Respiratory and Relaxation Training in Lower Extremity Lymphedema
ConditionLower Extremity Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorToros University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Complex Decongestive Therapy
Other interventionStandard 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
Other interventionA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Respiratory and relaxationExperimental treatment 2 interventions
Group B: Complex Decongestive TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Muscle Oxygen Saturation
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.
Time frame
Baseline, immediately after 15 treatment sessions, and 2-month follow-upSecondary outcomes
1
Change in Six-Minute Walk Test Distance
Functional capacity will be assessed using the Six-Minute Walk Test. The total walking distance covered in six minutes will be recorded in meters.
Time frame
Baseline, immediately after 15 treatment sessions, and 2-month follow-up2
Change in Lower Extremity Limb Volume
Limb volume will be calculated from serial circumference measurements taken at 4-cm intervals from the lateral malleolus using the truncated cone formula.
Time frame
Baseline, immediately after 15 treatment sessions, and 2-month follow-upSponsors and contacts
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Source ClinicalTrials.gov