Critical IllnessPhase 1/2NCT01637467
Effect of Electrical Muscle Stimulation in Critically Ill Patients
A Phase 1/2 study testing Electrical muscle stimulation (EMS) in people with Critical Illness, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Electrical muscle stimulation (EMS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Oct 2015
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the medical-surgical ICU or cardiovascular ICU
- walking independently prior to admission
- mechanically ventilated for more than 7 days (i.e. prolonged ventilation)
- receiving enteral or parenteral nutrition.
Who cannot join
- history of neurological or psychiatric disease
- primary muscle disease (e.g. muscular dystrophy, polymyositis)
- catastrophic neurological event
- receiving palliative care
- contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)
- inadequate access to electrode sites due to medical devices
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- lower extremity edema affecting the thighs or buttocks
- BMI > 35 kg/m2
- allergies to adhesives or latex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial
Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.
- Conditions
- Critical Illness
- Being tested
- Electrical muscle stimulation (EMS), Sham EMS
- Keywords
- critical illness, myopathy, electrical muscle stimulation
- Medical subject headings
- Critical Illness, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical muscle stimulation (EMS)Other
EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
Sham EMSOther
Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| EMS intervention | Experimental | The experimental group will received EMS at a therapeutic level. Receives: Other: Electrical muscle stimulation (EMS) |
| Sham | Sham comparator | The sham group will receive EMS at a sub-therapeutic level. Receives: Other: Sham EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of EMS treatment
the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted
Measured: 4 weeks
Secondary outcomes (2)
muscle strength
muscle strength using manual muscle testing
Measured: baseline, 2 weeks and 4 weeks
muscle thickness
thickness of the quadriceps muscle will be assessed using muscle ultrasound
Measured: baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Lung Association
- Responsible party
- Principal investigator, Sunita Mathur, University Health Network, Toronto
- Investigators
- Vincent Lo, BSc(PT), Principal investigator, University Health Network, TorontoSunita Mathur, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637467
- Sponsor's protocol ID
- 11-0639A
- Status last verified
- May 2015
- First submitted
- 6 Jul 2012
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01637467
- Acronym / sponsor ID
- 11-0639A
- Conditions
- Critical Illness
- Keywords
- critical illness, myopathy, electrical muscle stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Lung Association
- Study start
- Jul 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jul 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.
Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS intervention | Experimental | Other: Electrical muscle stimulation (EMS)The experimental group will received EMS at a therapeutic level. |
| Sham | Sham comparator | Other: Sham EMSThe sham group will receive EMS at a sub-therapeutic level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to the medical-surgical ICU or cardiovascular ICU
- walking independently prior to admission
- mechanically ventilated for more than 7 days (i.e. prolonged ventilation)
- receiving enteral or parenteral nutrition.
Key exclusion criteria (9 listed)
- history of neurological or psychiatric disease
- primary muscle disease (e.g. muscular dystrophy, polymyositis)
- catastrophic neurological event
- receiving palliative care
- contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)
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 stimulation (EMS)EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks. | Other | EMS intervention |
| Sham EMSSham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks. | Other | Sham |
Primary outcome
feasibility of EMS treatment
Time frame: 4 weeks
the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted
2 secondary outcomes
muscle strength
Time frame: baseline, 2 weeks and 4 weeks
muscle thickness
Time frame: baseline, 2 weeks, 4 weeks
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 9 Feb 2016.
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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.
Vincent Lo, BSc(PT) principal investigator
University Health Network, Toronto
Sunita Mathur, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Electrical muscle stimulation (EMS) in people with Critical Illness, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 9 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 9 Feb 2016. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
feasibility of EMS treatment (time frame: 4 weeks). 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 9 Feb 2016.