Muscle WeaknessNCT02847988
Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
A study testing Neuromuscular electrical Stimulation (NMES) in people with Muscle Weakness, run by RML Specialty Hospital at 1 site in United States.
Trial summary
The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Neuromuscular electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of mechanical ventilation >14 days
- Sufficiently awake
- Able to speak and comprehend English
- Willingness to participate
Who cannot join
- Cardiopulmonary Instability
- Acute-onset neuromuscular disease
- Lower-extremity amputee or paresis
- Open wound at electrode application points
- Pitting edema grade ≥3
- Presence of pacemaker, implanted defibrillator, or ventricular-assist device
- inability to transfer from sitting to standing before critical illness
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
RML Specialty Hospital
Hinsdale, Illinois, 60521
Lisa Duffner, 630-286-4149, lmikolajewski@rmlspecialtyhospital.org
Maryann Oliver, 630-286-4127
About this study
The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.
- Conditions
- Muscle Weakness
- Being tested
- Neuromuscular electrical Stimulation (NMES), Sham Stimulation
- Keywords
- muscle strength, muscle function, functional status
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical Stimulation (NMES)Device
Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction
Sham StimulationDevice
Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).
| Study group | Role | What they receive |
|---|---|---|
| Neuro-muscular electrical stimulation | Active comparator | Intervention:Neuromuscular electrical stimulation (NMES)
NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES Receives: Device: Neuromuscular electrical Stimulation (NMES) |
| Sham stimulation | Sham comparator | Intervention: sham stimulation
Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach independence in performing functional activity
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
Measured: Hospital discharge, an expected average stay of 5 weeks
Secondary outcomes (1)
The percentage of patients who can perform functional activities independently
Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH
Measured: Hospital discharge, an expected average stay of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RML Specialty Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Amal Jubran, RML Specialty Hospital
- Investigators
- Amal Jubran, MD, Principal investigator, RML Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847988
- Sponsor's protocol ID
- AXJ014
- Other IDs
- R01NR016055
- Status last verified
- Mar 2021
- First submitted
- 25 Jul 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02847988
- Acronym / sponsor ID
- AXJ014
- Conditions
- Muscle Weakness
- Keywords
- muscle strength, muscle function, functional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RML Specialty HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 28 Jul 2016 (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 primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro-muscular electrical stimulation | Active comparator | Device: Neuromuscular electrical Stimulation (NMES)Intervention:Neuromuscular electrical stimulation (NMES) NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES |
| Sham stimulation | Sham comparator | Device: Sham StimulationIntervention: sham stimulation Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Duration of mechanical ventilation >14 days
- Sufficiently awake
- Able to speak and comprehend English
- Willingness to participate
Key exclusion criteria (7 listed)
- Cardiopulmonary Instability
- Acute-onset neuromuscular disease
- Lower-extremity amputee or paresis
- Open wound at electrode application points
- Pitting edema grade ≥3
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 (NMES)Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction | Device | Neuro-muscular electrical stimulation |
| Sham StimulationSham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). | Device | Sham stimulation |
Primary outcome
Time to reach independence in performing functional activity
Time frame: Hospital discharge, an expected average stay of 5 weeks
Functional activity as measured by functional activity measurement for the ICU (FSS-ICU)
1 secondary outcome
The percentage of patients who can perform functional activities independently
Time frame: Hospital discharge, an expected average stay of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Amal Jubran, MD principal investigator
RML Specialty Hospital
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 (NMES) in people with Muscle Weakness, run by RML Specialty Hospital at 1 site in United States.
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 7 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 11 Mar 2021. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa A Duffner, B.A.,B.S. (630-286-4149, lmikolajewski@rmlspecialtyhospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach independence in performing functional activity (time frame: Hospital discharge, an expected average stay of 5 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 11 Mar 2021.