NCT01825135

Brief Summary

The primary aim of this proposal is to test the effectiveness of NMES in improving functional status and muscle function in patients requirng prolonged mechanical ventilation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

March 28, 2013

Last Update Submit

May 1, 2017

Conditions

Muscle Weakness

Keywords

muscle strengthmuscle functionfunctional status

Outcome Measures

Primary Outcomes (1)

  • modified Functional Independence Measurement (FIM) score

    Functional status as measured by modified Functional Independence Measurement (FIM) score

    Hospital discharge, an expected average stay of 5 weeks

Study Arms (2)

Neuromuscular electrical stimulation

EXPERIMENTAL

Neuromuscular electrical stimulation (NMES) will be applied to the quadriceps muscles for 30 minutes

Device: Neuromuscular electrical stimulation

Sham stimulation

SHAM COMPARATOR

Sham stimulation will be applied to the quadriceps for 30 minutes

Device: sham stimulation

Interventions

Neuromuscular electrical stimulationDEVICE
Also known as: 300PV™ neuromuscular stimulation (NMES)device
Neuromuscular electrical stimulation
sham stimulationDEVICE

sham stimulation will be applied to the quadriceps

Also known as: 300PV™ Neuromuscular Stimulation (NMES) device
Sham stimulation

Eligibility Criteria

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

You may qualify if:

  • duration of mechanical ventilation for 14 days or more
  • sufficiently awake
  • able to speak and comprehend English

You may not qualify if:

  • known primary neuromuscular disease
  • lower extremities paresis or amputee
  • patients with left-ventricular assist device (LVAD)
  • cardiopulmonary instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Amal Jubran, MD

    RML Specialty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator-Staff Physician

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 5, 2013

Study Start

March 1, 2011

Primary Completion

October 1, 2014

Study Completion

August 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)