Effects of Core-Focused Exercise Training and Kinesiology Taping in Women With Breast Cancer-Related Lymphedema

NCT07673939 | Not Yet Recruiting

• 1 other identifier: FTREK26/10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate the effects of trunk- focused exercise training and kinesiology taping, in addition to standard lymphedema treatment (complex decongestive therapy-CDT) on posture, pain, functionality and quality of life in women with breast cancer related lymphedema. This study is designed as a randomized placebo-controlled trial. Lymphedema negatively affects the musculoskeletal system, leading to shoulder girdle muscle imbalances, cervical and thoracolumbar pain, scapular dysfunction and spinal postural alterations. Although CDT is considered the gold standard for edema management, its effects have primarily been evaluated in terms of edema reduction and symptom control, and there is limited evidence regarding its impact on posture, musculoskeletal symptoms, and quality of life, as well as the potential effects of prolonged compression bandaging applied during the intensive phase on these systems. Trunk-focused exercise training is expected to improve spinal stability, mobility and postural control, while kinesiology taping may help alleviate musculoskeletal symptoms by providing proprioceptive input and mechanical support. By combining these interventions, this study aims to provide a comprehensive rehabilitation approach targeting both physical and functional impairments. If additional improvements in posture, pain, function, and quality of life are observed compared to a control group receiving CDT combined with lower extremity exercise and placebo taping, these findings will support the added value of a multimodal rehabilitation approach beyond standard care. The findings of this randomized placebo-controlled trial are expected to contribute to the literature by providing evidence for a comprehensive and holistic treatment approach in breast cancer-related lymphedema and to support the integration of trunk-focused exercise training and kinesiology taping into routine clinical practice. To the best of our knowledge, there is currently no randomized placebo-controlled study investigating the effects of trunk-focused exercise training and kinesiology taping in addition to CDT on posture, pain, functionality, and quality of life.

Conditions

Breast Cancer Related Lymphedema

Outcome Measures

Primary Outcomes (1)

• Mean of cervical, thoracic, and lumbar pain intensity scores

  Pain intensity in the cervical, thoracic, and lumbar regions will be assessed using the Numeric Rating Scale (NRS), and the mean of these scores will be calculated; participants will rate their pain from 0 (no pain) to 10 (worst imaginable pain).

  Change in mean cervical, thoracic, and lumbar pain intensity scores from baseline to the end of the third week.

Secondary Outcomes (7)

• Thoracic kyphosis angle

  Change in thoracic kyphosis angle from baseline to the end of the third week.

• Lumbar lordosis angle

  Change in lumbar lordosis angle from baseline to the end of the third week.

• Pain pressure threshold

  Change in pain pressure threshold from baseline to the end of the third week.

• Patient assessment of Postural Awareness

  Change in postural awareness from baseline to the end of the third week.

• Upper extremity functionality

  Change in upper extremity functionality from baseline to the end of the third week.

Study Arms (2)

Complex decongestive therapy, trunk-focused exercise and kinesiology taping

EXPERIMENTAL

Trunk-focused exercise and kinesiology taping

Other: Complex Decongestive Therapy; Other: Trunk Focused exercises; Other: Kinesiology taping

Complex decongestive therapy, plasebo taping and lower extremity exercises

PLACEBO COMPARATOR

Lower extremity exercises and plasebo taping

Other: Complex Decongestive Therapy; Other: Lower extremity exercises; Other: Placebo taping

Interventions

Complex Decongestive Therapy OTHER

Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.

Complex decongestive therapy, plasebo taping and lower extremity exercises; Complex decongestive therapy, trunk-focused exercise and kinesiology taping

Trunk Focused exercises OTHER

Postural and spinal stabilization exercises will be performed three times per week in supine, side-lying, quadruped, sitting, and standing positions, with 8-10 repetitions for each exercise.

Complex decongestive therapy, trunk-focused exercise and kinesiology taping

Kinesiology taping OTHER

Kinesiology taping will be applied bilaterally to the scalene, trapezius, and paraspinal muscles using a muscle facilitation technique twice per week.

Complex decongestive therapy, trunk-focused exercise and kinesiology taping

Lower extremity exercises OTHER

Lower extremity range of motion exercises will be performed three times per week, with 8-10 repetitions for each exercise.

Complex decongestive therapy, plasebo taping and lower extremity exercises

Placebo taping OTHER

Placebo kinesiology taping without tension will be applied to the cervical, thoracic, and lumbar regions twice per week.

