Manual and Self-Lymphatic Drainage Combined With Exercise in Women With Lipedema (LipoMOVE)

September 1, 2026 updated by: Merve SEVINC GUNDUZ

Efficacy of Two Combined Interventions for Lipedema: A Randomized Comparison of Manual Lymphatic Drainage Plus Aerobic Exercise Versus Self-Lymphatic Drainage With Physical Activity Guidance

This randomized controlled study aims to compare the effects of two physiotherapy approaches in women with lipedema. Participants will be assigned to either manual lymphatic drainage combined with supervised aerobic exercise or self-lymphatic drainage combined with physical activity guidance. Both programs will be applied for six weeks. The study will investigate whether these two approaches differ in their effects on pain, lower extremity function, limb volume, mobility, quality of life, and depressive symptoms. Assessments will be performed before the intervention and at the end of the six-week program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lipedema is a chronic and progressive adipose tissue disorder that predominantly affects women and is characterized by bilateral and symmetrical disproportionate accumulation of subcutaneous adipose tissue, most commonly in the extremities. Pain, tenderness, swelling, easy bruising, and impaired mobility are common features of the condition and may negatively affect physical function and quality of life. Conservative management of lipedema aims to reduce symptoms, maintain mobility, support lymphatic drainage, and improve quality of life. Exercise, manual lymphatic drainage, self-management strategies, and physical activity are among the conservative approaches used in lipedema management.

This randomized controlled study aims to compare the effects of two combined physiotherapy approaches in women with lipedema. A total of 34 women with lipedema are planned to be included. Eligible participants will be allocated to one of two groups: manual lymphatic drainage combined with supervised aerobic exercise or self-lymphatic drainage combined with physical activity guidance.

Participants in the manual lymphatic drainage plus aerobic exercise group will receive supervised treatment twice weekly for six weeks. The aerobic exercise program will include warm-up and cool-down periods and treadmill-based aerobic exercise. Exercise intensity will be prescribed at a moderate intensity corresponding to 64-76% of maximum heart rate and will also be monitored using the Borg Rating of Perceived Exertion Scale, with a target rating of 11-13. Manual lymphatic drainage will be administered by a physiotherapist for approximately 30 minutes during each treatment session.

Participants in the self-lymphatic drainage plus physical activity group will be instructed by a physiotherapist in self-lymphatic drainage and will receive recommendations for moderate-intensity physical activity. Physical activity intensity will be guided using the Talk Test, with participants encouraged to walk at an intensity at which they can talk but not sing. Participants will be followed throughout the six-week intervention period.

Assessments will be performed at baseline and at the end of the six-week intervention. Pain intensity will be assessed using the Visual Analog Scale. Additional assessments will include health-related quality of life using the 36-Item Short Form Health Survey (SF-36), lower extremity functional status using the Lower Extremity Functional Scale, mobility using the Timed Up and Go Test, depressive symptoms using the Beck Depression Inventory, and anthropometric and limb circumference measurements. Limb circumference measurements will also be used to estimate lower extremity volume.

The study is designed to determine whether the two combined conservative physiotherapy approaches differ in their effects on pain and other clinical outcomes, including lower extremity function, mobility, limb volume, quality of life, and depressive symptoms, in women with lipedema.

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.
Interventional

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.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

Study Locations

  • Turkey (Türkiye)
    • Eyupsultan
      • Istanbul, Eyupsultan, Turkey (Türkiye)
        • Recruiting
        • Bezmialem Vakif University
        • Contact:
          • Bezmialem Vakif University Bezmialem Vakif University
          • Phone Number: +90 (212) 523 22 88
          • Email: info@bezmialem.edu.tr

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

Yes

Description

Inclusion Criteria:

Female sex. Aged 18 to 65 years. Diagnosed with lipedema. Diagnosed with Stage I, II, III, or IV lipedema. No participation in any physiotherapy program within the previous 3 months. No previous liposuction surgery. Not currently following a weight-loss diet. No change in body weight greater than 10% within the previous 6 months. Willing to participate in the study and provide informed consent.

Exclusion Criteria:

Severe visual or cognitive impairment. Severe cardiovascular disease. Musculoskeletal conditions or injuries affecting the lower extremities, including osteoarthritis, contracture, or osteoporosis, that may interfere with participation in the study.

