LipedemaNCT07885241
Telerehabilitation-Supported Exercise in Women With Lipedema
A study testing Telerehabilitation-Supported Exercise and Home Exercise Program in people with Lipedema, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-blind, randomized controlled trial aims to evaluate the effectiveness of a telerehabilitation-supported exercise program in women with lipedema. A total of 66 women aged 18 to 65 years with stage I-III lipedema will be included and randomly assigned to either the telerehabilitation group or… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Telerehabilitation-Supported Exercise and Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2026to Jul 2027
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants with a clinical diagnosis of lipedema confirmed according to the revised Wold criteria
- Stage I-III lipedema
- Age between 18 and 65 years
- Body mass index ≤40 kg/m²
- No cardiac, pulmonary, or orthopedic medical contraindication to exercise
- Ability to use a smartphone, tablet, or computer and access to an active internet connection
Show all 9Show fewer
- Ability and motivation to participate regularly in telerehabilitation sessions
- Willingness to participate voluntarily and provide written informed consent
- Ability to ambulate independently on level surfaces without an assistive device or assistance from another person
Who cannot join
- Presence of systemic disease that may prevent safe participation in exercise, including uncontrolled cardiovascular, metabolic, or pulmonary disease; neurological, hematological, or rheumatological disease; or malignancy
- Musculoskeletal pathology that may limit exercise performance, including advanced knee or hip osteoarthritis, severe deformity, or acute muscle or joint injury
- Pregnancy or breastfeeding
- Acute infection, open skin lesion, skin ulcer, or advanced lipodermatosclerosis
- Liposuction or major surgery within the previous three months
- Participation in physical therapy or a regular exercise program within the previous three months
- Severe psychiatric or cognitive disorder that may interfere with treatment adherence
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
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, 34080
About this study
Official title: The Effect of a Telerehabilitation-Supported Exercise Program on Pain, Functional Status, and Quality of Life in Women With Lipedema: A Single-Blind Prospective Randomized Controlled Trial
This prospective, single-blind, randomized controlled trial aims to evaluate the effectiveness of a telerehabilitation-supported exercise program in women with lipedema. A total of 66 women aged 18 to 65 years with stage I-III lipedema will be included and randomly assigned to either the telerehabilitation group or the home exercise group.
Participants in the telerehabilitation group will perform a supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. Participants in the control group will perform a similar home-based exercise program independently three times per week for 12 weeks. Both groups will receive education about lipedema and instructions regarding the exercise program.
The primary outcome is pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include pressure pain threshold, lipedema-related symptoms, lower-extremity volume, subcutaneous tissue thickness, body composition, functional capacity, mobility, quality of life, and exercise adherence.
- Conditions
- Lipedema
- Being tested
- Telerehabilitation-Supported Exercise, Home Exercise Program
- Keywords
- telerehabilitation, exercise, pain, functional status, quality of life, lipoedema, physical rehabilitation
- Medical subject headings
- Lipedema, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation-Supported ExerciseOther
A supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program consists of warm-up, strengthening, and cool-down exercises. Strengthening exercises are performed at approximately 50-60% of one-repetition maximum with progression during the intervention period. Participants also receive education about lipedema and written exercise materials
Home Exercise ProgramOther
A home-based exercise program performed independently three times per week for 12 weeks. The exercise content is similar to the telerehabilitation group and participants receive education about lipedema, written exercise materials, and an exercise monitoring form
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation-Supported Exercise Group | Experimental | Participants in this group will receive a telerehabilitation-supported exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program includes warm-up, strengthening, and cool-down exercises. Participants will also receive education about lipedema and written exercise materials Receives: Other: Telerehabilitation-Supported Exercise |
| Home Exercise Group | Active comparator | Participants in this group will perform a similar home-based exercise program independently three times per week for 12 weeks. They will receive education about lipedema, written exercise materials, and an exercise monitoring form Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by Visual Analog Scale (VAS)
Pain severity in the affected extremities will be assessed using a 10-cm Visual Analog Scale. The scale ranges from "no pain" to "the most severe pain imaginable." Participants will be asked to mark the point on the line that best represents the severity of their pain. The distance from the beginning of the scale to the marked point will be measured and recorded as the pain score. Higher scores indicate greater pain severity.
