Clinical trial NCT05609526: Inspiratory and Calf Muscles Training in Patients With Leg Lymphedema
Official title: Target Muscles Training in Patients With Leg Lymphedema : Inspiratory Muscles Versus Calf Muscles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema of Leg
Lymphedema
Exercise
Keywords: Diagragma
Calf Muscle
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with lymphedema
* No visual or hearing impairment
* Being literate in Turkish
* 18- 75 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lymphedema Quality of Life Scale
timeFrame: 5 minute
measure: Lower Extremity Perimeter Measurement
timeFrame: 5 minute
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: 5 minute
measure: 6-Minute Walk Test
timeFrame: 10minute
measure: Tissue Dielectric Constant (TDC)
timeFrame: 5 minute
Other outcomes:
Locations:
Study officials:
affiliation: dean at university
name: Ahmet Akgül
role: STUDY_DIRECTOR
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