Validity and Reliability of the 2-Minute Step Test in Patients With Lipedema

August 4, 2026 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with lipedema

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Neuromuscular disease
  • Pregnancy
  • Advanced-stage lipo-lymphedema severely restricting ambulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test (6MWT)
Time Frame: Baseline
Functional exercise capacity assessed by the total distance walked in 6 minutes (meters). Greater walking distance indicates better functional capacity and endurance.
Baseline
Timed Up and Go Test (TUGT)
Time Frame: Baseline
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.
Baseline
Lower Extremity Functional Scale (LEFS)
Time Frame: Baseline
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.
Baseline
Visual Analog Scale (VAS)
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurdan Paker, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Istftreah15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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