Bezmialem Vakif University
Istanbul, Eyupsultan, 34250, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07803913
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.
Interested in participating?
Request Info18 year–65 year
Female
Observational
Istanbul, Eyupsultan, 34250, Turkey (Türkiye)
Location status: Recruiting
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.
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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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.
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).
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Istanbul University - Cerrahpasa
Other
Validity and Reliability Study of the Turkish Version of the Duke Activity Status Index in Patients With Lipedema
Acronym: DASI-LIP
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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