Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Neuromuscular Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, 6 minute walk test, DXA, Double Blinded randomized control trial, ActivPal, EMPI Continuum Device
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.
Sites / Locations
- Indiana University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Neuromusclar electrical stimulation
Transcutaneous electrical stimulation
NMES will be set up with the machine on simultaneous large muscle atrophy setting with 500 ohm with peak of 50 volts, the "self-adhesive electrodes positioned on the thighs approximately 5 cm below the inguinal fold and 3 cm above the upper patella border" as described by Gobbo. When applying the stimulation, the intensity will be gradually increased from an intermittent tingling until a gentle pumping sensation is felt. Participants will direct the amount of stimulation acceptable on both thighs to improve acceptance of the modality. It is expected that tolerance will develop and intensity will increase over time.
For the Sham group, electrodes will follow the same landmarks, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation