Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status

Unknown

Conditions

Heart Failure, Systolic

Sarcopenia

Treatments

Device: Neuromuscular electrical stimulation (NMES)

Study type

Interventional

Funder types

Other

Identifiers

NCT04522609

2020_4_19_31

Details and patient eligibility

About

Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity.

In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with end-stage heart disease, listed for heart transplantation
already received standard treatment based on patient condition
are receiving guideline recommended pharmacologic therapy
able to follow protocol procedures
assigned the informed consent
do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week).

Exclusion criteria

UNOS 1a or 1b patients
already receive NMES at femoris area in last 6 weeks before admission
Patients, who have undertaken cardiac rehab within the 12 months prior to enrollment
Cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent
End Stage Renal Disease
Uncontrolled arrhythmia's or 3rd degree AV heart block
Those with wounds over area of proper placement of electrodes