- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07803913
Validity and Reliability of the Turkish Duke Activity Status Index in Women With Lipedema (DASI-LIP)
Validity and Reliability Study of the Turkish Version of the Duke Activity Status Index in Patients With Lipedema
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Merve SEVİNC GUNDUZ, MSc
- Phone Number: +90 5312991841
- Email: mrvsevinccc@gmail.com
Study Locations
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Eyupsultan
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Istanbul, Eyupsultan, Turkey (Türkiye), 34250
- Recruiting
- Bezmialem Vakif University
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Contact:
- Merve SEVİNC GUNDUZ, MSc
- Phone Number: 05312991841
- Email: mrvsevinccc@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Test-Retest Reliability of the Turkish Duke Activity Status Index
Time Frame: Baseline and 7 days
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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).
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Baseline and 7 days
|
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Construct Validity of the Turkish Duke Activity Status Index
Time Frame: Baseline-7 days
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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.
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Baseline-7 days
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Secondary Outcome Measures
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.
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Baseline-7 days
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Lower Extremity Functional Status - LEFS
Time Frame: Baseline-7 days
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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.
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Baseline-7 days
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Health-Related Quality of Life - SF-36
Time Frame: Baseline-7 days
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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.
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Baseline-7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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