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

2026年7月28日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

75

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • トルコ（Türkiye）
      • Balıkesir、トルコ（Türkiye）、10145
        • Balikesir University Faculty of Medicine Hospital
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Nilay Sahin, Prof. Dr.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
他の：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.
アクティブコンパレータ：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).
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Lower Extremity Circumference
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Body Weight
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Balikesir University

捜査官

  • 主任研究者：Nilay Sahin, Prof. Dr.、Balikesir University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年12月15日

研究の完了 (推定)

2027年12月15日

試験登録日

最初に提出

2026年4月11日

QC基準を満たした最初の提出物

2026年6月21日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月29日

QC基準を満たした最後の更新が送信されました

2026年7月28日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Lipedema_75T253G

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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