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Not yet recruitingNCT07673939Updated Jun 29, 2026

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

An interventional study of Complex Decongestive Therapy and Trunk Focused exercises in Breast Cancer Related Lymphedema, sponsored by Hacettepe University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer Related Lymphedema
03

In context

Breast Cancer Lymphedema

148 studies on the registry are indexed under Breast Cancer Lymphedema; 44 are open to participants now.

This study's planned enrollment of 46 is close to the median of 50 across 119 interventional studies indexed under Breast Cancer Lymphedema.

Browse Breast Cancer Lymphedema studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Complex decongestive therapy, trunk-focused exercise and kinesiology taping

    Trunk-focused exercise and kinesiology taping

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

  • Placebo comparator
    Complex decongestive therapy, plasebo taping and lower extremity exercises

    Lower extremity exercises and plasebo taping

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

Interventions

  • OtherComplex Decongestive Therapy

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

  • OtherTrunk 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.

  • OtherKinesiology taping

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

  • OtherLower extremity exercises

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

  • OtherPlacebo taping

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

06

What researchers measure

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).

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

Secondary outcomes

  1. Thoracic kyphosis angle

    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

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

  2. Lumbar lordosis angle

    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

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

  3. Pain pressure threshold

    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.

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

  4. Patient assessment of Postural Awareness

    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.

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

  5. Upper extremity functionality

    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

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

  6. Upper Limb Functionality

    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.

    Time frame: Change in functionality from baseline to the end of the third week.

  7. Patient assessment of Quality of life

    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.

    Time frame: Change in quality of life from baseline to the end of the third week.

07

Study locations

1 site
  • Aysel Özge Kemer
    Ankara, Turkey (Türkiye)
    • Aysel Özge Kemer · Contact · ozgetekeli@gmail.com · +905327325478
    • Elif Can Özdemir · Sub investigator
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 29308967 ↗
  • 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. PubMed 24816774 ↗
  • 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. PubMed 34744068 ↗
  • 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. PubMed 36814100 ↗
  • 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. PubMed 35730511 ↗
  • 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. PubMed 27390404 ↗
  • 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. PubMed 15866967 ↗
  • 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. PubMed 29625603 ↗
  • 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. PubMed 25239073 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07673939
Lead sponsor
Hacettepe University
Responsible party
SERAP ÖZGÜL (Prof.Dr, Hacettepe University) — Principal investigator
First posted
Jun 29, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Serap Özgül, PhD
Contact
serapky@yahoo.com
+905339390803

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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