An interventional study of Active electrical stimulation using an All Stim stimulator and Sham electrical stimulation using an All Stim stimulator in Weakness, sponsored by Gerald Supinski. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Gerald Supinski · Not applicable, Interventional, and Treatment
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.
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.
Gerald Supinski is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Sham electrical stimulation using an All Stim stimulator
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.
Device: Active electrical stimulation using an All Stim stimulator
This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.
With this intervention the All Stim unit is turned off and no electrical stimulation is provided.
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.
Time frame: Baseline and One week
Duration of Hospitilization
The investigators will record the total time patients remain hospitilized after entry into the study.
Time frame: Baseline to discharge in weeks, up to five weeks
| Milestone | Sham Electrical Stimulation | Active Electrical Stimulation |
|---|---|---|
| Started | 5 | 10 |
| Completed | 3 | 7 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Adverse event | 0 | 1 |
The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.
| Newtons | Sham Electrical Stimulation | Active Electrical Stimulation |
|---|---|---|
| Right quadricep | -5.0 ± 5.8 | 2.6 ± 2.2 |
| Left quadricep | -6.1 ± 7.4 | 3.4 ± 3.6 |
The investigators will record the total time patients remain hospitilized after entry into the study.
| weeks | Sham Electrical Stimulation | Active Electrical Stimulation |
|---|---|---|
| Duration of Hospitilization | 4.6 ± 0 | 3.0 ± 0.7 |
Collected over Baseline to end of hospitalizations for all participants, up to five weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Electrical Stimulation | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Active Electrical Stimulation | 1/10 (10%) | 1/10 (10%) | 0/10 (0%) |
| Event | Sham Electrical Stimulation | Active Electrical Stimulation |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 0/5 | 1/10 |
| Age, Continuous(years) | Sham Electrical Stimulation | Active Electrical Stimulation | Total |
|---|---|---|---|
| Mean | 58.4 ± 15.5 | 46.1 ± 15.5 | 50.2 ± 16.1 |
| Sex: Female, Male(Participants) | Sham Electrical Stimulation | Active Electrical Stimulation | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 0 | 4 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Sham Electrical Stimulation | Active Electrical Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 10 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sham Electrical Stimulation | Active Electrical Stimulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 10 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gerald Supinski