Electrical Muscle Stimulation in Congestive Heart Failure

April 11, 2021 updated by: Nisha Arenja, Kantonsspital Olten

Electrical Muscle Stimulation in Severely Deconditioned Congestive Heart Failure Patients- a Prospective, Randomized, Controlled Trial

This trial is to evaluate two types of electrical muscle Stimulation (EMS) stimulation (low intensity "conventional stimulation" vs. high intensity "Russian" stimulation) of legs in comparison with a control group without EMS in a cohort of elderly patients with severe deconditioning after CHF decompensation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Congestive heart failure (CHF) is increasingly prevalent worldwide and is associated with significant morbidity and mortality. Poor exercise capacity is well known as a risk factor for poor prognosis. The deconditioning is mainly associated with a decrease in leg muscle mass and loss of leg strength as well as loss of muscle endurance. This affects especially elderly patients. To improve this condition in CHF electrical muscle stimulation (EMS) is a suitable method of training, which hardly affects the heart. However, most EMS existing stimulation protocols are uncomfortable and not user-friendly, especially for elderly patients. The Russian space medicine has many years' experience in specific EMS stimulation protocols, which are well tolerated by cosmonauts for hours even during working activities. Therefore, a research project has been established between the Russian Academy of Sciences (Laboratory for Biomedical Problems) and the ARTORG Research Center for Biomedical Engineering to study the effects of new developed EMS procedures in elderly persons.

Aims:

The aim of trial is to evaluate two types of EMS stimulation (low intensity "conventional stimulation" vs. high intensity "Russian" stimulation) of legs in comparison with a control group without EMS in a cohort of elderly patients with severe deconditioning after CHF decompensation.

METHOTOLOGY:

This prospective, randomized controlled study will use commercially available electronic stimulator devices (Medel GmbH, Hamburg, Germany) for EMS. For the "Russian" stimulation, an especial developed stimulator (Amplidin-EST No.5) will be used for frequency modulation of the stimulation impulse, which is supposed to make stimulation sensation more comfortable. Supervised EMS training will be performed 5 times per week (weekdays) during 30 minutes over a period of 6 weeks in elderly deconditioned CHF patients, starting at the Kantonsspital Olten during the hospitalisation and continued at home. We will include 20 patients in each group (20 in control group, 20 in low intensity "conventional group and 20 in high intensity "Russian" group). The control group was preformed to exclude an attention bias in the study results. The primary endpoint of the study is the difference in maximum oxygen uptake (peak VO2) and in 6 minutes walking distance between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control). The follow-up period is planned for 2 years.

POTENTIAL SIGNIFICANCE:

Exercise capacity and quality of life in severely deconditioned patients with CHF is poor and life expectancy is low. While the possibilities to improve the poor condition and function of the heart by pharmaceutical therapies are limited, there is potential to improve the condition of the peripheral muscles by exercise training. However, a successful aerobic training is rarely feasible in these patients. Therefore, EMS training may prove to be ideal tool to improve leg muscle mass and function of elderly patients. Because, CHF patients do not tolerate most of the existing EMS stimulation protocols, we have developed a new EMS stimulation protocol. The application is virtually painless and therefore well tolerated over hours due to a sophisticated stimulation protocol. Therefore, we hope that, this especial for elderly CHF patients developed training protocol, may improve their daily activity as well as their quality of life.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 60 years
  • hospitalized due to heart failure
  • left ventricular ejection fraction ≤ 40%
  • NYHA class II to IV
  • willingness to complete the 6-week EMS training programme
  • tolerability of the electrical stimulation
  • provision of informed consent

Exclusion Criteria:

  • severe neuromuscular or oncologic diseases with inability to perform exercise testing and EMS training
  • inotropic intravenous agents used (≤10 days)
  • implanted pacemaker/ICD
  • unstable angina
  • severe uncontrolled arrhythmias
  • patients with severe pulmonary limitation (Tiffeneau ratio <70%, or vital capacity <70% of predicted value)

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
Intervention / Treatment
Active Comparator: Low Intensity EMS
Conventional Stimulation
Device: Electrical muscle devise
evaluate two types of EMS stimulation of legs
Experimental: High Intensity EMS
Russian Stimulation
Device: Electrical muscle devise
evaluate two types of EMS stimulation of legs
Placebo Comparator: Placebo
no Stimulation, supported by phone contact
Device: Electrical muscle devise
evaluate two types of EMS stimulation of legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in 6 minutes walking distance after EMS training
Time Frame: 2 years
The primary outcome of the study is the difference in 6 minutes walking distance (m) between baseline and after 6-weeks EMS training in all groups (high intensity vs low intensity vs control).
2 years

Collaborators and Investigators

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

Sponsor

Kantonsspital Olten

Investigators

  • Principal Investigator: Nisha Arenja, Kantonsspital Olten

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00273

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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