Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia; Heart Failure, Systolic
• Intervention / Treatment: Device: Neuromuscular electrical stimulation (NMES)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Recruiting
    • Research Institute for Complex Issues of Cardiovascular Diseases
    • Contact: Andrey V Bezdenezhnykh, PhD; Phone Number: +73842644461; Email: andrew22014@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Guideline recommended pharmacologic therapy
Experimental: NMES group; standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls	Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)	Baseline, 12 weeks after baseline
Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls	Participants will be instructed to move as quickly as they feel safe and comfortable over the 50-meter course for 6 minutes. As per the protocol, participants will be allowed to stop and rest if necessary.	Baseline, 12 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls	Baseline, 12 weeks after baseline
Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls	Baseline, 12 weeks after baseline

Other Outcome Measures

Outcome Measure	Time Frame
Patients survival in EMS vs. controls	12 weeks after baseline
Change in muscle rectus femoris crossectional area assessed by ultrasound from baseline to 12 weeks post EMSin EMS vs. controls	Baseline, 12 weeks after baseline
Change in muscle rectus femoris crossectional area assessed by ultrasound from baseline to 12 weeks post EMSin EMS vs. controls	Time Frame: Baseline, 12 weeks after baseline

Collaborators and Investigators

• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: heart failure; sarcopenia; neuromuscular electric stimulation; skeletal muscles; heart transplantation listing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Heart Failure; Sarcopenia; Heart Failure, Systolic
• Other Study ID Numbers: 2020_4_19_31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No