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

23 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

46

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Serap Özgül, PhD
  • Número de telefone: +905339390803
  • E-mail: serapky@yahoo.com

Locais de estudo

  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye)
        • Aysel Özge Kemer
        • Contato:
        • Subinvestigador:
          • Elif Can Özdemir

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Complex decongestive therapy, trunk-focused exercise and kinesiology taping
Trunk-focused exercise and kinesiology taping
Outro: Complex Decongestive Therapy
Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
Outro: 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.
Outro: Kinesiology taping
Kinesiology taping will be applied bilaterally to the scalene, trapezius, and paraspinal muscles using a muscle facilitation technique twice per week.
Comparador de Placebo: Complex decongestive therapy, plasebo taping and lower extremity exercises
Lower extremity exercises and plasebo taping
Outro: Complex Decongestive Therapy
Manual lymphatic drainage, compression bandaging, remedial exercise, and skin care, is considered the gold standard treatment for lymphedema.
Outro: Lower extremity exercises
Lower extremity range of motion exercises will be performed three times per week, with 8-10 repetitions for each exercise.
Outro: Placebo taping
Placebo kinesiology taping without tension will be applied to the cervical, thoracic, and lumbar regions twice per week.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean of cervical, thoracic, and lumbar pain intensity scores
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Thoracic kyphosis angle
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hacettepe University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de agosto de 2026

Conclusão Primária (Estimado)

15 de agosto de 2027

Conclusão do estudo (Estimado)

15 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de junho de 2026

Primeira postagem (Real)

29 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FTREK26/10

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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