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

Not Applicable

Completed

• Conditions: Lymphedema, Breast Cancer
• Interventions: Other: Remedial exercise; Other: Compression bandage

• Registration Number: NCT05610579
• Lead Sponsor: Hacettepe University

Brief Summary

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

1. 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.

2. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Study Start: 2022-11-14
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
remedial exercises	Remedial exercise	-
remedial exercises with compression bandage	Compression bandage	-
remedial exercises with compression bandage	Remedial exercise	-

Primary Outcome Measures

Name	Time	Method
Circumference measurement	Change in symptoms related to lymphedema from baseline up to end of 24 hour	The severity of lymphedema between the two extremities will be measured by measuring the environment at 5 cm intervals.
Bioimpedance spectroscopy	Change in symptoms related to lymphedema from baseline up to end of 24 hour	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.
Ultrasonographic measurements	Change in symptoms related to lymphedema from baseline up to end of 24 hour	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.

Secondary Outcome Measures

Name	Time	Method
symptoms of lymphedema	Change in symptoms related to lymphedema from baseline up to end of 24 hour	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".

Trial Locations

Locations (1)

Gülbala Nakip; 🇹🇷 Ankara, Turkey