Lymphedema of LegNCT05609526
Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema
A study testing Compression Therapy, Inspiratory muscle training and Calf muscle exercise training in people with Lymphedema of Leg and Lymphedema, run by Istanbul University - Cerrahpasa.
Trial summary
Lymphedema results in the accumulation of protein-rich fluid in the subcutaneous tissue as a result of the failure of the lymphatic system, which returns water and protein in the interstitial spaces to the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Leg, Lymphedema, Exercise
- What is being tested?
- Compression Therapy, Inspiratory muscle training and Calf muscle exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having been diagnosed with lymphedema
- No visual or hearing impairment
- Being literate in Turkish
- 18- 75 years old
Who cannot join
- Acute infection
- Aardiac edema
- Peripheral arterial diseases
- Congestive advanced heart failure
- Malignant lymphedema
- Having a psychiatric disorder requiring prior vessel ablation and/or prescription medication
- Having a neurological, orthopedic or rheumatological disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Target Muscles Training in Patients With Leg Lymphedema : Inspiratory Muscles Versus Calf Muscles
Lymphedema results in the accumulation of protein-rich fluid in the subcutaneous tissue as a result of the failure of the lymphatic system, which returns water and protein in the interstitial spaces to the bloodstream. The aim of its treatment is to return this fluid accumulated in the interstitial space to the venous system. Early diagnosis and subsequent treatment of lymphedema, which is a chronic and progressive problem, is important to improve symptoms and prevent complications. Exercises recommended by specialist physiotherapists increase lymph flow and improve protein resorption. Exercises applied with compression bandages or compression garments provide significant improvement in patients with lymphedema.
The aim of this study is to provide inspiratory muscle training and leg compression therapy together with compression therapy in patients with lower extremity lymphedema.
To evaluate the effectiveness of these exercises on the patient's extremity volume and fullness, tissue water content, edema status, walking capacity, functionality and quality of life by comparing the effectiveness of muscle exercise training. In addition, researchers aim to determine the more effective exercise method for these patients.
Read the detailed description
Lymphedema is a chronic, progressive disease that occurs with the accumulation of protein-rich fluid in the interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Exercise is one of the components of Complex Relief Physiotherapy, which is used as the gold standard in the treatment of lymphedema. exercises put pressure on lymphatic vessels with rhythmic contraction and relaxation of muscle groups. Thus, smooth muscle contraction in the lymphatic vessels is triggered. The transport of lymph fluid is possible with the activation of the muscles that provide the movement of the skin. It has been shown that strengthening the calf muscle with exercise can improve the pumping function, increase the average peak torque of the muscle, decrease the severity of the disease, increase the ankle joint movement, increase the calf muscle endurance and improve the quality of life. The pump power of the inspiratory muscles is also important in the lymph circulation, as well as in the venous circulation.
This study will include 45 patients who volunteered to participate in the study, who were treated at Istanbul University- Cerrahpasa Faculty of Health Sciences and Gerontology Research and Application Center from October 2022 to October 2023. Lymphedema Quality of Life Scale for Evaluation (LYQOL) Lower Extremity Perimeter Measurement Numerical Rating Scale . 6 Minute Walk Test. Tissue Dielectric Constant (TDC) will be used.
Participants will be randomly divided into 4 groups. Only compression therapy(CT) will be given to the 1st group, inspiratory muscle training (IMT) in addition to the compression therapy to the 2nd group, and Calf muscle exercise training to the 3rd group in addition to CT.
CT will be applied to the patients in all four groups for 45-60 minutes a day, 6 days a week, for 4 weeks. Patients in the other 2 groups will participate in an exercise program for 4 weeks, 4 days a week, in addition to CT. The power analysis will be calculated based on the 5% margin of error, 95% confidence level, using the Raosoft sample size and the clinically significant minimum difference of LYMQOL, one of the primary measurement tools.
- Conditions
- Lymphedema of Leg, Lymphedema, Exercise
- Being tested
- Compression Therapy, Inspiratory muscle training, Calf muscle exercise training
- Keywords
- Diagragma, Calf Muscle
- Medical subject headings
- Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression TherapyOther
6, 8, 10 and 12 cm short tension bandages multi-layered and will be applied specifically to the extremity. Starting with the finger bandage, the pressure will be reduced as it goes distally.
Inspiratory muscle trainingOther
Maximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time per day will be 30 minutes.
Calf muscle exercise trainingOther
A strengthening treatment program will be applied to the calf muscles.dorsiflexors and plantar flexors will consist of static stretching exercise, isotonic resistance exercise with elastic resistance bands, heel and toe raising in both feet, followed by toe raising and lowering without raising the heel.
| Study group | Role | What they receive |
|---|---|---|
| 1.Group (Compression Therapy) | No intervention | The patient will be placed in the supine position. Short stretch bandages of 6, 8, 10 and 12 cm will be applied to the extremity in a multi-layered and special way. Starting with the finger bandage, the pressure will be reduced as it goes distally. The patient's gait and circulation will be checked after bandaging is finished. will be. |
| 2.Group (Inspiratory muscle training) | Experimental | Maximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time 30 minutes per day will be. On the first day, the MIP levels of the participants will be evaluated and the training workload will be determined as 30% of the MIP. For IMT, after a nose clip was inserted from the participants They will be asked to sit on the mouthpiece of the device and close their lips tightly. With the device in this position, the device for four to five breath rests after every 10 breathing cycles.
mouth, and repeat the cycle for 15 minutes. Receives: Other: Compression Therapy; Other: Inspiratory muscle training |
| 3.Group (Calf muscle exercise training) | Experimental | A strengthening treatment program will be applied to the calf muscles. CMET will consist of static stretching exercise for the dorsiflexors and plantar flexors, isotonic resistance exercise with elastic resistance bands, heel and toe lift in both feet, followed by toe raising and lowering without heel raising. An isotonic exercise (mini squat) will be performed for ankle pumping exercise and knee flexion in sitting position. Patients will begin strength training with elastic resistance bands using red bands (lowest resistance). Green and blue bands by increasing the number of sets and repetitions will start to be used (increased resistance). (31.32) Receives: Other: Compression Therapy; Other: Calf muscle exercise training |
| 4.Group (Inspiratory and calf muscle training) | Experimental | All applications made in 3 groups will be made in this group. Receives: Other: Compression Therapy; Other: Inspiratory muscle training; Other: Calf muscle exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Quality of Life Scale
Evaluates the effect of arm and leg edema on quality of life with separate questionnaires.
It consists of 4 subscales: function, appearance, symptom and mood. The score of each item ranges from 1 to 4 (1 = not at all, 2 = a little, 3 = a lot, 4 = a lot). The score of each scale is calculated by dividing the total score by the number of items and ranges from 1 to 4. It is concluded that the higher the score, the more the quality of life is affected.
Measured: 5 minute
Lower Extremity Perimeter Measurement
It will be calculated using the Frustum Formula from circumference measurements taken at 10 cm intervals from the tip of the second toe to the thigh. Patients' affected and unaffected lower extremities will be measured with standard fiberglass. Measurements will be made by the same physiotherapist before and after the 4-week intervention.
Measured: 5 minute
Secondary outcomes (3)
Numerical Rating Scale
Subjective feedback of patients regarding leg fullness associated with lymphedema will be recorded by the scoring method of the affected lower extremity. This scoring will be between 0 and 10.
Measured: 5 minute
6-Minute Walk Test
It is used to determine walking capacity by measuring the maximum distance an individual can walk in six minutes.
Measured: 10minute
Tissue Dielectric Constant (TDC)
The tissue dielectric constant (TDC) technique gives information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start14 Nov 2022 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion12 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of LegStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Mazı, Istanbul University - Cerrahpasa
- Investigators
- Ahmet Akgül, Study director, dean at university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609526
- Sponsor's protocol ID
- IstanbulUC-AKGUL-001
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sander AP, Hajer NM, Hemenway K, Miller AC. Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. Phys Ther. 2002 Dec;82(12):1201-12.
PubMed 12444879Kocak Z, Overgaard J. Risk factors of arm lymphedema in breast cancer patients. Acta Oncol. 2000;39(3):389-92. doi: 10.1080/028418600750013168.