Skin conditions that may interfere with the intervention, such as pressure ulcers.

Uncontrolled endocrine disorders, including type 1 or type 2 diabetes mellitus or hypothyroidism.

Obesity secondary to endocrine disorders or medication-induced obesity. Use of estrogen-progestin therapy within the previous 2 months. Pregnancy or a positive pregnancy test. Breastfeeding. Concurrent participation in another clinical trial.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Lymphatic Drainage + Aerobic Exercise
Participants in this arm will receive supervised manual lymphatic drainage combined with aerobic exercise twice weekly for 6 weeks. Aerobic exercise will be performed on a treadmill at moderate intensity, targeting 64-76% of maximum heart rate and a Borg Rating of Perceived Exertion of 11-13. Manual lymphatic drainage will be administered by a physiotherapist for approximately 30 minutes per session.
Other: Manual Lymphatic Drainage
Manual lymphatic drainage will be administered by a physiotherapist for approximately 30 minutes per session, twice weekly for 6 weeks. Slow, gentle, rhythmic manual techniques will be applied to facilitate lymphatic drainage.
Other: Aerobic Exercise
Participants will perform supervised moderate-intensity treadmill-based aerobic exercise twice weekly for 6 weeks. Exercise intensity will be prescribed at 64-76% of maximum heart rate and monitored using the Borg Rating of Perceived Exertion Scale, targeting a score of 11-13.
Active Comparator: Self-Lymphatic Drainage + Physical Activity Guidance
Participants assigned to this arm will receive instruction in self-lymphatic drainage and individualized physical activity guidance provided by a physiotherapist. Participants will be instructed on how to perform self-lymphatic drainage and will be encouraged to engage in moderate-intensity walking. Physical activity intensity will be guided using the Talk Test, with participants instructed to maintain an intensity at which they can talk comfortably but cannot sing. Participants will follow this program for 6 weeks and will be monitored regularly throughout the intervention period.
Other: Self-Lymphatic Drainage
Participants will be instructed by a physiotherapist on how to perform self-lymphatic drainage. They will perform the technique as part of their 6-week intervention program and will be regularly followed by the physiotherapist throughout the intervention period.
Other: Physical Activity Guidance
Participants will receive guidance from a physiotherapist to engage in moderate-intensity physical activity during the 6-week intervention period. Walking intensity will be guided using the Talk Test, with participants instructed to maintain an intensity at which they can talk but not sing. Participants will be regularly followed throughout the intervention period.

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
Pain Intensity
Time Frame: Baseline and 6 weeks
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10-cm horizontal line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst/unbearable pain." Higher scores indicate greater pain intensity.
Baseline and 6 weeks

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
Health-Related Quality of Life
Time Frame: Baseline and 6 weeks
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life.
Baseline and 6 weeks
Lower Extremity Limb Volume
Time Frame: Baseline and 6 weeks
Lower extremity circumference measurements will be obtained using a flexible, non-elastic measuring tape at standardized anatomical intervals. Limb volume will be estimated from the circumference measurements using a segmental volume calculation method. The same reference points will be used at baseline and follow-up, with lower calculated volumes indicating lower limb volume.
Baseline and 6 weeks
Lower Extremity Functional Status
Time Frame: Baseline and 6 weeks
Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS). The scale consists of 20 items assessing difficulty in performing daily activities. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 80. Higher scores indicate better lower extremity function.
Baseline and 6 weeks
Functional Mobility
Time Frame: Baseline and 6 weeks
Functional mobility will be assessed using the Timed Up and Go Test (TUG). Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the test will be recorded in seconds. A shorter completion time indicates better functional mobility.
Baseline and 6 weeks
Depressive Symptoms
Time Frame: Baseline and 6 weeks
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The questionnaire consists of 21 categories, with each item scored from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Baseline and 6 weeks

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.
Merve SEVINC GUNDUZ

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 (Actual)

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 25, 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.
January 20, 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.
January 30, 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).
September 1, 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.
September 1, 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.
September 4, 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.
September 4, 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.
September 1, 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.
September 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 2026/407 (Other Identifier: Erciyes University SBAEK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because data sharing is not included in the current study protocol or informed consent process.

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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