- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448467
Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
March 10, 2026 updated by: Doç.Dr.Ömer Şevgin, Uskudar University
Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
This study aims to investigate the effect of progressive resistance exercise training on the clinical findings and functional outcomes of lymphedema in individuals who develop upper extremity lymphedema after breast cancer treatment (surgery, chemotherapy and/or radiotherapy).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a randomized controlled trial.
Volunteers participating in the study will consist of individuals who have developed lymphedema after breast cancer and who agree to participate in the study.
Volunteer female participants will be divided into 2 groups of equal numbers.
Participants in the control group will receive lymphedema treatment, while participants in the exercise group will perform progressive resistance upper extremity exercises at home, 2 days a week for 12 weeks.
All exercises will be performed with compression bandages.
All participants will be evaluated before and after treatment using a hand dynamometer, the Disabilities of the Arm, Shoulder and Hand Scale, and the Lymphedema Quality of Life Questionnaire-Arm.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
-
Adana, Turkey (Türkiye)
- Recruiting
- Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center
-
Contact:
- Sevinj RAFILI
- Phone Number: +905411127284
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- Being between 18 and 60 years of age.
- Being included in the study 3 months after undergoing surgery.
- Being able to tolerate compression bandages or compression garments.
Exclusion criteria:
- Individuals who need to restart active cancer treatment during the study period. - Being within the first 3 months after surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
They will receive classic lymphedema physiotherapy.
|
Classic lymphedema physiotherapy will be applied.
|
|
Experimental: exercise group
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
|
Classic lymphedema physiotherapy will be applied.
In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LYMphedema Quality of Life
Time Frame: 14 weeks
|
The Lymphedema Quality of Life Questionnaire, a validated disease-specific QoL tool, was also administered at baseline and at day 28.
Overall QoL is scored on a single item by the patient on a scale of 1-10.
|
14 weeks
|
|
Disabilities of the Arm, Shoulder and Hand
Time Frame: 14 weeks
|
Validated outcome measure that asks an individual to self-report about the ability to perform certain upper limb activities.
Questions are responded on a 5-point Likert scale.
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sevinj RAFILI, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leon-Diaz R, Medina-Otero A. Prevention and Treatment of Postmastectomy Lymphedema: A Physiotherapy Perspective. Curr Oncol. 2025 Oct 3;32(10):555. doi: 10.3390/curroncol32100555.
- Shamsesfandabadi P, Shams Esfand Abadi M, Yin Y, Carpenter DJ, Peluso C, Hilton C, Coopey SB, Gomez J, Beriwal S, Champ CE. Resistance Training and Lymphedema in Breast Cancer Survivors. JAMA Netw Open. 2025 Jun 2;8(6):e2514765. doi: 10.1001/jamanetworkopen.2025.14765.
- Xue T, Zhang L, Zhang D. Exercise-based interventions for postoperative rehabilitation in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2025 Aug 22;104(34):e43705. doi: 10.1097/MD.0000000000043705.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 4, 2026
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar96
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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