The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema

Study Overview
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Brief Summary
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The aim of this study to investigate 24 hours of effects of remedial exercises with and without compression therapy on severity of lymphedema and symptoms of the lymphedema The present study is designed as a non-drug clinical trial. The patients will complete two remedial exercise sessions, one without and one with compression in a randomized order separated by a 3-day wash-out period.The main questions it aims to answer are The 24 hour effects of remedial exercises with and without compression therapy on the severity of lymphedema are different in individuals with lymphedema associated with breast cancer surgery. The 24 hour effects of remedial exercises with and without compression therapy on the symptoms of lymphedema are different in individuals with lymphedema associated with breast cancer surgery.

Official Title
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The 24 Hour Effects of Remedial Exercises With and Without Compression Therapy on Breast Cancer-related Lymphedema

Conditions
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Lymphedema, Breast Cancer

Intervention / Treatment
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* Other: Remedial exercise
* Other: Compression bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- Age between 18 and 75 years 2 cm or greater difference between the affected and unaffected arms in women with breast cancer related lymphedema At least 12 months after breast cancer surgery end Exclusion Criteria: current recurrence of breast cancer bilateral involvement active infection presence of metastases diabetes mellitus hypertension pre-existing neuromusculoskeletal and neurological conditions edema due to other reasons (e.g., primary lymphedema, lung and heart diseases)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: remedial exercises with compression bandage<br> | Other: Remedial exercise<br>* Remedial exercise program will be taught by qualified physiotherapist. Patients will be practiced to the exercise 3 sets of 15 repetitions without compression. Patients will be monitored telephonically in the washout period for remain the routine activities.<br>Other: Compression bandage<br>* Multi-layered short stretch bandaging will be applied for 23 hour. Patients will be practiced to the exercise 3 sets of 15 repetitions with compression bandage. The bandage will be removed at the same time the next day. Patients will be monitored telephonically in the washout period for remain the routine activities.<br>|
| Active Comparator: remedial exercises<br> | Other: Remedial exercise<br>* Remedial exercise program will be taught by qualified physiotherapist. Patients will be practiced to the exercise 3 sets of 15 repetitions without compression. Patients will be monitored telephonically in the washout period for remain the routine activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic measurements | Ultrasound imaging was performed using a 5-13-Megahertz linear probe. During the procedure, the participants will be seated with their forearms supinated and extended on a pillow. Measurements will be made bilaterally from 10 cm distal and proximal to the elbow bend, from the midpoint of the medial and lateral epicondyles, along the line parallel to the arm axis. | Change in symptoms related to lymphedema from baseline up to end of 24 hour | 
| Circumference measurement | The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals. | Change in symptoms related to lymphedema from baseline up to end of 24 hour | 
| Bioimpedance spectroscopy | The patient is in the supine position with his arms and legs not touching each other. This measurement will be made using the Impedimed L-Dex U 400 device. The reference point is the top of both hands and the dorsum of the foot. This measurement is made using superficial electrodes and there is no risk. The percentage of fluid will be calculated by making a measurement for both arms. | Change in symptoms related to lymphedema from baseline up to end of 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms of lymphedema | Four participant-reported lymphedema symptoms were assessed: swelling, heaviness, tightness commonly associated with BCRL. Using a 100 mm visual analogue scale (VAS), participants marked on it the extent to which they perceived their arm to be swollen, heavy or tight and pain during the past month, with 0 being not at all and 10 being extremely. | Change in symptoms related to lymphedema from baseline up to end of 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression therapy, lymphedema, exercise