LipedemaNCT06811961
Effects of Exercise in Patients with Lipedema
A study testing Exercise and Physical activity in people with Lipedema, run by Ilke Keser at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic progressive disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Exercise and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2024to 5 Feb 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of Lipedema,
- Patients with Lipedema stage 1,2 and 3
Who cannot join
- Individuals with cardiopulmonary, rheumatic or neurological diagnoses that have symptoms severe enough to prevent participation in exercise,
- History of cancer, surgery or trauma that may affect the circulatory system,
- History of liposuction or orthopedic surgery within the last year,
- Individuals who cannot mobilize independently.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Health Sciences
Ankara, Emek, 06490
Ilke Keser, Prof. Dr., +90 506 4366991, ilkekeser@gazi.edu.tr
About this study
Official title: Effects of Exercise on Edema, Pain, Exercise Capacity, Lower Extremity Muscle Strength and Function in Patients with Lipedema
Lipedema is a chronic progressive disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. Healthy lifestyle approaches including exercise treatments are very important for lipedema patients in order to prevent disease progression. The aim of this study is to investigate the effects of exercise on edema, pain, exercise capacity, lower extremity muscle strength and function in lipedema patients. Sociodemographic information of the patients, body composition with Tanita InnerScan BC-601-CG device, clinical information regarding lipedema, type and stage of lipedema, inspection, palpation findings will be recorded. Local tissue water percentage will be assessed using Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device, circumference measurement using tape, pain intensity with Visual Analog Scale, pain threshold with Baseline brand digital algometer device. Muscle strength will be assessed using K-Force hand dynamometer. Functional exercise capacity will be assessed with the 6-minute walk test (6MWT), and lower extremity dysfunction with the lower extremity functional scale. After the assessments are made, the patients will be randomly divided into 2 groups. The patients in the study group will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the hip muscles and knee extensors with elastic resistance bands, which are decided according to the level of effort perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. The same assessments will be applied to the patients again at the end of the exercise program. The control group will be re-evaluated after 6 weeks with suggestions regarding lipedema and physical activity level, and the obtained data will be compared.
- Conditions
- Lipedema
- Being tested
- Exercise, Physical activity
- Keywords
- lipedema, exercise, function
- Medical subject headings
- Lipedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks.
Physical activityBehavioural
The control group will be given recommendations regarding lipedema and physical activity level.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. Receives: Behavioral: Exercise |
| Control group | Other | The control group will be given recommendations regarding lipedema and physical activity level. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tissue water percentage
Local tissue water percentage will be measured with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device. This device calculates the percentage of water under the skin by touching the reference points from the skin surface. 3 measurements will be made for each reference point and the average of these measurements will be recorded. The reference points were determined as the medial of 35 cm above the heel (calf) on both legs, the medial of 3 cm proximal to the patella (medial knee) and the lateral of 20 cm above the line drawn from 3 cm proximal to the patella to the SIAS (lateral hip).
Measured: 6 weeks
edema
For the lower extremity, the circumference will be measured at 4 cm intervals starting from the lateral malleolus to the highest point that can be reached on the inner thigh. The circumference measurement is performed while the patient is lying on his back. The results are recorded in cm and the volume calculation will be made according to the Khunke disk method.
Measured: 6 weeks
Pain severity
The leg pain due to lipedema will be recorded in cm with the Visual Analog Scale (VAS) according to the patient's statement.
Measured: 6 weeks
Pain Threshold
A Baseline brand digital algometer device will be used to assess the pain threshold. A 1 cm2 probe will be used for measurements. Before the measurement process, the midpoint of the quadriceps and tibia will be marked. The measurement will be repeated three times at 5-second intervals and the average values will be recorded in kg. The algometer will be placed at a right angle to each point, the participants will be asked to report the presence of pain by saying "yes" and the value on the device will be recorded as the pain threshold when they first feel pain at the point of touch. There will be a 5-second break between measurements.
Measured: 6 weeks
Lower extremity muscle strength
Muscle strength measurements will be made with K-Force hand dynamometer. Quadriceps Femoris and hip flexors muscle strength will be measured in sitting position and hip abductors muscle strength will be measured in side-lying position. During the measurements, patients will be asked to perform maximum isometric contraction for 5 seconds. Muscle strength measurements will be repeated 3 times on the right and left sides separately and maximum value will be recorded in kg.
