Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Not Applicable

• Conditions: Sarcopenia; Heart Failure, Systolic
• Interventions: Device: Neuromuscular electrical stimulation (NMES)

• Registration Number: NCT04522609
• Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-21
• Status Verified: 2020-09
• Study Start: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10
• Primary Completion: 2022-07
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES group	Neuromuscular electrical stimulation (NMES)	standard protocol for cardiac rehabilitation plus neuromuscular electrical stimulation (NMES)

Primary Outcome Measures

Name	Time	Method
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls	Baseline, 12 weeks after baseline	Strength Assessment will be done using a portable hand-held dynamometer (Lafayette Manual Muscle Test System 001165)
Change in 6-minute walk test distance from baseline to 12-weeks post EMS in EMS vs. controls	Baseline, 12 weeks after baseline	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Institute for Complex Issues of Cardiovascular Diseases; 🇷🇺 Kemerovo, Russian Federation