Critical Illness
Conditions
Keywords
ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip
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
Interventions
PROCEDURENEMS
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
PROCEDURESham
Sham sessions of neuromuscular electrical stimulation
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength | up to 2.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | up to 2.5 years | — |
| Functional ability | up to 2.5 years | Functional ability will be assessed with the FIM score |
| Quality of life | up to 2.5 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength in patients with ICU acquired weakness (ICUAW) at ICU discharge | up to 2.5 years | 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 |
Countries
Greece
Outcome results
None listed