The Role of NEMS for Post ICU Rehabilitation | NCT01717833

Studies
The Role of NEMS for Post ICU Rehabilitation

NCT01717833

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

Jun 18, 2015Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Critical Illness

Interventions

NEMS
Sham

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Estimated

First Submitted Date

Oct 21, 2012

First Submission Date that Met QC Criteria

Oct 28, 2012

First Posted Date

Oct 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2015

Last Update Posted Date

Jun 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Serafim Nanas, Professor, University of AthensPrincipal Investigator

Lead Sponsor

University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term.

Neuromuscular electrical stimulation (NEMS) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. NEMS has also been used as a preventive tool for intensive care unit (ICU) acquired weakness (ICUAW). Its role as a tool for post ICU rehabilitation has not been evaluated so far.

A randomized intervention study was designed to assess the efficacy of NEMS, as a rehabilitative tool for critical illness survivors. The first day that patients are discharged from the ICU after stratified randomization are assigned to the NEMS group or to the control group. In the NEMS group, NEMS will be applied to both lower extremities of the NEMS -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. NEMS sessions will continue until patient discharge from hospital. In the control group, sham NEMS will be applied along with standard care when it comes to physiotherapy. At hospital discharge patients of both groups of will receive a rehabilitation booklet. Patients on the NEMS group that have significant muscle weakness will have NEMS sessions at home for a period of 2 months. Patients are evaluated at 3 and 6 months after hospital discharge

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NEMS group	Experimental		Procedure: NEMS
Sham group	Sham Comparator		Procedure: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEMS	Procedure	NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously	NEMS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle strength		up to 2.5 years

Secondary Outcomes

Measure	Description	Time Frame
Duration of hospital stay		up to 2.5 years
Functional ability	Functional ability will be assessed with the FIM score	up to 2.5 years

Other Outcomes

Measure	Description	Time Frame
Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge	In the subgroup of patients diagnosed with ICUAW improvement in muscle strength will be assessed in patients of the NEMS group as compared to the sham-NEMS group	up to 2.5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serafim Nanas, Professor	University of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Critical Care Unit, Evaggelismos Hospital, School of Medicine		Athens			Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28364678	Derived	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms