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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-inflammatory Diet + Physical Therapy | Experimental | Participants in this arm will receive a personalized anti-inflammatory diet plan formulated by the Physical Medicine and Rehabilitation clinic, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise). |
|
| Standard Diet + Physical Therapy | Active Comparator | Participants in this arm will receive standard healthy nutrition education, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-inflammatory Diet and Physical Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Circumference | 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. | Baseline, Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight (kg) measured at each assessment visit using standardized equipment. Change from baseline will be evaluated. | Baseline, Week 6, and Week 12 |
| Change in Subcutaneous tissue thickness (mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nilay Sahin, Prof. Dr. | Contact | +90 555 233 2535 | dincernilay@yahoo.com | |
| Ender Salbas, Assist. Prof. Dr. | Contact | +90 555 669 8639 | endersalbas@balikesir.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Nilay Sahin, Prof. Dr. | Balikesir University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balikesir University Faculty of Medicine Hospital | Balıkesir | 10145 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.
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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.
|
| Standard Diet and Physical Therapy | Other | 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. |
|
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.
| Baseline, Week 6, and Week 12 |
| Change in Dermis thickness (mm) | 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. | Baseline, Week 6, and Week 12 |
| Change in Fibrous Septa Prominence | 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. | Baseline, Week 6, and Week 12 |
| Change in Subcutaneous Fat Tissue Echogenicity | 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. | Baseline, Week 6, and Week 12 |
| Change in Rectus Femoris Muscle Thickness | Rectus femoris muscle thickness will be measured by ultrasound in millimeters (mm) at a standardized anatomical site. Change from baseline will be evaluated. | Baseline, Week 6, and Week 12 |
| Change in Rectus Femoris Muscle Echogenicity | 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. | Baseline, Week 6, and Week 12 |
| Change in Abdominal Subcutaneous Adipose Tissue Thickness | 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. | Baseline, Week 6, and Week 12 |
| Change in Functional Capacity | 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. | Baseline, Week 6, and Week 12 |
| Change in Pain Severity | 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. | Baseline, Week 6, and Week 12 |
| Change in Patient Benefit Index-Lymphedema (PBI-L) Score | 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. | Baseline, Week 6, and Week 12 |
| Change in LYMQOL-Leg Score | 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. | Baseline, Week 6, and Week 12 |
| Change in SF-12 Physical Component Summary Score | 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. | Baseline, Week 6, and Week 12 |
| Change in SF-12 Mental Component Summary Score | 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. | Baseline, Week 6, and Week 12 |
| Change in Beck Depression Inventory Score | 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. | Baseline, Week 6, and Week 12 |