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

28. července 2026 aktualizováno: Nilay Sahin, Balikesir University

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

75

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Turecko (Türkiye)
      • Balıkesir, Turecko (Türkiye), 10145
        • Balikesir University Faculty of Medicine Hospital
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Nilay Sahin, Prof. Dr.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Jiný: 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.
Aktivní komparátor: 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).
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Lower Extremity Circumference
Časové okno: 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.
Baseline, Week 6, and Week 12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Body Weight
Časové okno: Baseline, Week 6, and Week 12
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)
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Dermis thickness (mm)
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Fibrous Septa Prominence
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Subcutaneous Fat Tissue Echogenicity
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Thickness
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Echogenicity
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Abdominal Subcutaneous Adipose Tissue Thickness
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Functional Capacity
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Pain Severity
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Patient Benefit Index-Lymphedema (PBI-L) Score
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in LYMQOL-Leg Score
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in SF-12 Physical Component Summary Score
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in SF-12 Mental Component Summary Score
Časové okno: 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.
Baseline, Week 6, and Week 12
Change in Beck Depression Inventory Score
Časové okno: 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.
Baseline, Week 6, and Week 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Balikesir University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Nilay Sahin, Prof. Dr., Balikesir University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

15. prosince 2027

Dokončení studie (Odhadovaný)

15. prosince 2027

Termíny zápisu do studia

První předloženo

11. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

21. června 2026

První zveřejněno (Aktuální)

25. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Lipedema_75T253G

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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