Validity and Reliability of the Turkish Duke Activity Status Index in Women With Lipedema (DASI-LIP)

September 1, 2026 updated by: Merve SEVINC GUNDUZ, Istanbul University - Cerrahpasa

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Eyupsultan
      • Istanbul, Eyupsultan, Turkey (Türkiye), 34250
        • Recruiting
        • Bezmialem Vakif University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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. Use of estrogen-progestin therapy within the previous 2 months. Pregnancy or a positive pregnancy test. Breastfeeding. Concurrent participation in another clinical trial.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 7 days
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.
Baseline-7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Exercise Capacity - Six-Minute Walk Test
Time Frame: Baseline-7 days
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.
Baseline-7 days
Lower Extremity Functional Status - LEFS
Time Frame: Baseline-7 days
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.
Baseline-7 days
Health-Related Quality of Life - SF-36
Time Frame: Baseline-7 days
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.
Baseline-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/406 (Other Identifier: Bezmialem Vakif University Scientific Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because data sharing is not included in the current study protocol or informed consent process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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