LipedemaNCT07752017
Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Trial summary
Lipedema is a chronic, progressive adipose tissue disorder that predominantly affects women and is characterized by symmetric, disproportionate subcutaneous fat accumulation in the lower extremities, pain, tenderness, and easy bruising. It is associated with reduced mobility and impaired functional capacity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 10 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: Patients with lipedema
Who may be able to join
- Clinically diagnosed with lipedema according to the Wold and Halk-Damstra criteria, stage 2 and above
- Aged 18-65 years, female
- No walking-limiting pathology
- Willing to participate
Who cannot join
- Uncontrolled hypertension
- Decompensated cardiac failure
- Systemic, degenerative, neurological, rheumatological, or orthopedic disease affecting lower-extremity function
- Lower-extremity surgery within the past 6 months
- Peripheral artery disease causing vascular claudication
- Severe psychiatric disorder (active psychosis, severe major depression) or cognitive impairment preventing compliance with test instructions
Show all 9Show fewer
- Neuromuscular disease
- Pregnancy
- Advanced-stage lipo-lymphedema severely restricting ambulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Construct Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema: A Cross-Sectional Study
Lipedema is a chronic, progressive adipose tissue disorder that predominantly affects women and is characterized by symmetric, disproportionate subcutaneous fat accumulation in the lower extremities, pain, tenderness, and easy bruising. It is associated with reduced mobility and impaired functional capacity. Although the 2-Minute Step Test (2MST) is a practical, low-cost measure of functional capacity that requires no equipment or large space, its validity and reliability have not been investigated in patients with lipedema. The aim of this study is to evaluate the construct validity and test-retest reliability of the 2MST in women with lipedema.
Read the detailed description
This prospective, cross-sectional study will enroll 55 women diagnosed with lipedema (stage 2 and above) according to the Wold and Halk-Damstra criteria. Participants will undergo the 2-Minute Step Test (2MST), the 6-Minute Walk Test (6MWT), the Timed Up and Go Test (TUGT), the Visual Analog Scale (VAS) for pain, and the Lower Extremity Functional Scale (LEFS). Vital signs (blood pressure, oxygen saturation, heart rate) will be checked before testing. Tests will be administered in a fixed order (2MST, then 6MWT, then TUGT) with at least 30 minutes of rest between them, by the same examiner, at similar times of day. To assess test-retest reliability, the 2MST will be repeated after a 7-day interval by the same examiner. Reliability will be evaluated using the intraclass correlation coefficient (ICC) with 95% confidence intervals, standard error of measurement (SEM), and minimum detectable change (MDC95). Construct validity will be evaluated using Spearman correlation coefficients between the 2MST and the 6MWT, TUGT, LEFS, and VAS.
- Conditions
- Lipedema
- Medical subject headings
- Lipedema
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Minute Step Test (2MST)
Functional exercise capacity assessed by the number of times the participant raises the knee to the required height during 2 minutes. Higher scores indicate better functional exercise capacity.
Measured: Baseline
Secondary outcomes (4)
6-Minute Walk Test (6MWT)
Functional exercise capacity assessed by the total distance walked in 6 minutes (meters). Greater walking distance indicates better functional capacity and endurance.
Measured: Baseline
Timed Up and Go Test (TUGT)
Functional mobility assessed by the time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down (seconds). Longer completion times indicate poorer functional mobility and balance.
Measured: Baseline
Lower Extremity Functional Scale (LEFS)
Self-reported lower extremity function assessed using a 20-item questionnaire with a total score ranging from 0 to 80. Higher scores indicate better lower extremity function and less disability.
Measured: Baseline
Visual Analog Scale (VAS)
Pain intensity assessed using a 100-mm visual analog scale ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nurdan Paker, Prof, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752017
- Sponsor's protocol ID
- Istftreah15
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07752017
- Acronym / sponsor ID
- Istftreah15
- Conditions
- Lipedema
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipedema is a chronic, progressive adipose tissue disorder that predominantly affects women and is characterized by symmetric, disproportionate subcutaneous fat accumulation in the lower extremities, pain, tenderness, and easy bruising. It is associated with reduced mobility and impaired functional capacity. Although the 2-Minute Step Test (2MST) is a practical, low-cost measure of functional capacity that requires no equipment or large space, its validity and reliability have not been investigated in patients with lipedema. The aim of this study is to evaluate the construct validity and test-retest reliability of the 2MST in women with lipedema.
Detailed description
This prospective, cross-sectional study will enroll 55 women diagnosed with lipedema (stage 2 and above) according to the Wold and Halk-Damstra criteria. Participants will undergo the 2-Minute Step Test (2MST), the 6-Minute Walk Test (6MWT), the Timed Up and Go Test (TUGT), the Visual Analog Scale (VAS) for pain, and the Lower Extremity Functional Scale (LEFS). Vital signs (blood pressure, oxygen saturation, heart rate) will be checked before testing. Tests will be administered in a fixed order (2MST, then 6MWT, then TUGT) with at least 30 minutes of rest between them, by the same examiner, at similar times of day. To assess test-retest reliability, the 2MST will be repeated after a 7-day interval by the same examiner. Reliability will be evaluated using the intraclass correlation coefficient (ICC) with 95% confidence intervals, standard error of measurement (SEM), and minimum detectable change (MDC95). Construct validity will be evaluated using Spearman correlation coefficients between the 2MST and the 6MWT, TUGT, LEFS, and VAS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with lipedema
Key inclusion criteria (4 listed)
- Clinically diagnosed with lipedema according to the Wold and Halk-Damstra criteria, stage 2 and above
- Aged 18-65 years, female
- No walking-limiting pathology
- Willing to participate
Key exclusion criteria (9 listed)
- Uncontrolled hypertension
- Decompensated cardiac failure
- Systemic, degenerative, neurological, rheumatological, or orthopedic disease affecting lower-extremity function
- Lower-extremity surgery within the past 6 months
- Peripheral artery disease causing vascular claudication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-Minute Step Test (2MST)
Time frame: Baseline
Functional exercise capacity assessed by the number of times the participant raises the knee to the required height during 2 minutes. Higher scores indicate better functional exercise capacity.
4 secondary outcomes
6-Minute Walk Test (6MWT)
Time frame: Baseline
Timed Up and Go Test (TUGT)
Time frame: Baseline
Lower Extremity Functional Scale (LEFS)
Time frame: Baseline
Visual Analog Scale (VAS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nurdan Paker, Prof principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Aydın, MD (2124445434, merveay9702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Minute Step Test (2MST) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.