Lower Extremity Lymphedema
Conditions
Keywords
Lower Extremity Lymphedema, Complex Decongestive Therapy, Respiratory Training, Relaxation Training, Muscle Oxygenation
Brief 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.
Detailed description
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.
Interventions
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.
OTHERRespiratory 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.
Sponsors
Toros University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating physiotherapists cannot be blinded because of the nature of the intervention. However, the outcome assessor responsible for collecting all outcome measures, including muscle oxygenation, functional capacity, and limb volume, will be blinded to group allocation. Participants will be instructed not to disclose their treatment assignment to the assessor. Data analysis will be performed using coded group assignments.
Intervention model description
Participants will be randomly allocated to either standard Complex Decongestive Therapy or Complex Decongestive Therapy combined with respiratory and relaxation training. Both groups will be followed in parallel throughout the study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Six-Minute Walk Test Distance | Baseline, immediately after 15 treatment sessions, and 2-month follow-up | Functional capacity will be assessed using the Six-Minute Walk Test. The total walking distance covered in six minutes will be recorded in meters. |
| Change in Lower Extremity Limb Volume | Baseline, immediately after 15 treatment sessions, and 2-month follow-up | Limb volume will be calculated from serial circumference measurements taken at 4-cm intervals from the lateral malleolus using the truncated cone formula. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİdil Esin Ünlü, Assist. Prof. Dr.
Outcome results
None listed