Ireland
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Recruiting Not applicable

Respiratory and Relaxation Training in Lower Extremity Lymphedema

NCT07697482 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-03-01
Last updated
2026-07-13

Condition(s) studied

Lower Extremity Lymphedema

Investigational drug(s) / intervention(s)

Complex Decongestive TherapyRespiratory and Relaxation Training

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.

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.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in Muscle Oxygen Saturation — Baseline, immediately after 15 treatment sessions, and 2-month follow-up
    Muscle oxygen saturation will be assessed using a wearable near-infrared spectroscopy device placed over the vastus lateralis muscle. SmO₂ values will be recorded before, during, and after the Six-Minute Walk Test.

Trial sites (1)

FacilityCityRegionStatus
Adana Şehir Eğitim ve Araştırma Hastanesi Adana Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07697482 on ClinicalTrials.gov ↗ ← All trials in Turkey