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

77
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
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Mar 2026Aug 2026

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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 26, 2026

Last Update Submit

March 10, 2026

Conditions

LymphedemaBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • LYMphedema Quality of Life

    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

    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

Study Arms (2)

control group

ACTIVE COMPARATOR

They will receive classic lymphedema physiotherapy.

Other: control

exercise group

EXPERIMENTAL

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

Other: controlOther: exercise

Interventions

controlOTHER

Classic lymphedema physiotherapy will be applied.

control groupexercise group
exerciseOTHER

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

exercise group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Individuals who need to restart active cancer treatment during the study period. - Being within the first 3 months after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Re-Heal Physiotherapist Sude BOYVADAOĞLU Healthy Living Center

Adana, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

Ömer ŞEVGİN

CONTACT

+905069787535omer.sevgin@uskudar.edu.tr

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 (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)