NCT03793647

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

October 5, 2018

Last Update Submit

April 11, 2021

Conditions

Congestive Heart FailureElectric Muscle StimulationSevere DeconditionElderly PersonExercise CapacityActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Difference in 6 minutes walking distance after EMS training

    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

Study Arms (3)

Low Intensity EMS

ACTIVE COMPARATOR

Conventional Stimulation

Device: Electrical muscle devise

High Intensity EMS

EXPERIMENTAL

Russian Stimulation

Device: Electrical muscle devise

Placebo

PLACEBO COMPARATOR

no Stimulation, supported by phone contact

Device: Electrical muscle devise

Interventions

Electrical muscle deviseDEVICE

evaluate two types of EMS stimulation of legs

High Intensity EMSLow Intensity EMSPlacebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Olten

Olten, 4600, Switzerland

RECRUITING

Related Publications (10)

  • Deley G, Kervio G, Verges B, Hannequin A, Petitdant MF, Salmi-Belmihoub S, Grassi B, Casillas JM. Comparison of low-frequency electrical myostimulation and conventional aerobic exercise training in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2005 Jun;12(3):226-33. doi: 10.1097/01.hjr.0000166455.23346.a5.

    PMID: 15942420BACKGROUND

  • Dobsak P, Novakova M, Siegelova J, Fiser B, Vitovec J, Nagasaka M, Kohzuki M, Yambe T, Nitta S, Eicher JC, Wolf JE, Imachi K. Low-frequency electrical stimulation increases muscle strength and improves blood supply in patients with chronic heart failure. Circ J. 2006 Jan;70(1):75-82. doi: 10.1253/circj.70.75.

    PMID: 16377928BACKGROUND

  • Harris S, LeMaitre JP, Mackenzie G, Fox KA, Denvir MA. A randomised study of home-based electrical stimulation of the legs and conventional bicycle exercise training for patients with chronic heart failure. Eur Heart J. 2003 May;24(9):871-8. doi: 10.1016/s0195-668x(02)00822-9.

    PMID: 12727155BACKGROUND

  • Karavidas A, Arapi SM, Pyrgakis V, Adamopoulos S. Functional electrical stimulation of lower limbs in patients with chronic heart failure. Heart Fail Rev. 2010 Nov;15(6):563-79. doi: 10.1007/s10741-010-9171-9.

    PMID: 20490656BACKGROUND

  • Karavidas A, Driva M, Parissis JT, Farmakis D, Mantzaraki V, Varounis C, Paraskevaidis I, Ikonomidis I, Pirgakis V, Anastasiou-Nana M, Filippatos G. Functional electrical stimulation of peripheral muscles improves endothelial function and clinical and emotional status in heart failure patients with preserved left ventricular ejection fraction. Am Heart J. 2013 Oct;166(4):760-7. doi: 10.1016/j.ahj.2013.06.021. Epub 2013 Aug 30.

    PMID: 24093858BACKGROUND

  • Nuhr M, Crevenna R, Gohlsch B, Bittner C, Pleiner J, Wiesinger G, Fialka-Moser V, Quittan M, Pette D. Functional and biochemical properties of chronically stimulated human skeletal muscle. Eur J Appl Physiol. 2003 Apr;89(2):202-8. doi: 10.1007/s00421-003-0792-8. Epub 2003 Feb 28.

    PMID: 12665986BACKGROUND

  • Quittan M, Sochor A, Wiesinger GF, Kollmitzer J, Sturm B, Pacher R, Mayr W. Strength improvement of knee extensor muscles in patients with chronic heart failure by neuromuscular electrical stimulation. Artif Organs. 1999 May;23(5):432-5. doi: 10.1046/j.1525-1594.1999.06372.x.

    PMID: 10378936BACKGROUND

  • Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.

    PMID: 20560163BACKGROUND

  • Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Epub 2012 Jan 10.

    PMID: 22236510BACKGROUND

  • Vaquero AF, Chicharro JL, Gil L, Ruiz MP, Sanchez V, Lucia A, Urrea S, Gomez MA. Effects of muscle electrical stimulation on peak VO2 in cardiac transplant patients. Int J Sports Med. 1998 Jul;19(5):317-22. doi: 10.1055/s-2007-971924.

    PMID: 9721054BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nisha Arenja

    Kantonsspital Olten

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nisha Arenja, Dr

CONTACT

0041 62 311 49 45nisha.arenja@spital.so.ch

Hugo Saner, Prof.

CONTACT

Hugo.Saner@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 5, 2018

First Posted

January 4, 2019

Study Start

April 1, 2019

Primary Completion

August 1, 2021

Study Completion

December 30, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)