Respiratory and Relaxation Training in Lower Extremity Lymphedema

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Extremity Lymphedema
• Intervention / Treatment: Other: Complex Decongestive Therapy; Other: Respiratory and Relaxation Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İdil Esin Ünlü, Assist. Prof. Dr.; Phone Number: +90 506 515 66 22; Email: idil.unlu@toros.edu.tr

Study Locations

• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Adana Şehir Eğitim ve Araştırma Hastanesi
    • Contact: Deniz TUNCA, PT; Phone Number: +90 532 409 36 33; Email: denizcanoglu82@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory and relaxation; Participants in this group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with respiratory and relaxation training. Respiratory and relaxation exercises will be performed for approximately 10-20 minutes following each CDT session over 15 treatment sessions. Participants will also perform a daily home exercise program.	Other: 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.; Other: 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.
Active Comparator: Complex Decongestive Therapy; Participants in this group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises for 15 treatment sessions.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after 15 treatment sessions, and 2-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after 15 treatment sessions, and 2-month follow-up
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.	Baseline, immediately after 15 treatment sessions, and 2-month follow-up

Collaborators and Investigators

• Sponsor: Toros University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Muscle Oxygenation; Respiratory Training; Lower Extremity Lymphedema; Relaxation Training; Complex Decongestive Therapy
• Additional Relevant MeSH Terms: Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Respiration; Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Respiratory Rate; Relaxation Therapy
• Other Study ID Numbers: 25.02.2026-1213/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No