Aerobic Exercise Effects in Lower Extremity Lymphedema

Официальное название

Effects of Aerobic Exercise on Ultrasonographic Parameters, Functional Status, Balance, and Quality of Life in Patients With Lower Extremity Lymphedema

Обзор

Lower extremity lymphedema negatively affects patients' functional status, quality of life, and activities of daily living. Complete decongestive therapy (CDT) is considered the gold-standard conservative treatment for patients with lymphedema. CDT consists of manual lymph drainage (MLD), skin care, compression bandaging, and exercise. Several studies have demonstrated the effectiveness of CDT in patients with lower extremity lymphedema. However, the results of studies investigating the effectiveness of different types of exercise are inconsistent. Moreover, most of these studies have been conducted in patients with upper extremity lymphedema, and the outcome measures have generally been limited to limb circumference measurements and quality of life assessments. To the best of our knowledge, no previous study has comprehensively evaluated the effects of aerobic exercise on both ultrasonographic parameters (quantitative data) and functional outcomes in patients with lower extremity lymphedema, as planned in the present study. Therefore, this study was designed to contribute to the existing literature by investigating these effects.

Вмешательства

• Поведенческое aerobic exercise program
  Aerobic exercise using a recumbent cycle ergometer for 20-30 minutes. The exercise intensity will be set to reach 40-60% of the maximum target heart rate reserve. The treatment program will be administered for approximately 1 hour per day, 5 days per week, for a total of 4 weeks (20 sessions).
• Другое complet decongestive therapy
  manuel lymph drainage, skin care, joint rom exercises, compression

Первичные конечные точки

• Kinesiophobia [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• musculoskeletal ultrasonography- Muscle and Subcutaneous Tissue Thickness [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• musculoskeletal ultrasonography- Subcutaneous Tissue Echogenicity [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• Balance [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• functional mobility [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• Lower limb functional status [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]

Вторичные конечные точки (3)

• fatigue [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• depression [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]
• health related quality of life [Срок оценки: baseline (before the first rehabilitation session) and immediately after completing 20 sessions of rehabilitation (4 weeks)]

Критерии участия

Критерии включения

• Diagnosis of lower extremity lymphedema (unilateral or bilateral)
• Age ≥18 years
• Absence of cognitive impairment
• Provision of written informed consent to participate in the study

Критерии исключения

• Cognitive impairment
• Presence of general contraindications to exercise (e.g., hemodynamic instability, uncontrolled hypertension, decompensated heart failure, recent myocardial infarction, or unstable angina pectoris)
• Presence of neurological diseases affecting the lower extremities that would preclude participation in the exercise program
• Presence of unhealed fractures in the lower extremities preventing exercise therapy
• Active systemic infection or local infection in the treatment area, such as cellulitis, erysipelas, or thrombophlebitis in the lower extremities
• Acute venous thromboembolic events involving the lower extremities
• Heart failure or renal failure that may cause lower extremity edema
• Presence of concomitant lipedema
• Presence of venous insufficiency
• Ongoing chemotherapy or radiotherapy (among patients with malignancy-related lymphedema)
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07726277 · 2024-TBEK-2025/12-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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