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

NCT05610579 | Completed

• 1 other identifier: KA22053
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Lymphedema, Breast Cancer

Keywords

compression therapy; lymphedema; exercise

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• symptoms of lymphedema

  Change in symptoms related to lymphedema from baseline up to end of 24 hour

Study Arms (2)

remedial exercises with compression bandage

EXPERIMENTAL

Other: Remedial exercise; Other: Compression bandage

remedial exercises

ACTIVE COMPARATOR

Other: Remedial exercise

Interventions

Remedial exercise OTHER

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.

remedial exercises; remedial exercises with compression bandage

Compression bandage OTHER

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.

remedial exercises with compression bandage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of unilateral arm lymphedema related to breast cancer disease- Age between 18 and 75 years
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Gülbala Nakip

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (7)

• 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.pub2.

  PMID: 20556760 RESULT

• 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.

  PMID: 20808486 RESULT

• 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.

  PMID: 18428212 RESULT

• 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 treatment of breast cancer-related lymphoedema (EFforT-BCRL trial). Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:177-188. doi: 10.1016/j.ejogrb.2017.12.023. Epub 2017 Dec 16.

  PMID: 29277358 RESULT

• 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.

  PMID: 31641870 RESULT

• 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.

  PMID: 12861145 RESULT

• 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.

  PMID: 33861039 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Motor Activity

Interventions

Exercise Therapy; Compression Bandages

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 9, 2022
• Study Start: November 14, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)