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Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire

ConditionLipedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18-75.

Diagnosed with lipedema by a clinician.

Willingness to participate and sign the informed consent form.

Disqualifiers

Positive Stemmer sign or presence of advanced-stage lymphedema.

Diagnosis of Heart Failure.

Chronic Kidney Disease.

Pregnancy.

Trial population

The study population consists of 180 female patients aged 18 to 75 years diagnosed with Stage I, II, or III lipedema, recruited from the Physical Medicine and Rehabilitation clinics of the participating hospitals.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    Turkish version of Rapprich Lipedema Symptomatic Assessment Questionnaire: A 15-item scale used to evaluate the severity of lipedema symptoms (such as pain, tension, tenderness, bruising, and heaviness) on a 0-10 point rating scale. Short Form-36 (SF-36) Health Survey: A widely used, validated scale to assess the general health status and quality of life across eight sub-dimensions, used in this study for criterion validity

  • Physical Examination and Functional Testing

    Other intervention

    * Anthropometric and Vital Measurements: Recording of demographic data (age, height, weight, BMI), as well as arterial blood pressure and pulse rate. * Lipedema-Specific Assessment: Clinical determination of the lipedema stage (Stages I-III) and type (Types I-V). * Morphometric Measurements: Measurement of waist and hip circumferences (for waist-to-hip ratio) and actual leg length. * Lower Extremity Volume Calculation: Circular circumference measurements taken at 4 cm intervals starting from the ankle to calculate the total volume of both lower extremities. * 6-Minute Walk Test (6MWT): A functional test to evaluate the total walking distance and heart rate response, assessing the patient's functional capacity.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Stage I Lipedema2 interventions
Group B: Stage II Lipedema2 interventions
Group C: Stage III Lipedema2 interventions

Trial outcomes

Primary outcomes

1

Internal Consistency (Cronbach's Alpha)

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

Time frame
At baseline (Day 0).

Secondary outcomes

1

Test-Retest Reliability (ICC)

Agreement between two measurements taken 14 days apart in a subgroup of 40 patients.

Time frame
Baseline and 14 days
2

Criterion Validity (Correlation with SF-36).

Correlation between Rapprich questionnaire scores and the 8 sub-dimensions of the SF-36 quality of life scale.

Time frame
At baseline (Day 0)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Source ClinicalTrials.gov
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