Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT04717050
Brief Summary:
This study is about testing whether exercise will improve fitness and lessen risk factors related to heart disease, diabetes, and obesity in Latina breast cancer survivors.
Detailed Description:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The purpose of this research is to determine whether a 16-week exercise program will improve fitness and lessen risk factors related to coronary artery disease, stroke, and type 2 diabetes in patients who have breast cancer and is sustainable for a Latina population to incorporate into their lifestyle following completion of the 16-week intervention.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants in this study will be randomly assigned into one of the study groups: Progressive Combine Training (PCT) or Attention Control.
* Progressive combined training (PCT) will be performed in 2 phases:
1. supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom.
2. unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home with weekly check-ins with trainer.
* Attention Control Group: 51 weeks home-based stretching
All participants will undergo seven blood draws and participate in nine testing visits.
Participation is expected to last 12 months for all participants.
It is expected that about 160 people will take part in this research study.
The American Cancer Society is supporting this research study by providing funding for the research study.
Study:
NCT04717050
Study Brief:
Protocol Section:
NCT04717050