NCT07458932

Brief Summary

This study will be conducted with women diagnosed with lipedema who were referred to the Lymphedema Rehabilitation Unit of the Physiotherapy and Rehabilitation Department at Gazi University Faculty of Health Sciences for physiotherapy recommendations, and with healthy controls with similar characteristics. Demographic and clinical characteristics of individuals meeting the inclusion criteria and voluntarily agreeing to participate in the study will be recorded. Based on patient statements, factors limiting physical activity due to lipedema, and experiences during and after exercise will be recorded. Additionally, individuals' exercise behavior will be assessed using the Stages of Exercise Behavior Change Questionnaire, their physical activity level using the International Physical Activity Questionnaire-Short Form, and their physical activity barriers using the Self-Perceived Barriers for Physical Activity Questionnaire Data obtained from patient statements, scales, and questionnaires will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

Lipedemaexercisepainsedentary behavior

Outcome Measures

Primary Outcomes (4)

  • Physical Activity Level

    Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire is a seven-item self-report scale that assesses physical activity level over the past seven days. It includes seven questions evaluating the time individuals spend walking, moderate-intensity, vigorous activity, and sitting. A score is obtained as "MET-minutes/week" by multiplying the minutes, days, and MET value (multiples of resting oxygen consumption). The total score is calculated by summing the scores obtained from walking, moderate-intensity activity, and vigorous activity. Based on the total physical activity score, individuals' physical activity levels can be categorized as "very active, minimally active, and inactive." The Turkish version of the IPAQ-SF has been reported to be valid and reliable.

    Baseline

  • Physical Activity Barriers

    Physical activity barriers will be assessed using the Self-Perceived Barriers for Physical Activity Questionnaire. This scale is a 17-item self-report scale that evaluates perceived barriers to participation in physical activity across four subscales: Body Image and Psychosocial Anxiety (5 items); Fatigue (3 items); Obligations and Lack of Time (3 items); and Environment and Availability (4 items). Scoring is done using a Likert scale ranging from 0 to 10 (0: Less - 10: More). Each subscale score is calculated by summing the scores of each item in the subscale and dividing the total score by the number of items. Higher scores indicate higher levels of barriers.

    Baseline

  • Exercise Behavior Status

    Exercise behavior will be assessed using the Stages of Exercise Behavior Change Questionnaire. This scale consists of 5 questions. Participants will be asked to choose one of 5 situations that correspond to their current exercise level, and the change stage is determined accordingly. The individual in the precontemplation stage has never considered starting to perform exercise and does not intend to do so in the next 6 months. The individual in the contemplation stage is not actively trying to start, but only intends to start in the next 6 months. The individual in the preparation stage intends to start exercising regularly within the next 30 days. The individual in the action stage begins to change their starting behavior within a short period of time (has been exercising for less than 6 months). The individual in the maintenance stage continues to maintain the change from the action stage, has been exercising for more than 6 months, and is determined not to revert to their old habit

    baseline

  • Physical Activity and Exercise-Related Experiences and Barriers Related to Lipedema

    Women participating in the study will be asked about factors limiting physical activity related to lipedema, and their experiences during and after exercise or physical activity, and their personal statements will be recorded.

    baseline

Study Arms (2)

Lipedema Group

Women with lipedema diagnosis

Healthy control

Healthy women

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women living in Ankara, Türkiye, who have been diagnosed with lipedema

You may qualify if:

  • being between 18 and 65 years of age.

You may not qualify if:

  • having a diagnosis of cardiovascular, pulmonary, orthopedic, neurological, or cancer
  • having a body mass index \>35 kg/m2
  • having undergone surgery that limited physical activity within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LipedemaMotor ActivityPainSedentary Behavior

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 9, 2026

Study Start

December 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations