Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
NCT ID:
NCT03523195
Eligibility Criteria:
Inclusion Criteria:
* Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
* No evidence of disease
* 1-5 years post active treatment for malignancy
* Body mass index 19 to 35
* Sedentary (\< 100 minutes of moderate intensity exercise per week)
* English adequate to complete assessments and follow exercise instructions
* Able to independently use transportation to attend 2-day a week onsite exercise training
* Access to a computer or smartphone
Exclusion Criteria:
* Current tobacco use or electronic cigarette smoker
* Pregnant
* Diabetes requiring insulin injection
* Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
* Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline
* Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:
* Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;
* Have an implanted cardiac pacemaker or other implanted cardiac device;
* Have chronic, uncontrolled hypertension as judged by the investigator;
* Have a creatinine clearance \< 45 mL/min as calculated by the Cockcroft-Gault equation;
* Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
64 Years
Study:
NCT03523195
Study Brief:
Protocol Section:
NCT03523195