Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema
NCT ID: NCT05609526
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
45 participants
INTERVENTIONAL
2022-11-14
2023-09-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Inspiratory Muscle Training on Lymphedema
NCT06521268
High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema
NCT05650372
The Effect of Inspiratory Exercises on Diaphragm and Intercostal Muscle Thickness in Stroke Patients
NCT07206641
Evaluation of Respiratory Parameters in Patients With Upper Limb Lymphedema
NCT06568978
Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit
NCT06609564
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1.Group (Compression Therapy)
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.
No interventions assigned to this group
2.Group (Inspiratory muscle training)
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.
Compression Therapy
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 training
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.
3.Group (Calf muscle exercise training)
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)
Compression Therapy
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.
Calf muscle exercise training
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.
4.Group (Inspiratory and calf muscle training)
All applications made in 3 groups will be made in this group.
Compression Therapy
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 training
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 training
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Compression Therapy
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 training
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 training
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No visual or hearing impairment
* Being literate in Turkish
* 18- 75 years old
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ilknur Mazı
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmet Akgül
Role: STUDY_DIRECTOR
dean at university
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kocak Z, Overgaard J. Risk factors of arm lymphedema in breast cancer patients. Acta Oncol. 2000;39(3):389-92. doi: 10.1080/028418600750013168.
Gashev 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.
Olszewski 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.
Browse 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.
Szuba A, Rockson SG. Lymphedema: anatomy, physiology and pathogenesis. Vasc Med. 1997 Nov;2(4):321-6. doi: 10.1177/1358863X9700200408.
Aydin 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.
Do 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.
Keeley 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.
Solari 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.
Akgul 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IstanbulUC-AKGUL-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.