Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema
6 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
64
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Fatih
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Istanbul, Fatih, Turchia (Türkiye), 34093
- Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from Baseline in Affected Upper Extremity Volume
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Lymphedema Stage
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 settembre 2026
Completamento primario (Stimato)
2 novembre 2026
Completamento dello studio (Stimato)
30 novembre 2026
Date di iscrizione allo studio
Primo inviato
27 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 agosto 2026
Primo Inserito (Effettivo)
31 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 settembre 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- E-29624016-050.99-3971805
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .