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NCT Number: NCT07697482

Respiratory and Relaxation Training in Lower Extremity Lymphedema

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

Location status: Recruiting

Location contact

Deniz TUNCA, PT

CONTACT

[email protected]

+90 532 409 36 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complex Decongestive Therapy

Other

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

Other

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.

Primary outcomes

  1. Change in Muscle Oxygen Saturation

    Time frame: 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 outcomes

  1. Change in Six-Minute Walk Test Distance

    Time frame: 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.

  2. Change in Lower Extremity Limb Volume

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

İdil Esin Ünlü, Assist. Prof. Dr.

CONTACT

[email protected]

+90 506 515 66 22

Sponsors and collaborators

Lead sponsor

Toros University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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