Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | December 2014 |
| End Date: | September 2019 |
| Contact: | Gerald S Supinski, MD |
| Email: | gsupi2@email.uky.edu |
| Phone: | 859-494-3480 |
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.
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.
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.
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
We found this trial at
1
site
Lexington, Kentucky 40536
Principal Investigator: Gerald Supinski, MD
Phone: 859-494-3480
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