PubMed 10987236Gashev AA. Physiologic aspects of lymphatic contractile function: current perspectives. Ann N Y Acad Sci. 2002 Dec;979:178-87; discussion 188-96. doi: 10.1111/j.1749-6632.2002.tb04878.x.
PubMed 12543727Olszewski WL. Contractility patterns of human leg lymphatics in various stages of obstructive lymphedema. Ann N Y Acad Sci. 2008;1131:110-8. doi: 10.1196/annals.1413.010.
PubMed 18519964Browse NL. The pathogenesis of venous ulceration: a hypothesis. J Vasc Surg. 1988 Mar;7(3):468-72. doi: 10.1067/mva.1988.avs0070468. No abstract available.
PubMed 3346962Szuba A, Rockson SG. Lymphedema: anatomy, physiology and pathogenesis. Vasc Med. 1997 Nov;2(4):321-6. doi: 10.1177/1358863X9700200408.
PubMed 9575606Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
PubMed 35710091Do JH, Kim W, Cho YK, Lee J, Song EJ, Chun YM, Jeon JY. EFFECTS OF RESISTANCE EXERCISES AND COMPLEX DECONGESTIVE THERAPY ON ARM FUNCTION AND MUSCULAR STRENGTH IN BREAST CANCER RELATED LYMPHEDEMA. Lymphology. 2015 Dec;48(4):184-96.
PubMed 27164764Keeley V. Quality of life assessment tools in chronic oedema. Br J Community Nurs. 2008 Oct;13(10):S22-7. doi: 10.12968/bjcn.2008.13.Sup5.31193.
PubMed 19057479Solari E, Marcozzi C, Negrini D, Moriondo A. Lymphatic Vessels and Their Surroundings: How Local Physical Factors Affect Lymph Flow. Biology (Basel). 2020 Dec 11;9(12):463. doi: 10.3390/biology9120463.
PubMed 33322476Akgul A, Mazi I, Aydin G, Yavuz M, Yeldan I. The effect of muscles in the treatment of lower limb lymphedema: respiratory muscles or leg muscles? Support Care Cancer. 2025 Apr 11;33(5):375. doi: 10.1007/s00520-025-09436-3.
PubMed 40214771
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Muscles Training in Patients With Leg Lymphedema : Inspiratory Muscles Versus Calf Muscles
- ClinicalTrials.gov ID
- NCT05609526
- Acronym / sponsor ID
- IstanbulUC-AKGUL-001
- Conditions
- Lymphedema of Leg, Lymphedema, Exercise
- Keywords
- Diagragma, Calf Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 14 Nov 2022 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 12 Sep 2023 (estimated)
- First posted
- 8 Nov 2022 (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.
Lymphedema results in the accumulation of protein-rich fluid in the subcutaneous tissue as a result of the failure of the lymphatic system, which returns water and protein in the interstitial spaces to the bloodstream. The aim of its treatment is to return this fluid accumulated in the interstitial space to the venous system. Early diagnosis and subsequent treatment of lymphedema, which is a chronic and progressive problem, is important to improve symptoms and prevent complications. Exercises recommended by specialist physiotherapists increase lymph flow and improve protein resorption. Exercises applied with compression bandages or compression garments provide significant improvement in patients with lymphedema.
The aim of this study is to provide inspiratory muscle training and leg compression therapy together with compression therapy in patients with lower extremity lymphedema.
To evaluate the effectiveness of these exercises on the patient's extremity volume and fullness, tissue water content, edema status, walking capacity, functionality and quality of life by comparing the effectiveness of muscle exercise training. In addition, researchers aim to determine the more effective exercise method for these patients.
Detailed description
Lymphedema is a chronic, progressive disease that occurs with the accumulation of protein-rich fluid in the interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Exercise is one of the components of Complex Relief Physiotherapy, which is used as the gold standard in the treatment of lymphedema. exercises put pressure on lymphatic vessels with rhythmic contraction and relaxation of muscle groups. Thus, smooth muscle contraction in the lymphatic vessels is triggered. The transport of lymph fluid is possible with the activation of the muscles that provide the movement of the skin. It has been shown that strengthening the calf muscle with exercise can improve the pumping function, increase the average peak torque of the muscle, decrease the severity of the disease, increase the ankle joint movement, increase the calf muscle endurance and improve the quality of life. The pump power of the inspiratory muscles is also important in the lymph circulation, as well as in the venous circulation.
