Respiratory and Relaxation Training in Lower Extremity Lymphedema

Официальное название

Effect of Respiratory and Relaxation Training Added to Complex Decongestive Therapy on Functional Capacity and Muscle Oxygenation in Patients With Lower Extremity Lymphedema: A Single-Center Randomized Controlled Trial

Обзор

This randomized controlled trial aims to investigate the effectiveness of respiratory and relaxation training added to standard complex decongestive therapy (CDT) on muscle oxygenation, functional capacity, and limb volume in patients with lower extremity lymphedema. Participants will be randomly assigned to receive either standard CDT alone or CDT combined with respiratory and relaxation exercises. Outcomes will be assessed before treatment, immediately after treatment, and two months after completion.

Подробное описание

Lower extremity lymphedema is a chronic condition characterized by impaired lymphatic drainage, limb swelling, pain, reduced physical function, and decreased quality of life. Complex decongestive therapy (CDT) is considered the gold standard treatment; however, additional interventions that may improve physiological and functional outcomes remain under investigation.

Respiratory exercises may facilitate lymphatic return through changes in intrathoracic pressure, whereas relaxation training may reduce sympathetic activation and improve exercise tolerance. Despite these theoretical benefits, there is limited evidence regarding their combined effect on muscle oxygenation in patients with lower extremity lymphedema.

Therefore, this randomized controlled study will evaluate whether adding respiratory and relaxation training to CDT improves muscle oxygenation measured by wearable near-infrared spectroscopy (MOXY), functional capacity assessed with the Six-Minute Walk Test, and limb volume compared with CDT alone.

Вмешательства

• Другое Complex Decongestive Therapy
  Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy (bandaging and/or compression garments), skin care education, and therapeutic exercises. Treatment will be provided in 15 sessions according to the standard clinical protocol.
• Другое Respiratory and Relaxation Training
  A structured respiratory and relaxation program performed after each Complex Decongestive Therapy session. The intervention includes diaphragmatic breathing, thoracic expansion exercises, prolonged expiration breathing, and progressive muscle relaxation or breathing awareness exercises for approximately 10-20 minutes per session. Participants will also be instructed to perform the exercises at home once or twice daily.

Первичные конечные точки

• Change in Muscle Oxygen Saturation [Срок оценки: Baseline, immediately after 15 treatment sessions, and 2-month follow-up]

Вторичные конечные точки (2)

• Change in Six-Minute Walk Test Distance [Срок оценки: Baseline, immediately after 15 treatment sessions, and 2-month follow-up]
• Change in Lower Extremity Limb Volume [Срок оценки: Baseline, immediately after 15 treatment sessions, and 2-month follow-up]

Критерии участия

Критерии включения

• Female patients aged 18 years or older.
• Clinically diagnosed with secondary lower extremity lymphedema.
• Presence of lower extremity lymphedema for at least 3 months.
• Able to stand and walk independently to complete the Six-Minute Walk Test.
• Willing and able to provide written informed consent.

Критерии исключения

• Acute cellulitis or other active infection within the previous 2-4 weeks.
• Current or recent deep vein thrombosis (DVT) or uncontrolled peripheral vascular disease.
• Severe cardiovascular, pulmonary, orthopedic, or neurological conditions that could interfere with participation or outcome assessments.
• Pregnancy.
• Skin lesions or irritation preventing placement of the near-infrared spectroscopy (MOXY) sensor.
• Inability to comply with the study protocol or follow-up assessments.

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

Простое слепое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Adana Şehir Eğitim ve Araştırma Hastanesi — Adana

Идентификаторы

NCT: NCT07697482 · 25.02.2026-1213/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