Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema
2026年9月6日 更新者：İlayda Gürsoy、Istanbul University
Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema: A Single-Blind Randomized Controlled Trial
A total of 64 women, aged between 20 and 65 years, diagnosed with stage I or II breast cancer-related lymphedema and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University Istanbul Medical Faculty, will be included in our thesis study, which is planned to be prospective, randomized, and single-blind. Participants will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and written informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Participant assessment and follow-up forms will be completed before and after treatment. Participants who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention group or the control group by a computer program.
All participants will receive a face-to-face education session about breast cancer-related lymphedema, including exercise, self-lymphatic drainage, skin care, compression garment use, and self-management, together with an educational brochure. Participants in both groups will be asked to continue wearing their prescribed compression garments throughout the study. In addition to this education, the intervention group (G1) will join live Zoom sessions with the study physician three times a week for 8 weeks to perform the exercise and self-lymphatic drainage program under real-time supervision. Each session will include approximately 30 minutes of therapeutic exercises followed by 15 minutes of self-lymphatic drainage.
The control group (G2) will receive the same exercise and self-lymphatic drainage program in brochure format, including written instructions and illustrations. Participants will be asked to perform the exercise and self-lymphatic drainage program at home three times a week for 8 weeks without live online supervision.
調査の概要
状態
積極的、募集していない
条件
研究の種類
介入
入学 (推定)
64
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Fatih
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Istanbul、Fatih、トルコ（Türkiye）、34093
- Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria
- Female participants between 20 and 65 years of age
- History of unilateral breast cancer surgery including axillary lymph node dissection
- Completion of breast cancer treatments, including surgery, radiotherapy, and chemotherapy, with at least 3 months elapsed since treatment completion
- Diagnosis of stage I or stage II upper extremity lymphedema according to the International Society of Lymphology (ISL) classification
- Presence of at least 5% volume difference between the affected and unaffected upper extremities
- No history of manual lymphatic drainage, compression bandaging treatment, or structured resistance exercise program within the previous 3 months
- Ability to use a smartphone or tablet and sufficient cognitive and motor ability to participate in digital sessions
- Prescription of an appropriate compression garment for the affected extremity and regular use of the garment as recommended
Exclusion Criteria
- Presence of uncontrolled hypertension, pulmonary edema, or severe cardiovascular disease
- Presence of psychiatric or cognitive impairment that may interfere with study participation or adherence
- Presence of stage III lymphedema according to the ISL classification
- Presence of skin lesions such as papilloma or hyperkeratosis in the lymphedematous area
- History of bilateral breast cancer
- Presence of active cancer or clinical/radiological evidence of metastasis
- Presence of active infection in the affected extremity
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Intervention Group
In addition to a face-to-face education session and educational brochure, participants will receive the exercise and self-lymphatic drainage program through live Zoom sessions with the study physician three times a week for 8 weeks.
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The exercise and self-lymphatic drainage program will be performed under live online supervision.
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アクティブコンパレータ：Control Group
Face-to-face education session and educational brochure with the same exercise and self-lymphatic drainage program performed as a home-based program three times a week for 8 weeks.
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The same exercise and self-lymphatic drainage program will be performed at home using an educational brochure.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Affected Upper Extremity Volume
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
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Limb volume is an objective measure used to evaluate swelling associated with upper extremity lymphedema.
Bilateral arm circumference measurements will be obtained using a low-stretch measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle.
Bilateral upper limb volume will be calculated indirectly using the truncated cone formula.
The change from baseline in affected upper extremity volume will be evaluated as the primary outcome.
Treatment response will additionally be assessed using the excess volume difference between the affected and unaffected limbs and the percentage change in excess volume (PCEV).
Lymphedema severity will also be classified according to the excess limb volume difference as minimal (5-<20% increase), moderate (20-40% increase), and severe (>40% increase).
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Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lymphedema Stage
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Lymphedema stage will be assessed according to the International Society of Lymphology (ISL) classification system.
The ISL classification categorizes lymphedema severity into stages 0, I, II, and III based on clinical findings.
Stage 0 represents a latent or subclinical condition without evident swelling despite impaired lymphatic transport.
Stage I is characterized by early fluid accumulation that decreases with limb elevation and may include pitting edema.
Stage II involves persistent swelling with tissue changes, including fibrosis and fat deposition, with limited response to elevation.