This study will include 45 patients who volunteered to participate in the study, who were treated at Istanbul University- Cerrahpasa Faculty of Health Sciences and Gerontology Research and Application Center from October 2022 to October 2023. Lymphedema Quality of Life Scale for Evaluation (LYQOL) Lower Extremity Perimeter Measurement Numerical Rating Scale . 6 Minute Walk Test. Tissue Dielectric Constant (TDC) will be used.
Participants will be randomly divided into 4 groups. Only compression therapy(CT) will be given to the 1st group, inspiratory muscle training (IMT) in addition to the compression therapy to the 2nd group, and Calf muscle exercise training to the 3rd group in addition to CT.
CT will be applied to the patients in all four groups for 45-60 minutes a day, 6 days a week, for 4 weeks. Patients in the other 2 groups will participate in an exercise program for 4 weeks, 4 days a week, in addition to CT. The power analysis will be calculated based on the 5% margin of error, 95% confidence level, using the Raosoft sample size and the clinically significant minimum difference of LYMQOL, one of the primary measurement tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.Group (Compression Therapy) | No intervention | –The patient will be placed in the supine position. Short stretch bandages of 6, 8, 10 and 12 cm will be applied to the extremity in a multi-layered and special way. Starting with the finger bandage, the pressure will be reduced as it goes distally. The patient's gait and circulation will be checked after bandaging is finished. will be. |
| 2.Group (Inspiratory muscle training) | Experimental | Other: Compression Therapy, Other: Inspiratory muscle trainingMaximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time 30 minutes per day will be. On the first day, the MIP levels of the participants will be evaluated and the training workload will be determined as 30% of the MIP. For IMT, after a nose clip was inserted from the participants They will be asked to sit on the mouthpiece of the device and close their lips tightly. With the device in this position, the device for four to five breath rests after every 10 breathing cycles. mouth, and repeat the cycle for 15 minutes. |
| 3.Group (Calf muscle exercise training) | Experimental | Other: Compression Therapy, Other: Calf muscle exercise trainingA strengthening treatment program will be applied to the calf muscles. CMET will consist of static stretching exercise for the dorsiflexors and plantar flexors, isotonic resistance exercise with elastic resistance bands, heel and toe lift in both feet, followed by toe raising and lowering without heel raising. An isotonic exercise (mini squat) will be performed for ankle pumping exercise and knee flexion in sitting position. Patients will begin strength training with elastic resistance bands using red bands (lowest resistance). Green and blue bands by increasing the number of sets and repetitions will start to be used (increased resistance). (31.32) |
| 4.Group (Inspiratory and calf muscle training) | Experimental | Other: Compression Therapy, Other: Inspiratory muscle training, Other: Calf muscle exercise trainingAll applications made in 3 groups will be made in this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with lymphedema
- No visual or hearing impairment
- Being literate in Turkish
- 18- 75 years old
Key exclusion criteria (7 listed)
- Acute infection
- Aardiac edema
- Peripheral arterial diseases
- Congestive advanced heart failure
- Malignant lymphedema
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 |
|---|---|---|
| Compression Therapy6, 8, 10 and 12 cm short tension bandages multi-layered and will be applied specifically to the extremity. Starting with the finger bandage, the pressure will be reduced as it goes distally. | Other | 2.Group (Inspiratory muscle training), 3.Group (Calf muscle exercise training), 4.Group (Inspiratory and calf muscle training) |
| Inspiratory muscle trainingMaximum inspiratory intraoral pressure (MIP) and expiratory intraoral pressure (MEP) will be measured before patients begin IMT. Total training time per day will be 30 minutes. | Other | 2.Group (Inspiratory muscle training), 4.Group (Inspiratory and calf muscle training) |
| Calf muscle exercise trainingA strengthening treatment program will be applied to the calf muscles.dorsiflexors and plantar flexors will consist of static stretching exercise, isotonic resistance exercise with elastic resistance bands, heel and toe raising in both feet, followed by toe raising and lowering without raising the heel. | Other | 3.Group (Calf muscle exercise training), 4.Group (Inspiratory and calf muscle training) |
Primary outcome
Lymphedema Quality of Life Scale
Time frame: 5 minute
Evaluates the effect of arm and leg edema on quality of life with separate questionnaires. It consists of 4 subscales: function, appearance, symptom and mood. The score of each item ranges from 1 to 4 (1 = not at all, 2 = a little, 3 = a lot, 4 = a lot). The score of each scale is calculated by dividing the total score by the number of items and ranges from 1 to 4. It is concluded that the higher the score, the more the quality of life is affected.
