Respiratory and Relaxation Training added to standard complex decongestive therapy for lower leg lymphedema
Official title: 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
Run by Toros University · NCT07697482 · Data updated 2026-11-12
This trial tests whether adding breathing and relaxation practices to standard care helps people with secondary lower-extremity lymphedema feel and function better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Toros University Academic / other |
| Locations | 1 site (Adana) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07697482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (18+) with secondary lower-extremity lymphedema of at least 3 months who can stand and walk independently.
✕Probably not a fit
Individuals with active infection, severe comorbidities, pregnancy, or skin issues preventing MOXY sensor placement may not benefit or participate safely.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized study, participants with secondary lower-extremity lymphedema receive either standard complex decongestive therapy (CDT) alone or CDT plus respiratory and relaxation training. Outcomes include muscle oxygenation measured with MOXY, functional capacity via the Six-Minute Walk Test, and limb volume, assessed at baseline, after treatment, and two months later. The trial aims to determine if the combined approach improves physiological and functional endpoints beyond CDT alone. Eligible participants are adult women with long-standing lower-extremity lymphedema who can walk independently. The study is conducted at Adana Şehir Eğitim ve Araştırma Hastanesi with Toros University as the lead sponsor.
Why it matters
Potential benefit: If successful, patients may experience better muscle oxygenation, increased walking capacity, and reduced limb volume when respiratory and relaxation training is added to CDT.
How similar studies have gone: Previous work suggests potential physiological benefits of adjunct breathing and relaxation strategies, but evidence for this specific combination in lower-extremity lymphedema is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: İdil Esin Ünlü, Assist. Prof. Dr.
- Email: idil.unlu@toros.edu.tr
- Phone: +90 506 515 66 22
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.