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NCT Number: NCT07803913

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Eyupsultan, 34250, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merve SEVİNC GUNDUZ, MSc

CONTACT

[email protected]

05312991841

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve SEVİNC GUNDUZ, MSc

CONTACT

[email protected]

+90 5312991841

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Validity and Reliability Study of the Turkish Version of the Duke Activity Status Index in Patients With Lipedema

Acronym: DASI-LIP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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