Weakness
Conditions
Brief 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. 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.
Interventions
DEVICEActive electrical stimulation using an All Stim stimulator
This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.
DEVICESham electrical stimulation using an All Stim stimulator
With this intervention the All Stim unit is turned off and no electrical stimulation is provided.
Sponsors
Gerald Supinski
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quadriceps Muscle Strength | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospitilization | Baseline to discharge in weeks, up to five weeks | The investigators will record the total time patients remain hospitilized after entry into the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Electrical Stimulation 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.
Sham electrical stimulation using an All Stim stimulator: With this intervention the All Stim unit is turned off and no electrical stimulation is provided. | 5 |
| Active Electrical Stimulation 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.
Active electrical stimulation using an All Stim stimulator: This is an FDA approved stimulator that is used for strengthening the quadriceps muscle. | 10 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Active Electrical Stimulation | Total | Sham Electrical Stimulation |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 15.5 | 50.2 years STANDARD_DEVIATION 16.1 | 58.4 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 15 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 15 Participants | 5 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 10 |
| other Total, other adverse events | 0 / 5 | 0 / 10 |
| serious Total, serious adverse events | 0 / 5 | 1 / 10 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Electrical Stimulation | Change in Quadriceps Muscle Strength | Left quadricep | -6.1 Newtons | Standard Deviation 7.4 |
| Sham Electrical Stimulation | Change in Quadriceps Muscle Strength | Right quadricep | -5.0 Newtons | Standard Deviation 5.8 |
| Active Electrical Stimulation | Change in Quadriceps Muscle Strength | Left quadricep | 3.4 Newtons | Standard Deviation 3.6 |
| Active Electrical Stimulation | Change in Quadriceps Muscle Strength | Right quadricep | 2.6 Newtons | Standard Deviation 2.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Electrical Stimulation | Duration of Hospitilization | 4.6 weeks | Standard Deviation 0 |
| Active Electrical Stimulation | Duration of Hospitilization | 3.0 weeks | Standard Deviation 0.7 |