Combined Exercise Effects in Breast Cancer-related Lymphedema

NCT07365618 | Not Yet Recruiting

• 1 other identifier: LYMFIT_2025
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer-Related Lymphedema

Keywords

Breast Cancer; Exercise; Fluid Shifts; Edema; Bioelectrical Impedance Analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (21)

• Range of motion

  3 months

• Anthropometric Measurements

  3 months

• Arm Circumferences

  3 months

• Dual-energy X-ray Absorptiometry (DXA)

  3 months

• Dilution Techniques

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will participate in supervised combined exercise sessions. Additionally, participants will engage in monthly educational sessions.

Behavioral: Exercise; Behavioral: Educational Sessions

Control Group

ACTIVE COMPARATOR

The control group will participate in monthly educational sessions.

Behavioral: Educational Sessions

Interventions

Exercise BEHAVIORAL

Participants 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.

Experimental Group

Educational Sessions BEHAVIORAL

Participants allocated to both intervention and control groups will attend monthly educational sessions on exercise, nutrition, and other essential health-related topics.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculdade de Motricidade Humana: lead

Study Sites (1)

Faculdade de Motricidade Humana

Lisbon, Portugal

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Motor Activity; Edema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rúben Francisco, PhD

  Polytechnic Institute of Rio Maior

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Bernardino, PhD Student

CONTACT

+351966636871; afvbernardino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: January 26, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)