Measured: 6 weeks
Lower extremity muscle endurance
Lower extremity muscle endurance measurement will be evaluated with a 30-second sit-to-stand test. The patient will be asked to stand up and sit down from a back-supported chair with their arms crossed on both shoulders for 30 seconds. Sitting down and standing less than 10 times in 30 seconds indicates a loss of lower extremity strength.
Measured: 6 weeks
functional exercise capacity
Exercise capacity will be evaluated with a 6-minute walking test. The distance covered will be recorded and interpreted as normal values. Heart rate and oxygen saturation will be measured with a portable pulse oximeter before and after the test; blood pressure will be measured with a device that automatically measures (Omron-Hem 710 Int, USA). Dyspnea and fatigue levels will be evaluated with the Modified Borg Scale (MBS) at the beginning and end of the test. The Modified Borg Scale is a scale that evaluates fatigue and shortness of breath between 0-10.
Measured: 6 weeks
lower extremity function
The lower extremity functional scale is a questionnaire consisting of 20 items developed to evaluate the lower extremity functions of patients. There are 5 options from 0 to 4 for each question (0: Extreme difficulty or inability to perform the activity, 1: Quite a bit of difficulty, 2: Moderate difficulty, 3: Some difficulty, 4: No difficulty at all). The total score varies between 0-80 and higher scores indicate better functional status.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start5 Oct 2024
- Primary completion5 Feb 2025 (estimated)
- Study completion5 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilke Keser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilke Keser, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811961
- Sponsor's protocol ID
- ElifSakizliLipedema
- Status last verified
- Oct 2024
- First submitted
- 26 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sakizli Erdal E, Ergin C, Haspolat M, Erturk B, Keser I. Effects of multimodal exercise program on edema, pain, exercise capacity, lower extremity muscle strength and function in patients with lipedema. Phlebology. 2026 Feb;41(1):47-57. doi: 10.1177/02683555251343148. Epub 2025 May 15.
PubMed 40372970
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Edema, Pain, Exercise Capacity, Lower Extremity Muscle Strength and Function in Patients with Lipedema
- ClinicalTrials.gov ID
- NCT06811961
- Acronym / sponsor ID
- ElifSakizliLipedema
- Conditions
- Lipedema
- Keywords
- lipedema, exercise, function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ilke KeserUniversity, hospital or other
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 5 Feb 2025 (estimated)
- Study completion
- 5 Feb 2025 (estimated)
- First posted
- 6 Feb 2025 (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 disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. Healthy lifestyle approaches including exercise treatments are very important for lipedema patients in order to prevent disease progression. The aim of this study is to investigate the effects of exercise on edema, pain, exercise capacity, lower extremity muscle strength and function in lipedema patients. Sociodemographic information of the patients, body composition with Tanita InnerScan BC-601-CG device, clinical information regarding lipedema, type and stage of lipedema, inspection, palpation findings will be recorded. Local tissue water percentage will be assessed using Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device, circumference measurement using tape, pain intensity with Visual Analog Scale, pain threshold with Baseline brand digital algometer device. Muscle strength will be assessed using K-Force hand dynamometer. Functional exercise capacity will be assessed with the 6-minute walk test (6MWT), and lower extremity dysfunction with the lower extremity functional scale. After the assessments are made, the patients will be randomly divided into 2 groups. The patients in the study group will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the hip muscles and knee extensors with elastic resistance bands, which are decided according to the level of effort perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. The same assessments will be applied to the patients again at the end of the exercise program. The control group will be re-evaluated after 6 weeks with suggestions regarding lipedema and physical activity level, and the obtained data will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled prospective study
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExercisePatients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. |
| Control group | Other | Behavioral: Physical activityThe control group will be given recommendations regarding lipedema and physical activity level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a diagnosis of Lipedema,
- Patients with Lipedema stage 1,2 and 3
Key exclusion criteria (4 listed)
- Individuals with cardiopulmonary, rheumatic or neurological diagnoses that have symptoms severe enough to prevent participation in exercise,
- History of cancer, surgery or trauma that may affect the circulatory system,
- History of liposuction or orthopedic surgery within the last year,
- Individuals who cannot mobilize independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatients with lipedema will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the muscles around the hips and knee extensors with elastic resistance bands, determined according to the effort level perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. | Behavioural | Exercise group |
| Physical activityThe control group will be given recommendations regarding lipedema and physical activity level. | Behavioural | Control group |
Primary outcome
Local tissue water percentage
Time frame: 6 weeks
Local tissue water percentage will be measured with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device. This device calculates the percentage of water under the skin by touching the reference points from the skin surface. 3 measurements will be made for each reference point and the average of these measurements will be recorded. The reference points were determined as the medial of 35 cm above the heel (calf) on both legs, the medial of 3 cm proximal to the patella (medial knee) and the lateral of 20 cm above the line drawn from 3 cm proximal to the patella to the SIAS (lateral hip).
