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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07361393
Eligibility Criteria:
Inclusion Criteria:
* All participants must be of legal age (≥18 years) and provide signed informed consent prior to any study procedures
* Participants must have a confirmed medical diagnosis of stable cardiac disease (e.g., post-myocardial infarction, stable angina, or post-revascularization) as documented by a specialist.
* All subjects must be currently enrolled in or actively participating in a Phase III Cardiac Rehabilitation program (the maintenance phase).
* Evidence of clinical stability is required, ensuring that participants can safely perform resistance training without immediate cardiovascular contraindications.
Exclusion Criteria:
* Unstable Cardiovascular Status: Presence of unstable angina, uncontrolled cardiac arrhythmias, or severe symptomatic aortic stenosis.
* Recent Acute Events: Myocardial infarction, coronary artery bypass graft (CABG), or other major cardiac surgeries within the last 3 months (or outside the timeframe defined for Phase III eligibility).
* Uncontrolled Hypertension: Resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg despite pharmacological treatment.
* Specific Contraindications to BFR: History of deep vein thrombosis (DVT), peripheral vascular disease, or severe lymphedema in the limbs designated for cuff application.
* Musculoskeletal Limitations: Any orthopedic or neuromuscular condition that prevents the safe performance of biceps curls or leg press exercises.
* Concurrent High-Intensity Training: Participation in any other structured vigorous-intensity exercise program that could confound the results of the intervention.
* Medical Instability: Significant comorbid conditions, such as uncontrolled metabolic disease (e.g., Type 2 Diabetes with severe complications), advanced renal failure, or respiratory diseases that limit functional capacity below the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07361393
Study Brief:
Protocol Section:
NCT07361393