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

Lymphedema, Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610579
• Other study ID #: KA22053
• Status: Completed
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema, Breast Cancer

Intervention

Other:
• Remedial exercise
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.
• Compression bandage
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.

Locations

Country	Name	City	State
Turkey	Gülbala Nakip	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

De Vrieze T, Vos L, Gebruers N, Tjalma WAA, Thomis S, Neven P, Nevelsteen I, De Groef A, Vandermeeren L, Belgrado JP, Devoogdt N. Protocol of a randomised controlled trial regarding the effectiveness of fluoroscopy-guided manual lymph drainage for the tre — View Citation

McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD005211. doi: 10.1002/14651858.CD005211.pu — View Citation

McNeely ML, Campbell KL, Courneya KS, Mackey JR. Effect of acute exercise on upper-limb volume in breast cancer survivors: a pilot study. Physiother Can. 2009 Fall;61(4):244-51. doi: 10.3138/physio.61.4.244. Epub 2009 Nov 12. — View Citation

Ricci V, Ricci C, Gervasoni F, Andreoli A, Ozcakar L. From histo-anatomy to sonography in lymphedema: EURO-MUSCULUS/USPRM approach. Eur J Phys Rehabil Med. 2022 Feb;58(1):108-117. doi: 10.23736/S1973-9087.21.06853-2. Epub 2021 Apr 16. — View Citation

Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19. doi: 10.1002/cncr.23494. — View Citation

Svensson BJ, Dylke ES, Ward LC, Black DA, Kilbreath SL. Screening for breast cancer-related lymphoedema: self-assessment of symptoms and signs. Support Care Cancer. 2020 Jul;28(7):3073-3080. doi: 10.1007/s00520-019-05083-7. Epub 2019 Oct 22. — View Citation

Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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