edema
Time frame: 6 weeks
For the lower extremity, the circumference will be measured at 4 cm intervals starting from the lateral malleolus to the highest point that can be reached on the inner thigh. The circumference measurement is performed while the patient is lying on his back. The results are recorded in cm and the volume calculation will be made according to the Khunke disk method.
Pain severity
Time frame: 6 weeks
The leg pain due to lipedema will be recorded in cm with the Visual Analog Scale (VAS) according to the patient's statement.
Pain Threshold
Time frame: 6 weeks
A Baseline brand digital algometer device will be used to assess the pain threshold. A 1 cm2 probe will be used for measurements. Before the measurement process, the midpoint of the quadriceps and tibia will be marked. The measurement will be repeated three times at 5-second intervals and the average values will be recorded in kg. The algometer will be placed at a right angle to each point, the participants will be asked to report the presence of pain by saying "yes" and the value on the device will be recorded as the pain threshold when they first feel pain at the point of touch. There will be a 5-second break between measurements.
Lower extremity muscle strength
Time frame: 6 weeks
Muscle strength measurements will be made with K-Force hand dynamometer. Quadriceps Femoris and hip flexors muscle strength will be measured in sitting position and hip abductors muscle strength will be measured in side-lying position. During the measurements, patients will be asked to perform maximum isometric contraction for 5 seconds. Muscle strength measurements will be repeated 3 times on the right and left sides separately and maximum value will be recorded in kg.
Lower extremity muscle endurance
Time frame: 6 weeks
Lower extremity muscle endurance measurement will be evaluated with a 30-second sit-to-stand test. The patient will be asked to stand up and sit down from a back-supported chair with their arms crossed on both shoulders for 30 seconds. Sitting down and standing less than 10 times in 30 seconds indicates a loss of lower extremity strength.
functional exercise capacity
Time frame: 6 weeks
Exercise capacity will be evaluated with a 6-minute walking test. The distance covered will be recorded and interpreted as normal values. Heart rate and oxygen saturation will be measured with a portable pulse oximeter before and after the test; blood pressure will be measured with a device that automatically measures (Omron-Hem 710 Int, USA). Dyspnea and fatigue levels will be evaluated with the Modified Borg Scale (MBS) at the beginning and end of the test. The Modified Borg Scale is a scale that evaluates fatigue and shortness of breath between 0-10.
lower extremity function
Time frame: 6 weeks
The lower extremity functional scale is a questionnaire consisting of 20 items developed to evaluate the lower extremity functions of patients. There are 5 options from 0 to 4 for each question (0: Extreme difficulty or inability to perform the activity, 1: Quite a bit of difficulty, 2: Moderate difficulty, 3: Some difficulty, 4: No difficulty at all). The total score varies between 0-80 and higher scores indicate better functional status.
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 6 Feb 2025.
- Derived from this study: PubMed 40372970Sakizli Erdal E, Ergin C, Haspolat M, Erturk B, Keser I. Effects of multimodal exercise program on edema, pain, exercise capacity, lower extremity muscle strength and function in patients with lipedema. Phlebology. 2026 Feb;41(1):47-57. doi: 10.1177/02683555251343148. Epub 2025 May 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Physical activity in people with Lipedema, run by Ilke Keser 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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?
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 Elif Sakizli Erdal, Doctor of Philosophy (+ 90 506 436 6991, sakizlielif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tissue water percentage (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06811961, which also lists 1 linked publication.
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 6 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.