LipedemaDASI-LIPNCT07803913
Validity and Reliability of the Turkish Duke Activity Status Index in Women With Lipedema
An observational study of Lipedema, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the validity and reliability of the Turkish version of the Duke Activity Status Index (DASI) in women with lipedema. DASI is a 12-item questionnaire designed to assess functional capacity based on activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Duke Activity Status Index (DASI)
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2026to 30 Oct 2026
- How long will I take part?
- 7 Days
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult women diagnosed with lipedema who meet the predefined eligibility criteria. Participants will be recruited from individuals evaluated for lipedema and referred for physiotherapy assessment. Eligible participants who voluntarily agree to participate and provide informed consent will be enrolled in the study. The study population will be used to evaluate the validity and test-retest reliability of the Turkish version of the Duke Activity Status Index (DASI).
Who may be able to join
- Female sex.
- Aged 18 to <65 years.
- Diagnosis of lipedema.
- No participation in a physiotherapy program within the previous 3 months.
- No history of liposuction surgery.
- Not currently following a weight-loss diet.
- No change in body weight greater than 10% within the previous 6 months.
- Willing to participate in the study and able to provide informed consent.
Who cannot join
- Severe visual or cognitive impairment.
- Severe cardiovascular disease.
- Musculoskeletal disorders or injuries affecting the lower extremities, including osteoarthritis, contracture, or osteoporosis, that may interfere with study assessments.
- Skin conditions that may interfere with the assessments, such as pressure ulcers.
- Uncontrolled endocrine disorders, including type 1 or type 2 diabetes mellitus or hypothyroidism.
- Obesity secondary to endocrine disorders or medication-induced obesity.
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- Use of estrogen-progestin therapy within the previous 2 months.
- Pregnancy or a positive pregnancy test.
- Breastfeeding.
- Concurrent participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Eyupsultan, 34250
Merve SEVİNC GUNDUZ, MSc, 05312991841, mrvsevinccc@gmail.com
About this study
Official title: Validity and Reliability Study of the Turkish Version of the Duke Activity Status Index in Patients With Lipedema
This study aims to evaluate the validity and reliability of the Turkish version of the Duke Activity Status Index (DASI) in women with lipedema. DASI is a 12-item questionnaire designed to assess functional capacity based on activities of daily living. The study will examine the test-retest reliability and internal consistency of the Turkish DASI and investigate its validity by examining its relationships with functional exercise capacity, lower extremity function, and health-related quality of life. The findings are expected to determine whether the Turkish DASI is a valid and reliable tool for assessing functional capacity in women with lipedema.
Read the detailed description
Lipedema is a chronic disorder characterized by disproportionate and symmetrical accumulation of subcutaneous adipose tissue, predominantly affecting the lower extremities. Symptoms such as pain, heaviness, fatigue, and reduced mobility may adversely affect physical functioning and activities of daily living. Therefore, assessment of functional capacity is an important component of the clinical evaluation of individuals with lipedema.
The Duke Activity Status Index (DASI) is a 12-item self-administered questionnaire that evaluates functional capacity through activities of daily living. The total score ranges from 0 to 58.2, with higher scores indicating better functional capacity. The DASI score can also be used to estimate peak oxygen consumption (VO2 peak).
This methodological study is designed to investigate the psychometric properties of the Turkish version of the DASI in women diagnosed with lipedema. Participants will undergo assessments including the DASI, Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). The DASI will be administered again after a 7-day interval to evaluate test-retest reliability.
Test-retest reliability and internal consistency of the Turkish DASI will be examined. Construct validity will be evaluated by examining the relationships between DASI scores and measures of functional exercise capacity, lower extremity function, and health-related quality of life. The study aims to determine whether the Turkish version of the DASI provides a valid, reliable, and practical instrument for assessing functional capacity in women with lipedema.
