Clinical trial NCT01717833: The Role of NEMS for Post ICU Rehabilitation
Official title: The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Critical Illness
Keywords: ICU acquired weakness
Critical illness polyneuromyopathy
post ICU rehabilitation
neuromuscular electrical rehabilitation
handgrip
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Muscle strength
timeFrame: up to 2.5 years
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: up to 2.5 years
measure: Functional ability
timeFrame: up to 2.5 years
measure: Quality of life
timeFrame: up to 2.5 years
Other outcomes:
measure: Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge
timeFrame: up to 2.5 years
Locations:
city: Athens
country: Greece
facility: First Critical Care Unit, Evaggelismos Hospital, School of Medicine
Study officials:
affiliation: University of Athens
name: Serafim Nanas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.