Complex decongestive therapy, plasebo taping and lower extremity exercises

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 65 years
• Diagnosis of stage 1-2 lymphedema according to the International Society of Lymphology classification system
• History of radical surgery due to primary breast cancer, with at least 6 months elapsed since surgery
• Completion of cancer treatments such as chemotherapy and / or radiotherapy
• Presence of pain with a score of ≥3 on the Numeric Rating Scale (NRS) in at least one of the lumbar, thoracic, or cervical regions
• No cooperation problems in completing the study questionnaires

You may not qualify if:

• Body mass index (BMI) \>30 kg/m²
• Presence of active infection
• Presence of active malignancy or metastasis
• Presence of neurological disease
• History of bilateral breast cancer
• Presence of extremity deformity, scoliosis, cauda equina syndrome, or history of whiplash injury
• Presence of motor or sensory neurological deficits (to be clinically assessed by manual muscle testing and superficial sensory examination)
• History of spinal surgery
• Presence of any spinal pathology

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Aysel Özge Kemer

Ankara, Turkey (Türkiye)

Location

Related Publications (16)

• Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.

  PMID: 32521126 BACKGROUND

• Greendale GA, Nili NS, Huang MH, Seeger L, Karlamangla AS. The reliability and validity of three non-radiological measures of thoracic kyphosis and their relations to the standing radiological Cobb angle. Osteoporos Int. 2011 Jun;22(6):1897-905. doi: 10.1007/s00198-010-1422-z. Epub 2010 Oct 12.

  PMID: 20938766 BACKGROUND

• Foldi E. The treatment of lymphedema. Cancer. 1998 Dec 15;83(12 Suppl American):2833-4. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-3.

  PMID: 9874407 BACKGROUND

• 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 BACKGROUND

• Thompson B, Gaitatzis K, Janse de Jonge X, Blackwell R, Koelmeyer LA. Manual lymphatic drainage treatment for lymphedema: a systematic review of the literature. J Cancer Surviv. 2021 Apr;15(2):244-258. doi: 10.1007/s11764-020-00928-1. Epub 2020 Aug 15.

  PMID: 32803533 BACKGROUND

• Corum M, Basoglu C, Korkmaz MD, Yildirim MA, Ones K. Effectiveness of Combined Complex Decongestive Therapy and Resistance Exercises in the Treatment of Lymphedema Associated with Breast Cancer and the Effect of Pain on Treatment Response. Lymphat Res Biol. 2021 Aug;19(4):383-390. doi: 10.1089/lrb.2020.0099. Epub 2021 Jan 15.

  PMID: 33449865 BACKGROUND

• Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14.

  PMID: 21493748 BACKGROUND

• Kasawara KT, Mapa JMR, Ferreira V, Added MAN, Shiwa SR, Carvas N Jr, Batista PA. Effects of Kinesio Taping on breast cancer-related lymphedema: A meta-analysis in clinical trials. Physiother Theory Pract. 2018 May;34(5):337-345. doi: 10.1080/09593985.2017.1419522. Epub 2018 Jan 8.

  PMID: 29308967 BACKGROUND

• Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014.

  PMID: 24816774 BACKGROUND

• Surmeli M, Cinar Ozdemir O. The effect of upper limb lymphedema in posture of patients after breast cancer surgery. J Back Musculoskelet Rehabil. 2022;35(4):829-837. doi: 10.3233/BMR-210049.

  PMID: 34744068 BACKGROUND

• Pirincci CS, Dalyan M, Delialioglu SU, Celenay ST. Effects of scapulothoracic stabilization exercises on scapular function, posture, and balance in lymphedema after mastectomy: a randomized controlled trial. Women Health. 2023 Apr;63(4):251-265. doi: 10.1080/03630242.2023.2178836. Epub 2023 Feb 22.

  PMID: 36814100 BACKGROUND

• Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.

  PMID: 35730511 BACKGROUND

• Kostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28.

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  PMID: 15866967 BACKGROUND

• Cramer H, Mehling WE, Saha FJ, Dobos G, Lauche R. Postural awareness and its relation to pain: validation of an innovative instrument measuring awareness of body posture in patients with chronic pain. BMC Musculoskelet Disord. 2018 Apr 6;19(1):109. doi: 10.1186/s12891-018-2031-9.

  PMID: 29625603 BACKGROUND

• Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.

  PMID: 25239073 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Serap Özgül, PhD

CONTACT

+905339390803; serapky@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)