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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Body mass index (BMI) >30 kg/m²

Presence of active infection

Presence of active malignancy or metastasis

Presence of neurological disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Complex Decongestive Therapy

    Other intervention

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

  • Trunk Focused exercises

    Other intervention

    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

    Other intervention

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

  • Lower extremity exercises

    Other intervention

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

  • Placebo taping

    Other intervention

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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Complex decongestive therapy, trunk-focused exercise and kinesiology tapingExperimental treatment 3 interventions
Group B: Complex decongestive therapy, plasebo taping and lower extremity exercisesPlacebo comparator 3 interventions

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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