LipedemaRapprichTRNCT07725146
Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire
An observational study of Lipedema, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Questionnaires and Physical Examination and Functional Testing
- How many people
- 180 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Jul 2026to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Female patients aged 18-75.
- Diagnosed with lipedema by a clinician.
- Willingness to participate and sign the informed consent form.
Who cannot join
- Positive Stemmer sign or presence of advanced-stage lymphedema.
- Diagnosis of Heart Failure.
- Chronic Kidney Disease.
- Pregnancy.
- BMI > 50 kg/m².
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
M. Selim Eryılmaz, Res. Asst. contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Sultan 2. Abdülhamid Han Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.
Istanbul, Kadıköy
Feyza Nur Yücel, Assoc. Prof., +905385577059, dr.fny28@gmail.com
İrem Lazkan, Res. Asst., +90534 92 63 640
- Recruiting
Marmara University Pendik Training and Research Hospital, Physical Medicine and Rehabilitation Department, Istanbul, Turkey.
Istanbul, Pendik, 34899
Selim Eryılmaz, 05424848329, selimerylmz@gmail.com
About this study
Official title: Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire
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.
Read the 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.
- Conditions
- Lipedema
- Being tested
- Questionnaires, Physical Examination and Functional Testing
- Keywords
- Lipedema, Rapprich Questionnaire, Symptom Assessment, Turkish, Cultural Adaptation, Adipose Tissue Diseases, Quality of Life
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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 TestingOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Stage I Lipedema | 60 female patients diagnosed with Stage I lipedema Receives: Other: Questionnaires; Other: Physical Examination and Functional Testing | |
| Stage II Lipedema | 60 female patients diagnosed with Stage II lipedema Receives: Other: Questionnaires; Other: Physical Examination and Functional Testing | |
| Stage III Lipedema | 60 female patients diagnosed with Stage III Receives: Other: Questionnaires; Other: Physical Examination and Functional Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency (Cronbach's Alpha)
Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.
Measured: At baseline (Day 0).
Secondary outcomes (2)
Test-Retest Reliability (ICC)
Agreement between two measurements taken 14 days apart in a subgroup of 40 patients.
Measured: Baseline and 14 days
Criterion Validity (Correlation with SF-36).
Correlation between Rapprich questionnaire scores and the 8 sub-dimensions of the SF-36 quality of life scale.
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start17 Jul 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan Şanal, Assoc. Prof., Principal investigator, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725146
- Sponsor's protocol ID
- RapprichTR
- Acronym
- RapprichTR
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40386000Amato 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.
PubMed 34178078van 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.
PubMed 37390539Rapprich 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.
PubMed 21166777
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire
- ClinicalTrials.gov ID
- NCT07725146
- Acronym / sponsor ID
- RapprichTR / RapprichTR
- Conditions
- Lipedema
- Keywords
- Lipedema, Rapprich Questionnaire, Symptom Assessment, Turkish, Cultural Adaptation, Adipose Tissue Diseases, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage I Lipedema | – | Other: Questionnaires, Other: Physical Examination and Functional Testing60 female patients diagnosed with Stage I lipedema |
| Stage II Lipedema | – | Other: Questionnaires, Other: Physical Examination and Functional Testing60 female patients diagnosed with Stage II lipedema |
| Stage III Lipedema | – | Other: Questionnaires, Other: Physical Examination and Functional Testing60 female patients diagnosed with Stage III |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Female patients aged 18-75.
- Diagnosed with lipedema by a clinician.
- Willingness to participate and sign the informed consent form.
Key exclusion criteria (5 listed)
- Positive Stemmer sign or presence of advanced-stage lymphedema.
- Diagnosis of Heart Failure.
- Chronic Kidney Disease.
- Pregnancy.
- BMI > 50 kg/m².
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesTurkish 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 | Other | Stage I Lipedema, Stage II Lipedema, Stage III Lipedema |
| Physical Examination and Functional Testing* 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. | Other | Stage I Lipedema, Stage II Lipedema, Stage III Lipedema |
Primary outcome
Internal Consistency (Cronbach's Alpha)
Time frame: At baseline (Day 0).
Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.
2 secondary outcomes
Test-Retest Reliability (ICC)
Time frame: Baseline and 14 days
Criterion Validity (Correlation with SF-36).
Time frame: At baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 40386000Mortada 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.
- Background: PubMed 34178078Amato 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.
- Background: PubMed 37390539van 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.
- Background: PubMed 21166777Rapprich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
M. Selim Eryılmaz, Res. Asst. contact
Canan Şanal, Assoc. Prof. principal investigator
Marmara University Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Canan Şanal, Assoc. Prof. (+90 533 138 10 32, canansanal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency (Cronbach's Alpha) (time frame: At baseline (Day 0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07725146, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.