Investigation of the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema.
Investigating the Effectiveness of Progressive Resistance Exercise Training in the Management of Lymphedema Developing After Breast Cancer Treatment: a Randomized Controlled Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedStudy Start
First participant enrolled
March 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2026
CompletedAugust 12, 2026
August 1, 2026
3 months
February 26, 2026
August 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of excess limb volume
Limb circumference measured with a flexible tape at 5 cm intervals from the ulnar styloid process to 40 cm proximally in both limbs. Segmental volumes calculated using the truncated cone formula and summed. Excess volume expressed as the percentage difference between the affected and unaffected limb relative to the unaffected limb volume. A lower value indicates less lymphoedema.
Baseline and 12 weeks
Secondary Outcomes (2)
LYMphedema Quality of Life
Baseline and 12 weeks
Disabilities of the Arm, Shoulder and Hand
Baseline and 12 weeks
Study Arms (2)
control group
ACTIVE COMPARATORClassic lymphoedema physiotherapy alone, twice weekly for 12 weeks (24 sessions): manual lymphatic drainage (30 min), multilayer short-stretch compression bandaging, simple lymphatic exercises (15 min) and skin-care education. No resistance exercise programme was prescribed.
exercise group
EXPERIMENTALClassic lymphoedema physiotherapy as in the control group, plus a home-based progressive resistance exercise programme for the upper limb, twice weekly for 12 weeks (24 sessions), using Thera-Band elastic resistance with band-colour progression every four weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Female, aged 30 to 60 years
- Unilateral upper-limb lymphoedema following treatment for breast cancer (surgery, chemotherapy and/or radiotherapy), diagnosed clinically by a physician
- Excess limb volume of at least 10% relative to the unaffected limb, calculated from bilateral circumferential measurements using the truncated cone formula
- At least 3 months post-surgery
- Able to tolerate compression bandaging or a compression garment
You may not qualify if:
- Within the first 3 months after surgery
- Requiring reinitiation of active cancer treatment during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center
Adana, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 41149475BACKGROUNDShamsesfandabadi 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.
PMID: 40498485BACKGROUNDXue 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.
PMID: 40859515BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sevinj RAFILI
Uskudar University
- STUDY DIRECTOR
Suzan Aydın
İstanbul Gelişim University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof.Dr.
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 4, 2026
Study Start
March 6, 2026
Primary Completion
June 15, 2026
Study Completion
August 7, 2026
Last Updated
August 12, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author