Measured: Baseline, week 12, week 24
Secondary outcomes (9)
Six-Minute Walk Test
Walking capacity and exercise tolerance will be assessed using the 6-Minute Walk Test in a 30-meter corridor. Participants will be instructed to walk as many laps as possible during 6 minutes. At the beginning of each minute, the assessor will remind the participant of the remaining time and provide standardized verbal encouragement. The total distance walked at the end of 6 minutes will be recorded in meters. A greater walking distance indicates better functional exercise capacity.
Measured: Baseline and Week 12, week 24
Lower Extremity Function Assessed by Lower Extremity Functional Scale (LEFS)
Functional capacity during activities of daily living will be assessed using the 20-item Lower Extremity Functional Scale. Each item is scored from 0 to 4: 0 indicates inability to perform the activity or extreme difficulty, 1 indicates quite a bit of difficulty, 2 indicates moderate difficulty, 3 indicates a little difficulty, and 4 indicates no difficulty. The total score ranges from 0 to 80, with higher scores indicating better lower extremity functional capacity.
Measured: Baseline and Week 12, week 24
Lipedema-Related Symptoms
The severity of 12 lipedema-related symptoms will be assessed using 10-cm Visual Analog Scales. The evaluated symptoms include pain, tenderness to touch and pressure, swelling, fullness or tightness, heaviness, excessive sensations of heat or cold, easy bruising, fatigue, difficulty walking, reduced quality of life, and dissatisfaction with leg appearance. Each scale ranges from "no symptom" to "the most severe symptom." Higher scores indicate greater symptom severity.
Measured: Baseline and Week 12, week 24
Pressure Pain Threshold Assessed by Algometry
Pressure pain threshold will be assessed using a digital algometer. Before measurement, the anterior thigh, pretibial region, lateral aspect of the leg, and medial supramalleolar region of both lower extremities will be marked. The algometer will be applied perpendicular to each measurement point. Participants will indicate when pressure is first perceived as painful, and the value displayed on the device will be recorded as the pressure pain threshold. Measurements will be repeated three times at each point at 5-second intervals, and the mean value will be calculated.
Measured: Baseline and Week 12, week 24
Lower Extremity Volume Assessed by Circumference Measurements
Bilateral leg circumference measurements will be obtained while participants are in the supine position. Measurements will begin at the level of the lateral malleolus and continue proximally at 4-cm intervals up to 56 cm. All measurements will be recorded in centimeters. The obtained circumference measurements will be used to calculate total lower extremity and thigh volume according to the principles of the Kuhnke disc method. Percentage changes in volume will be calculated at follow-up assessments.
Measured: Baseline and Week 12, week 24
Quality of Life Assessed by Short Form-36 (SF-36)
Quality of life will be assessed using the Short Form-36 Health Survey. The scale consists of eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Physical and mental health component scores will also be evaluated.
Measured: Baseline and Week 12, week 24
Subcutaneous Tissue Thickness Assessed by Ultrasonography
Subcutaneous tissue thickness will be measured using a MYLAB Esaote 60 ultrasound device with a 7-13 MHz linear transducer while participants are in the supine position. Measurements will be obtained bilaterally from predefined reference areas at the anterior thigh, pretibial region, lateral aspect of the leg, and medial supramalleolar region. The transducer will be positioned perpendicular to the dermal-subcutaneous junction. Three measurements will be obtained from each region, and the mean value will be recorded.
Measured: Baseline and Week 12, week 24
30-Second Sit-to-Stand Test
Lower extremity muscle strength and functional endurance will be assessed using the 30-Second Chair Stand Test. Participants will be instructed to repeatedly stand up from and sit down on a chair with back support while keeping their arms crossed over their chest. The number of correctly completed repetitions within 30 seconds will be recorded. A higher number of repetitions indicates better lower extremity strength and functional endurance.
Measured: Baseline and Week 12, week 24
Timed Up and Go Test
Mobility and balance will be assessed using the Timed Up and Go Test. 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 task will be measured and recorded in seconds. A shorter completion time indicates better functional mobility and balance.
Measured: Baseline, Week 12. week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
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 Istanbul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized controlled trial comparing telerehabilitation-supported exercise with a home exercise program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehri Güner, Istanbul University
- Investigators
- Ekin Ilke SEN, MD, Principal investigator, Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885241
- Sponsor's protocol ID
- E-29624016-050.99-3909371
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Telerehabilitation-Supported Exercise Program on Pain, Functional Status, and Quality of Life in Women With Lipedema: A Single-Blind Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07885241
- Acronym / sponsor ID
- E-29624016-050.99-3909371
- Conditions
- Lipedema
- Keywords
- telerehabilitation, exercise, pain, functional status, quality of life, lipoedema, physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Oct 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 prospective, single-blind, randomized controlled trial aims to evaluate the effectiveness of a telerehabilitation-supported exercise program in women with lipedema. A total of 66 women aged 18 to 65 years with stage I-III lipedema will be included and randomly assigned to either the telerehabilitation group or the home exercise group.
