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

23 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

46

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean of cervical, thoracic, and lumbar pain intensity scores
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Thoracic kyphosis angle
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hacettepe University

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 sierpnia 2026

Zakończenie podstawowe (Szacowany)

15 sierpnia 2027

Ukończenie studiów (Szacowany)

15 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

23 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

29 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FTREK26/10

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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