Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema
6 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Studietype
Ingrijpend
Inschrijving (Geschat)
64
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Fatih
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Istanbul, Fatih, Turkije (Türkiye), 34093
- Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline in Affected Upper Extremity Volume
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Lymphedema Stage
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 september 2026
Primaire voltooiing (Geschat)
2 november 2026
Studie voltooiing (Geschat)
30 november 2026
Studieregistratiedata
Eerst ingediend
27 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 augustus 2026
Eerst geplaatst (Werkelijk)
31 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2026
Laatste update ingediend die voldeed aan QC-criteria
6 september 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E-29624016-050.99-3971805
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