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
| Registry | NCT07794904 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 64 (Estimated) |
| Sponsor | Istanbul University (Other) |
| Conditions | Breast Cancer-Related Lymphedema, Lymphedema |
| Interventions | Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program, Home-Based Exercise and Self-Lymphatic Drainage Program (Other) |
| Dates | start 2026-09-07, primary completion 2026-11-02 (estimated), completion 2026-11-30 (estimated), first posted 2026-08-31, last updated 2026-09-09 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer-Related Lymphedema All trials for Lymphedema All trials of Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program All trials of Home-Based Exercise and Self-Lymphatic Drainage Program
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Group | Experimental | Other: Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program | 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. |
| Control Group | Active comparator | Other: Home-Based Exercise and Self-Lymphatic Drainage Program | 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. |
Sex: Female, ages: 20 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Istanbul, Fatih | Turkey (Türkiye) |