Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491654
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-22
Brief Title:
Physiotherapy Program Impact on Breast Cancer-Related Lymphedema
Sponsor:
European University Miguel de Cervantes
Organization:
European University Miguel de Cervantes
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None