Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

September 8, 2020 updated by: Andrey Bezdenezhnykh, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kemerovo, Russian Federation, 650002
        • Recruiting
        • Research Institute for Complex Issues of Cardiovascular Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in strength test (Dynamometer) from baseline to 12-weeks post EMS in EMS vs. controls
Time Frame: Baseline, 12 weeks after baseline
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
Time Frame: 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.
Baseline, 12 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in right ventricle diastolic function from baseline to 12-weeks post EMS in EMS vs. controls
Time Frame: Baseline, 12 weeks after baseline
Baseline, 12 weeks after baseline
Change in peak oxygen consumption, measured by spiroergometry from baseline to 12 weeks post EMS in EMS vs. controls
Time Frame: Baseline, 12 weeks after baseline
Baseline, 12 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Patients survival in EMS vs. controls
Time Frame: 12 weeks after 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
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: Time Frame: Baseline, 12 weeks after baseline
Time Frame: Baseline, 12 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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