NCT07448467

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

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 COMPARATOR

Classic 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.

Other: control

exercise group

EXPERIMENTAL

Classic 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.

Other: controlOther: exercise

Interventions

controlOTHER

Classic lymphedema physiotherapy will be applied.

control groupexercise group

In addition to classic lymphedema physiotherapy, a progressive resistance exercise training program will be implemented.

exercise group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

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: 41149475BACKGROUND
  • 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.

    PMID: 40498485BACKGROUND
  • 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.

    PMID: 40859515BACKGROUND

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sevinj RAFILI

    Uskudar University

    STUDY CHAIR
  • Suzan Aydın

    İstanbul Gelişim University

    STUDY DIRECTOR

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

Locations