Effects of Core-Focused Exercise Training and Kinesiology Taping in Women With Breast Cancer-Related Lymphedema
23 de junio de 2026 actualizado por: SERAP ÖZGÜL, Hacettepe University
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
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
46
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Serap Özgül, PhD
- Número de teléfono: +905339390803
- Correo electrónico: serapky@yahoo.com
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye)
- Aysel Özge Kemer
-
Contacto:
- Aysel Özge Kemer
- Número de teléfono: +905327325478
- Correo electrónico: ozgetekeli@gmail.com
-
Sub-Investigador:
- Elif Can Özdemir
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Complex decongestive therapy, trunk-focused exercise and kinesiology taping
Trunk-focused exercise and kinesiology taping
|
Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
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.
Kinesiology taping will be applied bilaterally to the scalene, trapezius, and paraspinal muscles using a muscle facilitation technique twice per week.
|
|
Comparador de placebos: Complex decongestive therapy, plasebo taping and lower extremity exercises
Lower extremity exercises and plasebo taping
|
Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
Lower extremity range of motion exercises will be performed three times per week, with 8-10 repetitions for each exercise.
Placebo kinesiology taping without tension will be applied to the cervical, thoracic, and lumbar regions twice per week.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean of cervical, thoracic, and lumbar pain intensity scores
Periodo de tiempo: Change in mean cervical, thoracic, and lumbar pain intensity scores from baseline to the end of the third week.
|
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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Thoracic kyphosis angle
Periodo de tiempo: Change in thoracic kyphosis angle from baseline to the end of the third week.
|
Thoracic kyphosis and lumbar lordosis will be assessed using a flexicurve device.
With the participant in a relaxed standing posture, the assessor will identify and mark the C7-T12 and L1-S2 spinous processes by palpation.
The flexicurve will then be molded along the spine and its contour transferred onto paper.
The flexicurve index and kyphosis angle will then be calculated using standard geometric and trigonometric formulas
|
Change in thoracic kyphosis angle from baseline to the end of the third week.
|
|
Lumbar lordosis angle
Periodo de tiempo: Change in lumbar lordosis angle from baseline to the end of the third week.
|
Thoracic kyphosis and lumbar lordosis will be assessed using a flexicurve device.
With the participant in a relaxed standing posture, the assessor will identify and mark the C7-T12 and L1-S2 spinous processes by palpation.
The flexicurve will then be molded along the spine and its contour transferred onto paper.
The flexicurve index and kyphosis angle will then be calculated using standard geometric and trigonometric formulas
|
Change in lumbar lordosis angle from baseline to the end of the third week.
|
|
Pain pressure threshold
Periodo de tiempo: Change in pain pressure threshold from baseline to the end of the third week.
|
Pain pressure threshold will be assessed using an algometer.
Measurements will be taken three times from the midpoint of the upper trapezius, thoracic, and lumbar paraspinal muscles with participants in a seated position, and the mean value will be recorded.
|
Change in pain pressure threshold from baseline to the end of the third week.
|
|
Patient assessment of Postural Awareness
Periodo de tiempo: Change in postural awareness from baseline to the end of the third week.
|
Postural awareness will be evaluated using the Postural Awareness Scale (PAS).
This self-reported Likert-type scale consists of 12 items, each rated from 1 (not at all true for me) to 7 (completely true for me), and is designed to assess an individuals awareness of their own body posture.
|
Change in postural awareness from baseline to the end of the third week.
|
|
Upper extremity functionality
Periodo de tiempo: Change in upper extremity functionality from baseline to the end of the third week.
|
Upper extremity functionality will be assessed using the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH).
This patient-reported outcome measure consists of 11 items evaluating physical function and symptoms of the upper extremity, each with five response options, and yields a score ranging from 0 to 100
|
Change in upper extremity functionality from baseline to the end of the third week.
|
|
Upper Limb Functionality
Periodo de tiempo: Change in functionality from baseline to the end of the third week.
|
Functionality will be assessed using the Lymphedema Functioning, Disability and Health Questionnaire for the Upper Limb (Lymph-ICF-UL).
This descriptive and evaluative tool consists of 29 items assessing impairments, activity limitations, and participation restrictions in patients with lymphedema.
The questionnaire is divided into five domains (physical function, mental function, household activities, mobility activities, and life/social activities) and each item is scored on a scale from 0 to 10.
|
Change in functionality from baseline to the end of the third week.
|
|
Patient assessment of Quality of life
Periodo de tiempo: Change in quality of life from baseline to the end of the third week.
|
Quality of life will be assessed using the SF-12 Health Survey.
This scale, developed to evaluate individuals' physical and mental health status, consists of 12 items and includes two main components: physical and mental health.
The total score ranges from 0 to 100.
|
Change in quality of life from baseline to the end of the third week.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de agosto de 2026
Finalización primaria (Estimado)
15 de agosto de 2027
Finalización del estudio (Estimado)
15 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2026
Publicado por primera vez (Actual)
29 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FTREK26/10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .