Eligibility Module

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 @ 2:52 PM
Ignite Modification Date: 2025-12-24 @ 2:52 PM
NCT ID: NCT03580759
Eligibility Criteria: Inclusion Criteria for Participants: * age \>19 years * diagnosis of advanced HF and a minimum of one additional co-occurring chronic condition * undergoing evaluation for left ventricular assist device implantation or heart transplant * medical clearance from a heart failure cardiologist in the Nebraska Medicine Advanced HF Clinic. * the ability to speak and understand English Inclusion Criteria for Caregivers: * age\>19 years * the ability to speak and understand English Exclusion Criteria for Participants: * cognitive impairment (Montreal Objective Cognitive Assessment39 \[MoCA\] \< 26), -neuromuscular or orthopedic impairment that would preclude low-intensity physical activity * unwillingness to complete two supervised sessions in the clinical setting, and one in the home setting * ongoing inotrope therapy. (Exercise is discouraged during inotrope therapy.) * inability to pass a Wii Fit Balance Board safety screen (prior to randomization in Phase 2) Exclusion criteria for Caregivers: * Unwillingness to participate in the supervised exergaming training sessions * Unwillingness to participate in final qualitative interview
Healthy Volunteers: False
Sex: ALL
Minimum Age: 19 Years
Study: NCT03580759
Study Brief:
Protocol Section: NCT03580759