LipedemaNCT07458932
Evaluation of Physical Activity in Women With Lipedema
An observational study of Lipedema, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women living in Ankara, Türkiye, who have been diagnosed with lipedema
Who may be able to join
- being between 18 and 65 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences
Ankara, 06490
About this study
Official title: Exercise Behavior, Physical Activity, and Perceived Barriers in Women With Lipedema: A Case-Control Study
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.
- Conditions
- Lipedema
- Keywords
- Lipedema, exercise, pain, sedentary behavior
- Medical subject headings
- Lipedema, Motor Activity, Pain, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lipedema Group | Women with lipedema diagnosis | |
| Healthy control | Healthy women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start15 Dec 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458932
- Sponsor's protocol ID
- 2025-2081
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 23 Apr 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Behavior, Physical Activity, and Perceived Barriers in Women With Lipedema: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07458932
- Acronym / sponsor ID
- 2025-2081
- Conditions
- Lipedema
- Keywords
- Lipedema, exercise, pain, sedentary behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 9 Mar 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipedema Group | – | –Women with lipedema diagnosis |
| Healthy control | – | –Healthy women |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women living in Ankara, Türkiye, who have been diagnosed with lipedema
Key inclusion criteria (1 listed)
- being between 18 and 65 years of age.
Key exclusion criteria (3 listed)
- 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.
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
Physical Activity Level
Time frame: Baseline
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.
Physical Activity Barriers
Time frame: Baseline
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.
Exercise Behavior Status
Time frame: baseline
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
Physical Activity and Exercise-Related Experiences and Barriers Related to Lipedema
Time frame: baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: Baseline). The study lists 4 primary outcomes in all. 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 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.