informed consent form.

排除标准

  • Positive Stemmer sign or presence of advanced-stage lymphedema.
  • Diagnosis of Heart Failure.
  • Chronic Kidney Disease.
  • Pregnancy.
  • BMI > 50 kg/m².

研究组 & 干预措施

Stage III Lipedema

60 female patients diagnosed with Stage III

干预措施: Questionnaires (Other)

Stage III Lipedema

60 female patients diagnosed with Stage III

干预措施: Physical Examination and Functional Testing (Other)

Stage I Lipedema

60 female patients diagnosed with Stage I lipedema

干预措施: Questionnaires (Other)

Stage I Lipedema

60 female patients diagnosed with Stage I lipedema

干预措施: Physical Examination and Functional Testing (Other)

Stage II Lipedema

60 female patients diagnosed with Stage II lipedema

干预措施: Questionnaires (Other)

Stage II Lipedema

60 female patients diagnosed with Stage II lipedema

干预措施: Physical Examination and Functional Testing (Other)

结局指标

主要结局

Internal Consistency (Cronbach's Alpha)

时间窗: At baseline (Day 0).

Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.

次要结局

  • Test-Retest Reliability (ICC)(Baseline and 14 days)
  • Criterion Validity (Correlation with SF-36).(At baseline (Day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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