NCT06491654

Physiotherapy Program Impact on Breast Cancer-Related Lymphedema

Effect of a Physiotherapy Program Based on Concurrent Strength and Moderate-to-high Intensity Aerobic Exercise Training, Along With Cohesive Bandaging, in Women With Breast Cancer-related Lymphedema.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: European University Miguel de Cervantes · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.

Detailed description

Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection andregional lymph node radiation. Clinically, it can cause pain, swelling and a decrease in the functionality of those patients who suffer from it. Moderate-high intensity strength exercise, in combination with aerobic exercise and a cohesive compressive bandage, could minimize the associated symptomatology and clinical symptoms, as well as improve various biological parameters related to tumor progression and increase the functionality of patients. Likewise, the study of the long-term effects of the treatment will make it possible to determine the chronic adaptations generated by exercise. The intervention will consist of concurrent training (strength and aerobic exercise) for all patients, whether they have BCRL or are at risk. Also, patients with BCRL will have cohesive bandaging applied at the end of the exercise session. The main objective of this study is to determine the benefits that moderate-high intensity strength training, in combination with an aerobic exercise protocol and, together with the application of a compressive bandage, generates on patients suffering from BCRL or at risk of suffering it. Through this investigation, we seek to analyze the impact of the intervention on various clinical, functional, and molecular factors. Likewise, healthy controls participants will participate in two exercise interventions and functional and molecular adaptations will be analyzed.

Conditions

• Breast Cancer Related Lymphedema

Interventions

Type	Name	Description
OTHER	12-week supervised exercise	During the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed.

Timeline

• Start date: 2024-03-11
• Primary completion: 2025-09-20
• Completion: 2025-10-10
• First posted: 2024-07-09
• Last updated: 2025-06-11

Locations

1 site across 1 country: Spain