Lower Extremity LymphedemaNCT07697482
Respiratory and Relaxation Training in Lower Extremity Lymphedema
A study testing Complex Decongestive Therapy and Respiratory and Relaxation Training in people with Lower Extremity Lymphedema, run by Toros University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- Complex Decongestive Therapy and Respiratory and Relaxation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana
Deniz TUNCA, PT, +90 532 409 36 33, denizcanoglu82@gmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Lower Extremity Lymphedema
- Being tested
- Complex Decongestive Therapy, Respiratory and Relaxation Training
- Keywords
- Lower Extremity Lymphedema, Complex Decongestive Therapy, Respiratory Training, Relaxation Training, Muscle Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive TherapyOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Complex Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after 15 treatment sessions, and 2-month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, immediately after 15 treatment sessions, and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idil Esin Unlu, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697482
- Sponsor's protocol ID
- 25.02.2026-1213/23
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07697482
- Acronym / sponsor ID
- 25.02.2026-1213/23
- Conditions
- Lower Extremity Lymphedema
- Keywords
- Lower Extremity Lymphedema, Complex Decongestive Therapy, Respiratory Training, Relaxation Training, Muscle Oxygenation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Respiratory and relaxation | Experimental | Other: Complex Decongestive Therapy, Other: Respiratory and Relaxation TrainingParticipants 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. |
| Complex Decongestive Therapy | Active comparator | Other: Complex Decongestive TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Decongestive TherapyStandard 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 | Complex Decongestive Therapy, Respiratory and relaxation |
| Respiratory and Relaxation TrainingA 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. | Other | Respiratory and relaxation |
Primary outcome
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.
2 secondary outcomes
Change in Six-Minute Walk Test Distance
Time frame: Baseline, immediately after 15 treatment sessions, and 2-month follow-up
Change in Lower Extremity Limb Volume
Time frame: Baseline, immediately after 15 treatment sessions, and 2-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy and Respiratory and Relaxation Training in people with Lower Extremity Lymphedema, run by Toros University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İdil Esin Ünlü, Assist. Prof. Dr. (+90 506 515 66 22, idil.unlu@toros.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Oxygen Saturation (time frame: Baseline, immediately after 15 treatment sessions, and 2-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.