- Conditions
- Lipedema
- Being tested
- Duke Activity Status Index (DASI)
- Keywords
- Duke Activity Status Index, DASI, Functional Capacity, Validity, Reliability, Test-Retest Reliability, Lower Extremity Function, Exercise Capacity, 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.
Duke Activity Status Index (DASI)Diagnostic test
The Duke Activity Status Index (DASI) is a 12-item self-administered questionnaire used to assess functional capacity based on activities of daily living. The total score ranges from 0 to 58.2, with higher scores indicating better functional capacity. The Turkish version of the DASI will be administered at the initial assessment and repeated after 7 days to evaluate test-retest reliability.
| Study group | Role | What they receive |
|---|---|---|
| Women With Lipedema | Women diagnosed with lipedema who meet the eligibility criteria will be included in this study. Participants will undergo assessments of functional capacity, lower extremity function, and health-related quality of life using the Duke Activity Status Index (DASI), Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). The DASI will be administered again after 7 days to assess test-retest reliability. Receives: Diagnostic Test: Duke Activity Status Index (DASI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-Retest Reliability of the Turkish Duke Activity Status Index
Test-retest reliability of the Turkish version of the Duke Activity Status Index (DASI) will be evaluated by administering the questionnaire twice, with a 7-day interval. The DASI consists of 12 items assessing functional capacity during activities of daily living, with a total score ranging from 0 to 58.2; higher scores indicate better functional capacity. Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC).
Measured: Baseline and 7 days
Construct Validity of the Turkish Duke Activity Status Index
Construct validity of the Turkish DASI will be evaluated by examining the relationships between DASI scores and the Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). Correlation analyses will be used to determine the strength and direction of the relationships between these measures.
Measured: Baseline-7 days
Secondary outcomes (3)
Functional Exercise Capacity - Six-Minute Walk Test
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible along a 30-meter corridor for 6 minutes. The total distance walked will be recorded in meters, with a greater distance indicating better functional exercise capacity.
Measured: Baseline-7 days
Lower Extremity Functional Status - LEFS
Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items assessing difficulty in performing daily activities. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 80. Higher scores indicate better lower extremity function.
Measured: Baseline-7 days
Health-Related Quality of Life - SF-36
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight domains of health-related quality of life. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start25 Aug 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve SEVINC GUNDUZ, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803913
- Sponsor's protocol ID
- 2026/406
- Other IDs
- 2026/406
- Acronym
- DASI-LIP
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because data sharing is not included in the current study protocol or informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of the Turkish Version of the Duke Activity Status Index in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT07803913
- Acronym / sponsor ID
- DASI-LIP / 2026/406
- Conditions
- Lipedema
- Keywords
- Duke Activity Status Index, DASI, Functional Capacity, Validity, Reliability, Test-Retest Reliability, Lower Extremity Function, Exercise Capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 4 Sep 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.
This study aims to evaluate the validity and reliability of the Turkish version of the Duke Activity Status Index (DASI) in women with lipedema. DASI is a 12-item questionnaire designed to assess functional capacity based on activities of daily living. The study will examine the test-retest reliability and internal consistency of the Turkish DASI and investigate its validity by examining its relationships with functional exercise capacity, lower extremity function, and health-related quality of life. The findings are expected to determine whether the Turkish DASI is a valid and reliable tool for assessing functional capacity in women with lipedema.
Detailed description
Lipedema is a chronic disorder characterized by disproportionate and symmetrical accumulation of subcutaneous adipose tissue, predominantly affecting the lower extremities. Symptoms such as pain, heaviness, fatigue, and reduced mobility may adversely affect physical functioning and activities of daily living. Therefore, assessment of functional capacity is an important component of the clinical evaluation of individuals with lipedema.
The Duke Activity Status Index (DASI) is a 12-item self-administered questionnaire that evaluates functional capacity through activities of daily living. The total score ranges from 0 to 58.2, with higher scores indicating better functional capacity. The DASI score can also be used to estimate peak oxygen consumption (VO2 peak).
