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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT03615469
Eligibility Criteria:
Inclusion Criteria:
* Adult patients who have recently been hospitalized for heart failure
* live at home
* are receiving guideline recommended pharmacologic therapy
* do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).
Exclusion Criteria:
* Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
* Cognitive or other impairment which prevents accurate application of intervention or inability to provide informed consent
* End Stage Renal Disease or receiving mechanical ventilation
* Receiving non-approved FDA-investigational agents or devices,
* Has received a heart transplant, a destination Ventricular Assist Device (LVAD), pacemaker, or implantable cardiac device
* previously used NMES (Neuromuscular electrical stimulation) or TENS (Transcutaneous electrical nerve stimulation)
* Uncontrolled arrhythmia's or 3 degree AV heart block
* are unable to correctly apply and operate the device even after instruction
* Those with wounds over area of proper placement of electrodes
* Those who are unable to speak and write English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03615469
Study Brief:
Protocol Section:
NCT03615469