Stage III represents advanced lymphedema with marked swelling, fibrosis, fat deposition, and skin changes.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Visual Analog Scale (VAS) for Lymphedema Symptom Severity
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention
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The Visual Analog Scale (VAS) is a commonly used assessment tool for measuring symptom intensity.
Lymphedema symptom severity will be assessed using the VAS, a simple and reproducible tool used to evaluate the intensity of subjective symptoms.
Participants will rate the severity of lymphedema-related symptoms, including fullness/tightness, heaviness, swelling, and pain in the affected extremity, on a 10-cm horizontal scale.
The scale ranges from 0 (no symptom) to 10 (the most severe symptom).
Higher scores indicate greater symptom severity.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention
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Hand Grip Strength
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Hand grip strength will be assessed using the Jamar hydraulic hand dynamometer, a commonly used and reliable tool for evaluating maximal grip force.
Participants will be seated upright with back support, hips and knees flexed at 90°, feet supported on the floor, shoulder adducted, elbow flexed at 90°, and wrist positioned in 15°-30° extension and 0°-15° ulnar deviation.
After demonstration of the measurement procedure, participants will be instructed to squeeze the dynamometer maximally for 3 seconds.
Three measurements will be performed with 1-minute intervals, and the mean value will be recorded in kg/f.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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The Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) is a self-reported questionnaire used to assess upper extremity function, disability, and symptoms.
The questionnaire consists of 11 items evaluating difficulty during physical activities, the impact of upper extremity problems on daily and social activities, sleep, pain, and numbness.
Each item is scored from 1 to 5, and the total score is converted to a scale ranging from 0 to 100.
Higher scores indicate greater disability and more severe upper extremity impairment.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm)
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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The Lymphedema Quality of Life Questionnaire - Arm (LYMQOL-Arm) is a disease-specific questionnaire developed to assess quality of life in individuals with upper extremity lymphedema.
The questionnaire consists of four domains, including function, appearance/body image, symptoms, and mood, as well as one overall quality of life item.
Each domain item is rated on a 4-point Likert scale (1 = not at all, 4 = very much), with higher scores indicating poorer quality of life.
The overall quality of life item is rated on a scale from 0 (worst quality of life) to 10 (best quality of life).
Mean scores are calculated for each domain, and domain scores together with the overall quality of life score are used for evaluation.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Breast Cancer-Related Lymphedema Self-Care Scale
時間枠：Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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The Breast Cancer-Related Lymphedema Self-Care Scale is a questionnaire developed to assess self-care behaviors in individuals with breast cancer-related lymphedema.
The scale consists of 31 items and four subdomains, which are rated using a 4-point Likert scale.
Total scores range from 31 to 124, with higher scores indicating better self-care practices.
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Baseline (before starting treatment), Week 8 (end of intervention), and Week 12 (one month after the end of intervention)
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Lymphedema Self-Management Adherence Monitoring Form
時間枠：From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period)
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The Lymphedema Self-Management Adherence Monitoring Form is a daily tracking form developed to evaluate participants' adherence to self-management practices, including exercise, self-lymphatic drainage (SLD), and compression garment use.
Participants will record whether they performed the exercise and SLD program, as well as the duration and number of sessions.
Compression garment use will be recorded based on daily usage and duration of wear (hours).
Adherence will be evaluated based on data collected throughout the 8-week intervention period and the subsequent 4-week follow-up period.
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From baseline to Week 12 (during the 8-week intervention period and 4-week follow-up period)
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Patient Satisfaction with Tele-rehabilitation Program
時間枠：Week 8 (end of intervention)
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Patient satisfaction with the tele-rehabilitation program will be assessed using a single-item 0-10 satisfaction rating scale developed by the researchers.
Participants will rate their overall satisfaction with the tele-rehabilitation program from 0 (not satisfied at all) to 10 (completely satisfied).
Higher scores indicate greater satisfaction.
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Week 8 (end of intervention)
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月7日
一次修了 (推定)
2026年11月2日
研究の完了 (推定)
2026年11月30日
試験登録日
最初に提出
2026年8月27日
QC基準を満たした最初の提出物
2026年8月27日
最初の投稿 (実際)
2026年8月31日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月6日
最終確認日
2026年8月1日
詳しくは
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