This methodological study is designed to investigate the psychometric properties of the Turkish version of the DASI in women diagnosed with lipedema. Participants will undergo assessments including the DASI, Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). The DASI will be administered again after a 7-day interval to evaluate test-retest reliability.
Test-retest reliability and internal consistency of the Turkish DASI will be examined. Construct validity will be evaluated by examining the relationships between DASI scores and measures of functional exercise capacity, lower extremity function, and health-related quality of life. The study aims to determine whether the Turkish version of the DASI provides a valid, reliable, and practical instrument for assessing functional capacity in women with lipedema.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women With Lipedema | – | Diagnostic Test: Duke Activity Status Index (DASI)Women diagnosed with lipedema who meet the eligibility criteria will be included in this study. Participants will undergo assessments of functional capacity, lower extremity function, and health-related quality of life using the Duke Activity Status Index (DASI), Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). The DASI will be administered again after 7 days to assess test-retest reliability. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult women diagnosed with lipedema who meet the predefined eligibility criteria. Participants will be recruited from individuals evaluated for lipedema and referred for physiotherapy assessment. Eligible participants who voluntarily agree to participate and provide informed consent will be enrolled in the study. The study population will be used to evaluate the validity and test-retest reliability of the Turkish version of the Duke Activity Status Index (DASI).
Key inclusion criteria (8 listed)
- Female sex.
- Aged 18 to <65 years.
- Diagnosis of lipedema.
- No participation in a physiotherapy program within the previous 3 months.
- No history of liposuction surgery.
Key exclusion criteria (10 listed)
- Severe visual or cognitive impairment.
- Severe cardiovascular disease.
- Musculoskeletal disorders or injuries affecting the lower extremities, including osteoarthritis, contracture, or osteoporosis, that may interfere with study assessments.
- Skin conditions that may interfere with the assessments, such as pressure ulcers.
- Uncontrolled endocrine disorders, including type 1 or type 2 diabetes mellitus or hypothyroidism.
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 |
|---|---|---|
| Duke Activity Status Index (DASI)The Duke Activity Status Index (DASI) is a 12-item self-administered questionnaire used to assess functional capacity based on activities of daily living. The total score ranges from 0 to 58.2, with higher scores indicating better functional capacity. The Turkish version of the DASI will be administered at the initial assessment and repeated after 7 days to evaluate test-retest reliability. | Diagnostic test | Women With Lipedema |
Primary outcome
Test-Retest Reliability of the Turkish Duke Activity Status Index
Time frame: Baseline and 7 days
Test-retest reliability of the Turkish version of the Duke Activity Status Index (DASI) will be evaluated by administering the questionnaire twice, with a 7-day interval. The DASI consists of 12 items assessing functional capacity during activities of daily living, with a total score ranging from 0 to 58.2; higher scores indicate better functional capacity. Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC).
Construct Validity of the Turkish Duke Activity Status Index
Time frame: Baseline-7 days
Construct validity of the Turkish DASI will be evaluated by examining the relationships between DASI scores and the Six-Minute Walk Test (6MWT), Lower Extremity Functional Scale (LEFS), and 36-Item Short Form Health Survey (SF-36). Correlation analyses will be used to determine the strength and direction of the relationships between these measures.
3 secondary outcomes
Functional Exercise Capacity - Six-Minute Walk Test
Time frame: Baseline-7 days
Lower Extremity Functional Status - LEFS
Time frame: Baseline-7 days
Health-Related Quality of Life - SF-36
Time frame: Baseline-7 days
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 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because data sharing is not included in the current study protocol or informed consent process.
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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.
1 site 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 Istanbul University - Cerrahpasa at 1 site 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 8 inclusion and 10 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Merve SEVİNC GUNDUZ, MSc (+90 5312991841, mrvsevinccc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest Reliability of the Turkish Duke Activity Status Index (time frame: Baseline and 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.