Lower Extremity Perimeter Measurement
Time frame: 5 minute
It will be calculated using the Frustum Formula from circumference measurements taken at 10 cm intervals from the tip of the second toe to the thigh. Patients' affected and unaffected lower extremities will be measured with standard fiberglass. Measurements will be made by the same physiotherapist before and after the 4-week intervention.
3 secondary outcomes
Numerical Rating Scale
Time frame: 5 minute
6-Minute Walk Test
Time frame: 10minute
Tissue Dielectric Constant (TDC)
Time frame: 5 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Background: PubMed 12444879Sander AP, Hajer NM, Hemenway K, Miller AC. Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. Phys Ther. 2002 Dec;82(12):1201-12.
- Background: PubMed 10987236Kocak Z, Overgaard J. Risk factors of arm lymphedema in breast cancer patients. Acta Oncol. 2000;39(3):389-92. doi: 10.1080/028418600750013168.
- Background: PubMed 12543727Gashev AA. Physiologic aspects of lymphatic contractile function: current perspectives. Ann N Y Acad Sci. 2002 Dec;979:178-87; discussion 188-96. doi: 10.1111/j.1749-6632.2002.tb04878.x.
- Background: PubMed 18519964Olszewski WL. Contractility patterns of human leg lymphatics in various stages of obstructive lymphedema. Ann N Y Acad Sci. 2008;1131:110-8. doi: 10.1196/annals.1413.010.
- Background: PubMed 3346962Browse NL. The pathogenesis of venous ulceration: a hypothesis. J Vasc Surg. 1988 Mar;7(3):468-72. doi: 10.1067/mva.1988.avs0070468. No abstract available.
- Background: PubMed 9575606Szuba A, Rockson SG. Lymphedema: anatomy, physiology and pathogenesis. Vasc Med. 1997 Nov;2(4):321-6. doi: 10.1177/1358863X9700200408.
- Background: PubMed 35710091Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
- Background: PubMed 27164764Do JH, Kim W, Cho YK, Lee J, Song EJ, Chun YM, Jeon JY. EFFECTS OF RESISTANCE EXERCISES AND COMPLEX DECONGESTIVE THERAPY ON ARM FUNCTION AND MUSCULAR STRENGTH IN BREAST CANCER RELATED LYMPHEDEMA. Lymphology. 2015 Dec;48(4):184-96.
- Background: PubMed 19057479Keeley V. Quality of life assessment tools in chronic oedema. Br J Community Nurs. 2008 Oct;13(10):S22-7. doi: 10.12968/bjcn.2008.13.Sup5.31193.
- Background: PubMed 33322476Solari E, Marcozzi C, Negrini D, Moriondo A. Lymphatic Vessels and Their Surroundings: How Local Physical Factors Affect Lymph Flow. Biology (Basel). 2020 Dec 11;9(12):463. doi: 10.3390/biology9120463.
- Derived from this study: PubMed 40214771Akgul A, Mazi I, Aydin G, Yavuz M, Yeldan I. The effect of muscles in the treatment of lower limb lymphedema: respiratory muscles or leg muscles? Support Care Cancer. 2025 Apr 11;33(5):375. doi: 10.1007/s00520-025-09436-3.
- 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. This study is not recruiting at the moment.
Ahmet Akgül study director
dean at university
Questions about this trial
What is this clinical trial studying?
A study testing Compression Therapy, Inspiratory muscle training and Calf muscle exercise training in people with Lymphedema of Leg and Lymphedema, run by Istanbul University - Cerrahpasa.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İLKNUR MAZI (+90 541 731 92 32, mazilknur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphedema Quality of Life Scale (time frame: 5 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609526, which also lists 11 linked publications.
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 18 Nov 2022.