Lipedema
Conditions
Keywords
Lipedema, diet, exercise, Complex Decongestive Therapy, Physical Therapy
Brief summary
The purpose of this study is to compare the effectiveness of standard physical therapy methods (Complex Decongestive Therapy, Pneumatic Compression, and Exercise) combined with two different nutritional approaches (personalized anti-inflammatory diet vs. standard healthy nutrition education) in women diagnosed with lower extremity lipedema.
Detailed description
This single-center, prospective, single-blind, randomized controlled trial will include 75 female participants aged 18-65 with Stage I, II, or III lipedema. Participants will receive either a personalized anti-inflammatory diet or standard nutrition education, alongside a standard 12-week physical therapy protocol. Evaluations will be conducted at baseline, 4th, 8th, and 12th weeks to measure changes in lower extremity circumference/volume, body composition, ultrasonographic tissue characteristics, functional capacity (6MWT), pain severity (VAS), and quality of life.
Interventions
OTHERAnti-inflammatory Diet and Physical Therapy
A personalized anti-inflammatory diet plan formulated by the clinic, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
OTHERStandard Diet and Physical Therapy
Standard healthy nutrition education, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
Sponsors
Balikesir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor, who will perform the clinical measurements, ultrasound evaluations, and questionnaires at baseline and all follow-up time points, will be blinded to the group allocation of the participants.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: an experimental group receiving a personalized anti-inflammatory diet and a control group receiving standard nutrition education. Both groups will simultaneously receive a standard physical therapy protocol.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female, aged 18 to 65 years. * Clinical and physical examination confirming Stage I, II, or III lipedema. * Body Mass Index (BMI) \< 45 kg/m\^2. * Ability to walk without restriction.
Exclusion criteria
* Presence of active malignancy. * Decompensated heart failure. * Significant lower extremity peripheral artery disease. * Acute deep vein thrombosis or active thromboembolism. * Pregnancy. * Significant sensory loss or severe neuropathy in the lower extremities. * History of lower extremity liposuction within the last 12 months. * Active severe infection (e.g., cellulitis). * Other severe systemic diseases deemed unsafe for the study by researchers. * Severe non-compliance with the study protocol (e.g., missing \>30% of planned sessions) or participant requesting withdrawal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Circumference | Baseline, Week 6, and Week 12 | Lower extremity circumferences will be measured in centimeters (cm) using a standardized tape measure at predefined anatomical landmarks, including the foot dorsum, ankle, and at 10-cm intervals proximally below the knee, as well as at the thigh. Change in lower extremity circumference from baseline will be evaluated within and between study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, Week 6, and Week 12 | Body weight (kg) measured at each assessment visit using standardized equipment. Change from baseline will be evaluated. |
| Change in Subcutaneous tissue thickness (mm) | Baseline, Week 6, and Week 12 | Subcutaneous tissue thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated. |
| Change in Dermis thickness (mm) | Baseline, Week 6, and Week 12 | Dermis thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated. |
| Change in Fibrous Septa Prominence | Baseline, Week 6, and Week 12 | The prominence of fibrous septa within the subcutaneous tissue will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater fibrotic septal prominence. Change from baseline will be evaluated. |
| Change in Subcutaneous Fat Tissue Echogenicity | Baseline, Week 6, and Week 12 | Subcutaneous fat tissue echogenicity will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater echogenicity. Change from baseline will be evaluated. |
| Change in Rectus Femoris Muscle Thickness | Baseline, Week 6, and Week 12 | Rectus femoris muscle thickness will be measured by ultrasound in millimeters (mm) at a standardized anatomical site. Change from baseline will be evaluated. |
| Change in Rectus Femoris Muscle Echogenicity | Baseline, Week 6, and Week 12 | Rectus femoris muscle echogenicity will be assessed by ultrasound at a standardized anatomical site using a visual grading scale from Grade 1 to Grade 3. Higher grades indicate greater muscle echogenicity. Change from baseline will be evaluated. |
| Change in Abdominal Subcutaneous Adipose Tissue Thickness | Baseline, Week 6, and Week 12 | Abdominal subcutaneous adipose tissue thickness will be measured by ultrasound in millimeters (mm) at locations 5 cm above and 5 cm below the umbilicus. The mean of these two measurements will be used for analysis. Change from baseline will be evaluated. |
| Change in Functional Capacity | Baseline, Week 6, and Week 12 | Assessment of submaximal exercise capacity using the 6-Minute Walk Test (6MWT). The total distance walked in 6 minutes will be recorded in meters (m). A higher score indicates better functional capacity. |
| Change in Pain Severity | Baseline, Week 6, and Week 12 | Evaluation of leg pain intensity using the Visual Analog Scale (VAS). Scale range: 0 (no pain) to 10 (unbearable pain); lower scores indicate better outcome. Change from baseline will be evaluated. |
| Change in Patient Benefit Index-Lymphedema (PBI-L) Score | Baseline, Week 6, and Week 12 | The Patient Benefit Index-Lymphedema (PBI-L) is a patient-reported outcome measure used to assess the perceived benefit of treatment in individuals with lymphedema. It includes 23 items addressing treatment goals and the extent to which these goals have been achieved. Scores range from 0 to 4, with higher scores indicating greater patient-perceived treatment benefit. Change from baseline to the specified follow-up time point will be evaluated. |
| Change in LYMQOL-Leg Score | Baseline, Week 6, and Week 12 | The LYMQOL-Leg is an 18-item, lymphedema-specific quality-of-life questionnaire for patients with lower-limb lymphedema. It assesses the impact of lymphedema across relevant quality-of-life domains. Domain scores range from 1 to 4, with lower scores indicating a better outcome and less lymphedema-related impairment. Change from baseline to the specified follow-up time point will be assessed. |
| Change in SF-12 Physical Component Summary Score | Baseline, Week 6, and Week 12 | The 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) score assesses physical health status, including physical functioning, role limitations due to physical health, bodily pain, and general health perceptions. Scores range from 0 to 100, with higher scores indicating better physical health status. Change from baseline to the specified follow-up time point will be analyzed. |
| Change in SF-12 Mental Component Summary Score | Baseline, Week 6, and Week 12 | The SF-12 Mental Component Summary (MCS) score assesses mental health status, including psychological well-being, emotional role functioning, social functioning, and vitality. Scores range from 0 to 100, with higher scores indicating better mental health status. Change from baseline to the specified follow-up time point will be evaluated. |
| Change in Beck Depression Inventory Score | Baseline, Week 6, and Week 12 | The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with lower scores indicating fewer depressive symptoms. Change from baseline to the specified follow-up time point will be assessed, with a decrease in score indicating improvement. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNilay Sahin, Prof. Dr.
CONTACTEnder Salbas, Assist. Prof. Dr.
PRINCIPAL_INVESTIGATORNilay Sahin, Prof. Dr.
Balikesir University
Outcome results
None listed