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.
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;
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;
Parallel
Exercise
BehavioralParticipants randomly allocated to the intervention group will engage in a 12-week combined exercise program, supervised by an accredited exercise physiologist. Sessions will comprise an aerobic component and a resistance component. Exercise progression will be individualized based on participants' tolerance.
Educational Sessions
BehavioralParticipants allocated to both intervention and control groups will attend monthly educational sessions on exercise, nutrition, and other essential health-related topics.
Bioelectrical Impedance Spectroscopy - Lymphedema Index
To monitor tissue changes associated with BCRL, the ECW ratio will be assessed using BIS (Impedimed, SFB7, Pinkenba, Queensland, Australia). This method helps detect specific alterations in extracellular fluid containing lymph. Participants will be asked to lie down for 10 minutes, with their arms apart from their trunk, palms facing down, and legs apart, on a non-conductive surface. After cleaning the skin and removing all metals, electrodes will be placed on the hands and feet according to the manufacturer's instructions, aligning the sensing electrodes with the ulnar styloid and malleolus. Measurements will be taken on both the affected and unaffected upper limbs, and the Lymphedema Index (L-Dex) ratio will be calculated (unaffected limb impedance divided by the affected limb impedance). The L-Dex ratio is usually considered normal between -10.0 to 10.0. A score above 10.0 or an increase greater than 10 from baseline is indicative of potential BCRL.
Range of motion
A goniometer will be used to assess active shoulder flexion and abduction with the participants in a standing position and the elbow fully extended. Each movement will be measured three times, and the average of these measurements will be calculated. Assessments will be conducted on both affected and unaffected upper limbs.
Anthropometric Measurements
Participants will be weighed wearing minimal clothing and no shoes. Height will be taken with a stadiometer (Seca, Hamburg, Germany) and following standardized procedures. Body mass index will be calculated by dividing weight (in kilograms) by the square of height (in meters).
Arm Circumferences
Arm circumferences of the affected and unaffected upper limbs will be measured with the arm positioned at 90° forward flexion using a soft tape measure, beginning at the midpoint of the ulna styloid ("0 cm" mark) and 10 cm intervals up to 40 cm proximal to the ulna styloid. Comparisons between affected and unaffected limbs will provide a quantitative assessment of lymphedema and allow for monitoring changes throughout the intervention.
Dual-energy X-ray Absorptiometry (DXA)
Participants will perform a whole-body DXA scan (Hologic Horizon DXA System, software QDR for Windows version 12.4, Waltham, USA) according to standardized procedures (ref). This equipment measures X-ray attenuation by pulsing between 70 and 140 kV in sync with the line frequency for each pixel in the scanned image. The same technician will position the participants, conduct the scan, and perform the analysis. DXA measurements will include whole-body and regional fat mass (FM) and fat-free mass (FFM). The same researcher will conduct all assessments and analysis to minimize inter-tester variation.
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