Participants in the telerehabilitation group will perform a supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. Participants in the control group will perform a similar home-based exercise program independently three times per week for 12 weeks. Both groups will receive education about lipedema and instructions regarding the exercise program.
The primary outcome is pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include pressure pain threshold, lipedema-related symptoms, lower-extremity volume, subcutaneous tissue thickness, body composition, functional capacity, mobility, quality of life, and exercise adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial comparing telerehabilitation-supported exercise with a home exercise program.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation-Supported Exercise Group | Experimental | Other: Telerehabilitation-Supported ExerciseParticipants in this group will receive a telerehabilitation-supported exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program includes warm-up, strengthening, and cool-down exercises. Participants will also receive education about lipedema and written exercise materials |
| Home Exercise Group | Active comparator | Other: Home Exercise ProgramParticipants in this group will perform a similar home-based exercise program independently three times per week for 12 weeks. They will receive education about lipedema, written exercise materials, and an exercise monitoring form |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female participants with a clinical diagnosis of lipedema confirmed according to the revised Wold criteria
- Stage I-III lipedema
- Age between 18 and 65 years
- Body mass index ≤40 kg/m²
- No cardiac, pulmonary, or orthopedic medical contraindication to exercise
Key exclusion criteria (7 listed)
- Presence of systemic disease that may prevent safe participation in exercise, including uncontrolled cardiovascular, metabolic, or pulmonary disease; neurological, hematological, or rheumatological disease; or malignancy
- Musculoskeletal pathology that may limit exercise performance, including advanced knee or hip osteoarthritis, severe deformity, or acute muscle or joint injury
- Pregnancy or breastfeeding
- Acute infection, open skin lesion, skin ulcer, or advanced lipodermatosclerosis
- Liposuction or major surgery within the previous three months
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 |
|---|---|---|
| Telerehabilitation-Supported ExerciseA supervised exercise program delivered synchronously via Zoom three times per week for 12 weeks. The program consists of warm-up, strengthening, and cool-down exercises. Strengthening exercises are performed at approximately 50-60% of one-repetition maximum with progression during the intervention period. Participants also receive education about lipedema and written exercise materials | Other | Telerehabilitation-Supported Exercise Group |
| Home Exercise ProgramA home-based exercise program performed independently three times per week for 12 weeks. The exercise content is similar to the telerehabilitation group and participants receive education about lipedema, written exercise materials, and an exercise monitoring form | Other | Home Exercise Group |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline, week 12, week 24
Pain severity in the affected extremities will be assessed using a 10-cm Visual Analog Scale. The scale ranges from "no pain" to "the most severe pain imaginable." Participants will be asked to mark the point on the line that best represents the severity of their pain. The distance from the beginning of the scale to the marked point will be measured and recorded as the pain score. Higher scores indicate greater pain severity.
9 secondary outcomes
Six-Minute Walk Test
Time frame: Baseline and Week 12, week 24
Lower Extremity Function Assessed by Lower Extremity Functional Scale (LEFS)
Time frame: Baseline and Week 12, week 24
Lipedema-Related Symptoms
Time frame: Baseline and Week 12, week 24
Pressure Pain Threshold Assessed by Algometry
Time frame: Baseline and Week 12, week 24
Lower Extremity Volume Assessed by Circumference Measurements
Time frame: Baseline and Week 12, week 24
Quality of Life Assessed by Short Form-36 (SF-36)
Time frame: Baseline and Week 12, week 24
Subcutaneous Tissue Thickness Assessed by Ultrasonography
Time frame: Baseline and Week 12, week 24
30-Second Sit-to-Stand Test
Time frame: Baseline and Week 12, week 24
Timed Up and Go Test
Time frame: Baseline, Week 12. week 24
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and data protection considerations.
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Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Lipedema
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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.
Ekin Ilke SEN, MD principal investigator
Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation-Supported Exercise and Home Exercise Program in people with Lipedema, run by Istanbul 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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Oct 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?
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 Mehri Guner, MD (+905428125439, mehriguner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Baseline, week 12, week 24). 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 27 Oct 2026.