Clinical trial · Interventional
Combined Exercise Effects in Breast Cancer-related Lymphedema
The Impact of Combined Exercise on Lymphedema, Body Composition, Muscle Strength, and Quality of Life in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer-related lymphedema (BCRL) is a common and debilitating condition that affects quality of life, mobility, and well-being. While exercise was once thought to worsen symptoms, current evidence suggests it may improve lymphatic function and symptom management. The LymFit project will test a 12-week combined exercise program (aerobic + resistance) in breast cancer survivors with BCRL compared to usual care. This investigation aims to unravel the effects of a combined exercise program on BCRL management. A 12-week randomized controlled trial will be conducted with two arms: a combined exercise intervention (strength + aerobic training) and a control group. The LymFit project primarily aims to assess the effects of 12 weeks of combined exercise on L-Dex in BCRL patients. Secondary objectives include evaluating exercise's effects on i) ECW:ICW ratio (dilution techniques); ii) Body composition (dual-energy X-ray absorptiometry), handgrip strength (dynamometry), cardiorespiratory fitness, quality of life, arm disability, anxiety, depression (questionnaires), and inflammatory profile (blood analysis). The project also examines acute exercise (pre- to post-session) responses on iii) Lymphedema (L-Dex) and iv) Fluid shifts (ultrasound muscle thickness + PV measurement). By integrating clinical outcomes with mechanistic evaluations, this randomized controlled trial seeks to generate evidence-based recommendations for exercise in BCRL management and improve understanding of lymphatic fluid dynamics in this population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer-Related Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Sessions | Behavioral | — | UNRESOLVED |
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- The experimental group will participate in supervised combined exercise sessions. Additionally, participants will engage in monthly educational sessions.
- interventionNames
- Behavioral: Exercise
- Behavioral: Educational Sessions
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- The control group will participate in monthly educational sessions.
- interventionNames
- Behavioral: Educational Sessions
Primary outcomes (1)
- measure
- Bioelectrical Impedance Spectroscopy - Lymphedema Index
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older; * Undergone breast cancer surgery with removal of at least one lymph node; * Clinical diagnosis of stable unilateral breast cancer-related lymphedema; * Willing and able to engage in exercise; * Have not participated in a structured exercise program in the previous 6 months; * Medical clearance to participate in the study. Exclusion Criteria: * Unstable lymphedema (therapist-delivered treatment and more than one arm infection requiring antibiotics in the past 3 months); * Undergoing radiotherapy or chemotherapy by infusion for breast cancer; * Bilateral lymphedema; * Primary lymphedema; * Uncontrolled heart disease (e.g., uncontrolled coronary heart disease, heart failure, uncontrolled hypertension); * Type II diabetes; * Psychological disorders (e.g., Alzheimer's, dementia, Parkinson's); * Significant physical disabilities; * Pregnancy and/or breastfeeding; * Kidney disease.
References
Publications (0)
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