Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients.

Conditions
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Weakness

Intervention / Treatment
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* Device: Active electrical stimulation using an All Stim stimulator
* Device: Sham electrical stimulation using an All Stim stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients requiring mechanical ventilation for more than 48 hours Respiratory failure present Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham electrical stimulation<br>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<br>* With this intervention the All Stim unit is turned off and no electrical stimulation is provided.<br>|
| Active Comparator: Active electrical stimulation<br>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<br>* This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hospitilization | The investigators will record the total time patients remain hospitilized after entry into the study. | Baseline to discharge in weeks, up to five weeks |