- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07725146
Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire (RapprichTR)
Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Canan Şanal, Assoc. Prof.
- Phone Number: +90 533 138 10 32
- Email: canansanal@hotmail.com
Study Contact Backup
- Name: M. Selim Eryılmaz, Res. Asst.
Study Locations
-
-
Kadıköy
-
Istanbul, Kadıköy, Turkey (Türkiye)
- Recruiting
- Sultan 2. Abdülhamid Han Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.
-
Contact:
- Feyza Nur Yücel, Assoc. Prof.
- Phone Number: +905385577059
- Email: dr.fny28@gmail.com
-
Contact:
- İrem Lazkan, Res. Asst.
- Phone Number: +90534 92 63 640
-
-
Pendik
-
Istanbul, Pendik, Turkey (Türkiye), 34899
- Recruiting
- Marmara University Pendik Training and Research Hospital, Physical Medicine and Rehabilitation Department, Istanbul, Turkey.
-
Contact:
- Selim Eryılmaz
- Phone Number: 05424848329
- Email: selimerylmz@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients aged 18-75.
- Diagnosed with lipedema by a clinician.
- Willingness to participate and sign the informed consent form.
Exclusion Criteria:
- Positive Stemmer sign or presence of advanced-stage lymphedema.
- Diagnosis of Heart Failure.
- Chronic Kidney Disease.
- Pregnancy.
- BMI > 50 kg/m².
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stage I Lipedema
60 female patients diagnosed with Stage I lipedema
|
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
|
|
Stage II Lipedema
60 female patients diagnosed with Stage II lipedema
|
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
|
|
Stage III Lipedema
60 female patients diagnosed with Stage III
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internal Consistency (Cronbach's Alpha)
Time Frame: At baseline (Day 0).
|
Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.
|
At baseline (Day 0).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-Retest Reliability (ICC)
Time Frame: Baseline and 14 days
|
Agreement between two measurements taken 14 days apart in a subgroup of 40 patients.
|
Baseline and 14 days
|
|
Criterion Validity (Correlation with SF-36).
Time Frame: At baseline (Day 0)
|
Correlation between Rapprich questionnaire scores and the 8 sub-dimensions of the SF-36 quality of life scale.
|
At baseline (Day 0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine
Publications and helpful links
General Publications
- Mortada H, Alhithlool AW, AlBattal NZ, Shetty RK, Al-Mekhlafi GA, Hong JP, Alshomer F. Lipedema: Clinical Features, Diagnosis, and Management. Arch Plast Surg. 2025 May 15;52(3):185-196. doi: 10.1055/a-2530-5875. eCollection 2025 May.
- Amato ACM, Amato FCM, Benitti DA, Dos Santos RV. Translation, cultural adaptation, and validation of a lipedema symptoms questionnaire. J Vasc Bras. 2020 Aug 31;19:e20200049. doi: 10.1590/1677-5449.200049.
- van la Parra RFD, Deconinck C, Pirson G, Servaes M, Fosseprez P. Lipedema: What we don't know. J Plast Reconstr Aesthet Surg. 2023 Sep;84:302-312. doi: 10.1016/j.bjps.2023.05.056. Epub 2023 May 30.
- Rapprich S, Dingler A, Podda M. Liposuction is an effective treatment for lipedema-results of a study with 25 patients. J Dtsch Dermatol Ges. 2011 Jan;9(1):33-40. doi: 10.1111/j.1610-0387.2010.07504.x. Epub 2010 Sep 7. English, German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Connective Tissue Diseases
- Skin and Connective Tissue Diseases
- Lipedema
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Behavior Control
- Immobilization
- Surveys and Questionnaires
- Restraint, Physical
Other Study ID Numbers
- RapprichTR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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