PolyneuropathiesNCT03765489
Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock
A study testing electrical muscle stimulation and conventional physical therapy in people with Polyneuropathies and Septic Shock, run by University of Chile.
Trial summary
The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyneuropathies, Septic Shock, Muscle Weakness
- What is being tested?
- electrical muscle stimulation and conventional physical therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2016to 21 Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
- Diagnosis of severe sepsis or septic shock
- More than 48 hours in VMI
- With sedation and / or neuromuscular blockade
- Autovalent prior to admission to the ICU
Who cannot join
- Subjects from other hospitals / clinics or units of the hospital
- Multiple trauma
- Previous neuromuscular pathology
- Pacemaker users
- Pregnant women
- BMI> 35
- Epilepsy
- Those who have refused to sign informed consent
About this study
Official title: Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study
The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.
Read the detailed description
Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.
- Conditions
- Polyneuropathies, Septic Shock, Muscle Weakness
- Being tested
- electrical muscle stimulation, conventional physical therapy
- Keywords
- polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit
- Medical subject headings
- Polyneuropathies, Shock, Septic, Muscle Weakness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical muscle stimulationDevice
electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
conventional physical therapyProcedure or surgery
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
| Study group | Role | What they receive |
|---|---|---|
| electrical muscle stimulation | Experimental | conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction Receives: Device: electrical muscle stimulation; Procedure: conventional physical therapy |
| conventional physical therapy | Active comparator | conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al Receives: Procedure: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care unit acquired weakness
Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness
Measured: at awakening of the subject, an average of 8 days
Secondary outcomes (8)
muscle strength
Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength).
Measured: at awakening of the subject, an average of 8 days
muscle mass
ultrasonography
Measured: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
maximum inspiratory pressure
maximum inspiratory pressure
Measured: at awakening of the subject, an average of 8 days
days of mechanical ventilation
number of days wirh mechanical ventilation
Measured: an average of 11 days
Number of Participants with weaning failure
Number of Participants who presented reintubation
Measured: 48 hours post extubation day
days of ICU stay
number of days in ICU
Measured: at ICU discharge, an average of 18 days
mortality at 28 days
mortality
Measured: at 28 days post ICU admission
gait ability at hospital discharge
presence or not of gait ability
Measured: at hospital discharge, an averange of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start18 Nov 2016
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathiesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, daniel arellano sepulveda, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765489
- Sponsor's protocol ID
- OAIC 847/16
- Status last verified
- Dec 2018
- First submitted
- 12 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT03765489
- Acronym / sponsor ID
- OAIC 847/16
- Conditions
- Polyneuropathies, Septic Shock, Muscle Weakness
- Keywords
- polyneuropathies, muscle weakness, sepsis, septic shock, electrical stimulation, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 5 Dec 2018 (actual)
- 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 aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.
Detailed description
Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical muscle stimulation | Experimental | Device: electrical muscle stimulation, Procedure: conventional physical therapyconventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction |
| conventional physical therapy | Active comparator | Procedure: conventional physical therapyconventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
- Diagnosis of severe sepsis or septic shock
- More than 48 hours in VMI
- With sedation and / or neuromuscular blockade
- Autovalent prior to admission to the ICU
Key exclusion criteria (8 listed)
- Subjects from other hospitals / clinics or units of the hospital
- Multiple trauma
- Previous neuromuscular pathology
- Pacemaker users
- Pregnant women
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 |
|---|---|---|
| electrical muscle stimulationelectrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction | Device | electrical muscle stimulation |
| conventional physical therapyconventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al | Procedure or surgery | conventional physical therapy, electrical muscle stimulation |
Primary outcome
intensive care unit acquired weakness
Time frame: at awakening of the subject, an average of 8 days
Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness
8 secondary outcomes
muscle strength
Time frame: at awakening of the subject, an average of 8 days
muscle mass
Time frame: at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days
maximum inspiratory pressure
Time frame: at awakening of the subject, an average of 8 days
days of mechanical ventilation
Time frame: an average of 11 days
Number of Participants with weaning failure
Time frame: 48 hours post extubation day
days of ICU stay
Time frame: at ICU discharge, an average of 18 days
mortality at 28 days
Time frame: at 28 days post ICU admission
gait ability at hospital discharge
Time frame: at hospital discharge, an averange of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electrical muscle stimulation and conventional physical therapy in people with Polyneuropathies and Septic Shock, run by University of Chile.
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 5 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: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intensive care unit acquired weakness (time frame: at awakening of the subject, an average of 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2018.