Effectiveness of a Tele-Rehabilitation-Based Exercise and Self-Lymphatic Drainage Program Supported by Self-Management for Breast Cancer-Related Lymphedema

Sponsor
Istanbul University
Study ID
NCT07794904
Status
Recruiting
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Conditions

  • Breast Cancer-Related Lymphedema
  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tele-rehabilitation-Based Exercise and Self-Lymphatic Drainage Program — OTHER
    The exercise and self-lymphatic drainage program will be performed under live online supervision.
  • Home-Based Exercise and Self-Lymphatic Drainage Program — OTHER
    The same exercise and self-lymphatic drainage program will be performed at home using an educational brochure.

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Oct 26, 2026
Completion
Nov 23, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change from Baseline in Affected Upper Extremity Volume [ Time Frame: Baseline (before starting treatment), Week 8 (end of intervention), Week 12 (one month after the end of intervention) ]

Central Contacts

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