Validity and Reliability of the Turkish Duke Activity Status Index in Women With Lipedema

NCT07803913 | Recruiting

• 1 other identifier: 2026/406
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lipedema

Keywords

Duke Activity Status Index; DASI; Functional Capacity; Validity; Reliability; Test-Retest Reliability; Lower Extremity Function; Exercise Capacity; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline-7 days

Secondary Outcomes (3)

• Functional Exercise Capacity - Six-Minute Walk Test

  Baseline-7 days

• Lower Extremity Functional Status - LEFS

  Baseline-7 days

• Health-Related Quality of Life - SF-36

  Baseline-7 days

Study Arms (1)

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)

Interventions

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.

Women With Lipedema

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyupsultan, 34250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Merve SEVİNC GUNDUZ, MSc

CONTACT

+90 5312991841; mrvsevinccc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)