NCT01717833

Brief Summary

The purpose of this study is to investigate the role of NEMS as a rehabilitation tool for muscle weakness following critical illness. The investigators hypothesized that NEMS combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_2

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

Study Start

First participant enrolled

November 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

4.1 years

First QC Date

October 21, 2012

Last Update Submit

June 17, 2015

Conditions

Critical Illness

Keywords

ICU acquired weaknessCritical illness polyneuromyopathypost ICU rehabilitationneuromuscular electrical rehabilitationhandgrip

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    up to 2.5 years

Secondary Outcomes (3)

  • Duration of hospital stay

    up to 2.5 years

  • Functional ability

    up to 2.5 years

  • Quality of life

    up to 2.5 years

Other Outcomes (1)

  • Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge

    up to 2.5 years

Study Arms (2)

NEMS group

EXPERIMENTAL
Procedure: NEMS

Sham group

SHAM COMPARATOR
Procedure: Sham

Interventions

NEMSPROCEDURE

NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously

Also known as: Neuromuscular Electrical stimulation
NEMS group
ShamPROCEDURE

Sham sessions of neuromuscular electrical stimulation

Also known as: Sham neuromuscular electrical stimulation
Sham group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under mechanical ventilation for\> 72hours during ICU stay
  • Patients able to perform simple commands (able to be evaluated by MRC scale)

You may not qualify if:

  • age \< 18 \> 85 years
  • pregnancy
  • pre-existing neuromuscular disease (e.g. Gravis)
  • fractures or skin lesions that do not allow the implementation of NEMS
  • presence of pacemaker or defibrillator
  • fractures of spine that so not allow mobilization
  • BMI \> 35 kg/m2
  • terminal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Critical Care Unit, Evaggelismos Hospital, School of Medicine

Athens, Greece

Location

Related Publications (1)

  • Patsaki I, Gerovasili V, Sidiras G, Karatzanos E, Mitsiou G, Papadopoulos E, Christakou A, Routsi C, Kotanidou A, Nanas S. Effect of neuromuscular stimulation and individualized rehabilitation on muscle strength in Intensive Care Unit survivors: A randomized trial. J Crit Care. 2017 Aug;40:76-82. doi: 10.1016/j.jcrc.2017.03.014. Epub 2017 Mar 22.

    PMID: 28364678DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Serafim Nanas, Professor

    University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2012

First Posted

October 31, 2012

Study Start

November 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations

GR(1)