Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

NCT ID: NCT04522609

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-11-30

Brief Summary

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.

Conditions

Sarcopenia; Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Guideline recommended pharmacologic therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

NMES group

standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation (NMES)

Intervention Type: DEVICE

NMES will carried out with four-channel myostimulator "Beurer EM80" (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session.

Interventions

Neuromuscular electrical stimulation (NMES)

NMES will carried out with four-channel myostimulator "Beurer EM80" (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

OTHER

Sponsor Role: lead

Responsible Party

Andrey Bezdenezhnykh

Senior Researcher of Comorbidity in Cardiovascular Diseases Laboratory, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrey V Bezdenezhnykh, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Complex Issues of Cardiovacular Diseases

Locations

Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Andrey V Bezdenezhnykh, PhD

Role: CONTACT

andrew22014@mail.ru

+79132971069

Facility Contacts

Andrey V Bezdenezhnykh, PhD

Role: primary

andrew22014@mail.ru

+73842644461

Other Identifiers

2020_4_19_31

Identifier Type: -

Identifier Source: org_study_id