Muscle DisuseNCT01521637
The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
A study testing Neuromuscular Electrical Stimulation of m. quadriceps femoris in people with Muscle Disuse and Neuromuscular Electrical Stimulation (NMES), run by Hasselt University at 1 site in Belgium.
Trial summary
Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Muscle Disuse, Neuromuscular Electrical Stimulation (NMES), Critical Illness
- What is being tested?
- Neuromuscular Electrical Stimulation of m. quadriceps femoris
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Apr 2015
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Age between 18 and 80 years
- Expected sedated time of >24h
Who cannot join
- Spinal Cord Injury
- Arterial operaties on the legs
- Local wounds that prohibit NMES
- Chronic use of corticosteroids
- Intake of certain antithrombotic drugs
- Presence of implantable cardioverter defibrillator and/or pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients
Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.
- Being tested
- Neuromuscular Electrical Stimulation of m. quadriceps femoris, Sham-treatment: no NMES
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical Stimulation of m. quadriceps femorisProcedure or surgery
Also called Electrical stimulation
Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator
Sham-treatment: no NMESProcedure or surgery
Also called No electrical stimulation; the leg will be sham-treated
Sham comparator
| Study group | Role | What they receive |
|---|---|---|
| NMES | Experimental | The 'NMES' arm will be treated with NMES. Receives: Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femoris |
| No NMES | Sham comparator | The 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used. Receives: Procedure: Sham-treatment: no NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle fiber cross sectional area (CSA)
Muscle fiber cross sectional area (in um2) for type I and II fibers will be analyzed by using immunohistochemistry; the change of muscle fiber CSA over time will be measured
Measured: 3 hours before and 12 hours after 10 days of twice-daily NMES
Secondary outcomes (1)
Change in upper leg circumference
Upper leg circumgerence will be measured; the change of upper leg circumference over time will be measured
Measured: 3 hours before and 12 hours after 10 days of twice-daily NMES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DisuseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521637
- Sponsor's protocol ID
- NMES2012
- Status last verified
- Aug 2015
- First submitted
- 18 Jan 2012
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients
- ClinicalTrials.gov ID
- NCT01521637
- Acronym / sponsor ID
- NMES2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- First posted
- 31 Jan 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.
Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES | Experimental | Procedure: Neuromuscular Electrical Stimulation of m. quadriceps femorisThe 'NMES' arm will be treated with NMES. |
| No NMES | Sham comparator | Procedure: Sham-treatment: no NMESThe 'No NMES' arm of the experiment will be sham-treated with NMES. The device will be installed, but not used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male
- Age between 18 and 80 years
- Expected sedated time of >24h
Key exclusion criteria (6 listed)
- Spinal Cord Injury
- Arterial operaties on the legs
- Local wounds that prohibit NMES
- Chronic use of corticosteroids
- Intake of certain antithrombotic drugs
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 |
|---|---|---|
| Neuromuscular Electrical Stimulation of m. quadriceps femorisAlso: Electrical stimulationNeuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator | Procedure or surgery | NMES |
| Sham-treatment: no NMESAlso: No electrical stimulation; the leg will be sham-treatedSham comparator | Procedure or surgery | No NMES |
Primary outcome
Change in muscle fiber cross sectional area (CSA)
Time frame: 3 hours before and 12 hours after 10 days of twice-daily NMES
Muscle fiber cross sectional area (in um2) for type I and II fibers will be analyzed by using immunohistochemistry; the change of muscle fiber CSA over time will be measured
1 secondary outcome
Change in upper leg circumference
Time frame: 3 hours before and 12 hours after 10 days of twice-daily NMES
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 19 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation of m. quadriceps femoris in people with Muscle Disuse and Neuromuscular Electrical Stimulation (NMES), run by Hasselt University at 1 site in Belgium.
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 3 inclusion and 6 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 19 Aug 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 Belgium. 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.
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?
Change in muscle fiber cross sectional area (CSA) (time frame: 3 hours before and 12 hours after 10 days of twice-daily NMES). 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 19 Aug 2015.