Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema

Efficacy of Complex Decongestive Therapy, Exercise, and Nutritional Interventions in Women Diagnosed With Lipedema: A Prospective, Single-Blind, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lipedema
• Intervention / Treatment: Other: Anti-inflammatory Diet and Physical Therapy; Other: Standard Diet and Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nilay Sahin, Prof. Dr.; Phone Number: +90 555 233 2535; Email: dincernilay@yahoo.com
• Study Contact Backup: Name: Ender Salbas, Assist. Prof. Dr.; Phone Number: +90 555 669 8639; Email: endersalbas@balikesir.edu.tr

Study Locations

• Turkey (Türkiye)
  • Balıkesir, Turkey (Türkiye), 10145
    • Balikesir University Faculty of Medicine Hospital
    • Contact: Nilay Sahin, Prof. Dr.; Phone Number: +90 555 233 2535; Email: dincernilay@yahoo.com
    • Contact: Ender Salbas, Assist. Prof. Dr.; Phone Number: +90 555 669 8639; Email: endersalbas@balikesir.edu.tr
    • Principal Investigator: Nilay Sahin, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-inflammatory Diet + Physical Therapy; 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).	Other: Anti-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.
Active Comparator: Standard Diet + Physical Therapy; 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).	Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Balikesir University
• Investigators: Principal Investigator: Nilay Sahin, Prof. Dr., Balikesir University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: exercise; Physical Therapy; diet; Lipedema; Complex Decongestive Therapy
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Behavior; Skin and Connective Tissue Diseases; Lipedema; Motor Activity; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: Lipedema_75T253G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No