Critical IllnessPhase 2NCT01717833
The Role of NEMS for Post ICU Rehabilitation
A Phase 2 study testing NEMS in people with Critical Illness, run by University of Athens at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- NEMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2010to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under mechanical ventilation for> 72hours during ICU stay
- Patients able to perform simple commands (able to be evaluated by MRC scale)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Critical Care Unit, Evaggelismos Hospital, School of Medicine
Athens
About this study
Official title: The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
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
Read the 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
- Conditions
- Critical Illness
- Being tested
- NEMS, Sham
- Keywords
- ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMSProcedure or surgery
Also called Neuromuscular Electrical stimulation
NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
ShamProcedure or surgery
Also called Sham neuromuscular electrical stimulation
Sham sessions of neuromuscular electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| NEMS group | Experimental | Not described Receives: Procedure: NEMS |
| Sham group | Sham comparator | Not described Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Measured: up to 2.5 years
Secondary outcomes (3)
Duration of hospital stay
Measured: up to 2.5 years
Functional ability
Functional ability will be assessed with the FIM score
Measured: up to 2.5 years
Quality of life
Measured: up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2010
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafim Nanas, University of Athens
- Investigators
- Serafim Nanas, Professor, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717833
- Sponsor's protocol ID
- SN01032010
- Status last verified
- Jun 2015
- First submitted
- 21 Oct 2012
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28364678
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuromuscular Electrical Stimulation as a Tool for Post ICU Rehabilitation
- ClinicalTrials.gov ID
- NCT01717833
- Acronym / sponsor ID
- SN01032010
- Conditions
- Critical Illness
- Keywords
- ICU acquired weakness, Critical illness polyneuromyopathy, post ICU rehabilitation, neuromuscular electrical rehabilitation, handgrip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEMS group | Experimental | Procedure: NEMS |
| Sham group | Sham comparator | Procedure: Sham |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients under mechanical ventilation for> 72hours during ICU stay
- Patients able to perform simple commands (able to be evaluated by MRC scale)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMSAlso: Neuromuscular Electrical stimulationNEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously | Procedure or surgery | NEMS group |
| ShamAlso: Sham neuromuscular electrical stimulationSham sessions of neuromuscular electrical stimulation | Procedure or surgery | Sham group |
Primary outcome
Muscle strength
Time frame: up to 2.5 years
3 secondary outcomes
Duration of hospital stay
Time frame: up to 2.5 years
Functional ability
Time frame: up to 2.5 years
Quality of life
Time frame: up to 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- Derived from this study: PubMed 28364678Patsaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serafim Nanas, Professor principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NEMS in people with Critical Illness, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: up to 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.