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Completed

NCT Number: NCT01548508

Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation

The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universty Hospital Toulouse Cardiology

Toulouse, 31059, France

About this study

Advanced Chronic Heart Failure (ACHF) is a severe and frequent disease inducing a strong limitation of exercise capacity and a poor quality of life. Hospitalisation for cardiac decompensation is frequent and could alter their incapacities because of muscular deconditionning. Tradionnal aerobic rehabilitation exercises fighting against this deconditionning are not relevant in these patients because of dyspnea.

In litterature, Functionnal Electrostimulation (FES) has been tested in stable Chronic Heart Failure (NYHA I to III), far from decompensation. Several authors showed the same improvements than those obtained with conventionnal rehabilitation on aerobic capacities (peak VO2, 6 minutes walking test) and quality of life.

The originality of this study is to test FES soon after acute heart decompensation in ACHF patients. This type of rehabilitation could represent in the future an alternative to conventionnal rehabilitation until the patients could be able to do aerobic exercise.

60 patients will be randomised between two groups, the firsth receiving FES (treatment group), the second receiving skin electrostimulation in the same place without muscular contraction (Sham group). Patient and evaluator do not know what type of stimulation they have. These treatments spread over six weeks, five days per seven. They are began in rehabilitation unit then continued at home.

The principal criteria of judgement of FES efficacy is peak VO2 after the protocol. Secondary criteria are distance to the six minutes walking test, muscular strengh of quadriceps, the muscle mass measured by Dual energy X-ray absorptiometry (DEXA), inflamatory dosage (TNF alpha, IL-1, IL-6, CRP), rest value of Muscle sympathetic nerve activity, score to Minnesota questionnaire and fuctionnal independance.

The attempted results are an significative improvement of aerobic capacity(peak VO2 and six minutes walking test) and the others secondary criteria in FES group compared with Sham group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced Chronic Heart Failure (NYHA III to IV)
  • Cardiac Ejection Fraction < 40 %
  • peak VO2 < 16 ml/kg/min,
  • optimal drug treatment of CHF,
  • hospitalised for acute decompensation but not in intensive care

Exclusion criteria

  • Chronic Obstructive Pulmonary Disease with FEV < 50%,
  • History of stroke with walking disability, dementia.

Treatment and study plan

Functionnal ElectroStimulation (FES)

Other

Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks

SHAM

Other

SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks

Primary outcomes

  1. VO2 peak

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

Secondary outcomes

  1. Muscle nerve sympathetic activity (MSNA)

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  2. Six minutes walking test

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  3. DEXA

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  4. maximal quadriceps strengh

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  5. interleukin 1

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  6. interleukin 6

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  7. TNF alpha

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  8. CRP

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  9. BNP

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  10. score of minessota test

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

  11. score of Functional independency measure

    Time frame: change between baseline and 60 days after the Functional Electromyo Stimulation

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Foundation for the Future, Paris, France

Registry information

Acronym: EMSICA

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2012
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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