WeaknessNCT02332187
Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients
A study testing Active electrical stimulation using an All Stim stimulator in people with Weakness, run by Gerald Supinski at 1 site in United States.
Trial summary
Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weakness
- What is being tested?
- Active electrical stimulation using an All Stim stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2013to 5 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients requiring mechanical ventilation for more than 48 hours
- Respiratory failure present
Who cannot join
- The physician caring for the patient determines that the patient is too unstable
- Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine)
- Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure)
- Presence of a cardiac pacemaker or implanted defibrillator
- Use of neuromuscular blocking agents within the 48 hours preceding testing
- History of a preexisting neuromuscular disease
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- Presence of profound and uncorrectable hypokalemia (less than 2.5) or hypophosphatemia (less than 1.0)
- Pregnancy
- If the patient is a prisoner
- If the patient is institutionalized
- If it is thought that the patient will have care withdrawn within 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients.
Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.
Read the detailed description
The objective for this study is to determine if daily exercise using All-Stim 2 stimulation of quadriceps muscles will increase leg strength and improve outcomes (duration of hospitalization, long term mobility, long term disability) for mechanically ventilated MICU patients. The investigators plan to randomize patients accepted into this protocol to administration of either sham exercise (i.e. placement of All-Stim 2 units on the legs for 30 minutes a day without activation of the electrical stimulation program) or active exercise (placement of All-Stim 2 electrodes on both legs and stimulating quadriceps muscles to rhythmically contract for 30 minutes a day). The two groups (sham and active exercise) will be treated for 30 minutes a day for seven days. The effects of exercise on quadriceps strength will be assessed by measuring quadriceps force generation (QuadTw) in response to magnetic stimulation of the femoral nerves. The QuadTw assessment will be made immediately before institution of sham or active exercise and will repeated one day after the conclusion of the seven day training regimen. Chart review and patient follow-up will be used to determine if this treatment regimen also has an impact on clinical outcome measures, i.e. duration of hospitalization.
- Conditions
- Weakness
- Being tested
- Active electrical stimulation using an All Stim stimulator, Sham electrical stimulation using an All Stim stimulator
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active electrical stimulation using an All Stim stimulatorDevice
This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.
Sham electrical stimulation using an All Stim stimulatorDevice
With this intervention the All Stim unit is turned off and no electrical stimulation is provided.
| Study group | Role | What they receive |
|---|---|---|
| Sham electrical stimulation | Sham comparator | The intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days. Receives: Device: Sham electrical stimulation using an All Stim stimulator |
| Active electrical stimulation | Active comparator | The intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days. Receives: Device: Active electrical stimulation using an All Stim stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps Muscle Strength
The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.
Measured: Baseline and One week
Secondary outcomes (1)
Duration of Hospitilization
The investigators will record the total time patients remain hospitilized after entry into the study.
Measured: Baseline to discharge in weeks, up to five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start3 Jan 2013
- Primary completion5 May 2017
- Study completion5 May 2017
Why it stopped: No longer have resources to complete this work.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerald Supinski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerald Supinski, University of Kentucky
- Investigators
- Gerald S Supinski, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332187
- Sponsor's protocol ID
- Protocol 12-0807-F6A
- Status last verified
- Feb 2022
- First submitted
- 30 Dec 2014
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will provide de-identified data to other researchers on request. We cannot, however, under the terms of our IRB approval, provide primary data which contains information that may identify participants. Data will be released once the paper is accepted for publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients.
- ClinicalTrials.gov ID
- NCT02332187
- Acronym / sponsor ID
- Protocol 12-0807-F6A
- Conditions
- Weakness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer have resources to complete this work.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gerald SupinskiUniversity, hospital or other
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients that are on mechanical ventilators in medical intensive care units (MICU) have extremely weak leg muscles. Currently there is no treatment to prevent or reverse this weakness. Treatments with a thigh muscle stimulator, called an All Stim 2, can improve leg muscle strength and help patients regain leg function after knee surgery. The purpose of the present study is to determine if treatments with the All Stim 2 device can also improve leg muscle strength in patients on mechanical ventilation.
Detailed description
The objective for this study is to determine if daily exercise using All-Stim 2 stimulation of quadriceps muscles will increase leg strength and improve outcomes (duration of hospitalization, long term mobility, long term disability) for mechanically ventilated MICU patients. The investigators plan to randomize patients accepted into this protocol to administration of either sham exercise (i.e. placement of All-Stim 2 units on the legs for 30 minutes a day without activation of the electrical stimulation program) or active exercise (placement of All-Stim 2 electrodes on both legs and stimulating quadriceps muscles to rhythmically contract for 30 minutes a day). The two groups (sham and active exercise) will be treated for 30 minutes a day for seven days. The effects of exercise on quadriceps strength will be assessed by measuring quadriceps force generation (QuadTw) in response to magnetic stimulation of the femoral nerves. The QuadTw assessment will be made immediately before institution of sham or active exercise and will repeated one day after the conclusion of the seven day training regimen. Chart review and patient follow-up will be used to determine if this treatment regimen also has an impact on clinical outcome measures, i.e. duration of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham electrical stimulation | Sham comparator | Device: Sham electrical stimulation using an All Stim stimulatorThe intervention will consist of sham electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days. |
| Active electrical stimulation | Active comparator | Device: Active electrical stimulation using an All Stim stimulatorThe intervention will consist of active electrical stimulation using an All Stim stimulator of each quadriceps leg muscle for 30 minutes per day for a total of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients requiring mechanical ventilation for more than 48 hours
- Respiratory failure present
Key exclusion criteria (11 listed)
- The physician caring for the patient determines that the patient is too unstable
- Use of high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine)
- Use of more than 80% FiO2 (fractional concentration of oxygen) or more than 15 cm H2O (water) of PEEP (positive end expiratory pressure)
- Presence of a cardiac pacemaker or implanted defibrillator
- Use of neuromuscular blocking agents within the 48 hours preceding testing
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 |
|---|---|---|
| Active electrical stimulation using an All Stim stimulatorThis is an FDA approved stimulator that is used for strengthening the quadriceps muscle. | Device | Active electrical stimulation |
| Sham electrical stimulation using an All Stim stimulatorWith this intervention the All Stim unit is turned off and no electrical stimulation is provided. | Device | Sham electrical stimulation |
Primary outcome
Change in Quadriceps Muscle Strength
Time frame: Baseline and One week
The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.
1 secondary outcome
Duration of Hospitilization
Time frame: Baseline to discharge in weeks, up to five weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will provide de-identified data to other researchers on request. We cannot, however, under the terms of our IRB approval, provide primary data which contains information that may identify participants. Data will be released once the paper is accepted for publication.
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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.
Gerald S Supinski, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active electrical stimulation using an All Stim stimulator in people with Weakness, run by Gerald Supinski 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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Quadriceps Muscle Strength (time frame: Baseline and One week). 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 2 Mar 2022.