Respiratory and Relaxation Training in Lower Extremity Lymphedema

NCT07697482 | Recruiting

• 1 other identifier: 25.02.2026-1213/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Lymphedema

Keywords

Lower Extremity Lymphedema; Complex Decongestive Therapy; Respiratory Training; Relaxation Training; Muscle Oxygenation

Outcome Measures

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.

  Baseline, immediately after 15 treatment sessions, and 2-month follow-up

Secondary Outcomes (2)

• Change in Six-Minute Walk Test Distance

  Baseline, immediately after 15 treatment sessions, and 2-month follow-up

• Change in Lower Extremity Limb Volume

  Baseline, immediately after 15 treatment sessions, and 2-month follow-up

Study Arms (2)

Respiratory and relaxation

EXPERIMENTAL

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; Other: Respiratory and Relaxation Training

Complex Decongestive Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Complex Decongestive Therapy; Respiratory and relaxation

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.

Respiratory and relaxation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Respiratory Rate; Relaxation Therapy

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

İdil Esin Ünlü, Assist. Prof. Dr.

CONTACT

+90 506 515 66 22; idil.unlu@toros.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)