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

Official title

Effects of Core-Focused Exercise Training and Kinesiology Taping Combined With Complex Decongestive Physiotherapy on Posture, Pain, Function, and Quality of Life in Women With Breast Cancer-Related Lymphedema

Overview

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.

Interventions

• Other Complex Decongestive Therapy
  Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
• Other Trunk Focused exercises
  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.
• Other Kinesiology taping
  Kinesiology taping will be applied bilaterally to the scalene, trapezius, and paraspinal muscles using a muscle facilitation technique twice per week.
• Other Lower extremity exercises
  Lower extremity range of motion exercises will be performed three times per week, with 8-10 repetitions for each exercise.
• Other Placebo taping
  Placebo kinesiology taping without tension will be applied to the cervical, thoracic, and lumbar regions twice per week.

Primary outcome measures

• Mean of cervical, thoracic, and lumbar pain intensity scores [Time frame: Change in mean cervical, thoracic, and lumbar pain intensity scores from baseline to the end of the third week.]

Secondary outcome measures (7)

• Thoracic kyphosis angle [Time frame: Change in thoracic kyphosis angle from baseline to the end of the third week.]
• Lumbar lordosis angle [Time frame: Change in lumbar lordosis angle from baseline to the end of the third week.]
• Pain pressure threshold [Time frame: Change in pain pressure threshold from baseline to the end of the third week.]
• Patient assessment of Postural Awareness [Time frame: Change in postural awareness from baseline to the end of the third week.]
• Upper extremity functionality [Time frame: Change in upper extremity functionality from baseline to the end of the third week.]
• Upper Limb Functionality [Time frame: Change in functionality from baseline to the end of the third week.]
• Patient assessment of Quality of life [Time frame: Change in quality of life from baseline to the end of the third week.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Aysel Özge Kemer — Ankara

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07673939 · FTREK26/10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