Trial Outcomes & Findings for Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients (NCT NCT02332187)
NCT ID: NCT02332187
Last Updated: 2022-03-02
Results Overview
The investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline and One week
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Effect of All-Stim 2 Quadriceps Treatments on Limb Muscle Strength In Mechanically Ventilated Patients
Baseline characteristics by cohort
| Measure |
Sham Electrical Stimulation
n=5 Participants
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.
|
Active Electrical Stimulation
n=10 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and One weekThe investigators will measure quadriceps leg strength before and after one week of either sham or active electrical stimulation of the quadriceps muscle.
Outcome measures
| Measure |
Sham Electrical Stimulation
n=3 Participants
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.
|
Active Electrical Stimulation
n=7 Participants
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.
|
|---|---|---|
|
Change in Quadriceps Muscle Strength
Right quadricep
|
-5.0 Newtons
Standard Deviation 5.8
|
2.6 Newtons
Standard Deviation 2.2
|
|
Change in Quadriceps Muscle Strength
Left quadricep
|
-6.1 Newtons
Standard Deviation 7.4
|
3.4 Newtons
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline to discharge in weeks, up to five weeksThe investigators will record the total time patients remain hospitilized after entry into the study.
Outcome measures
| Measure |
Sham Electrical Stimulation
n=3 Participants
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.
|
Active Electrical Stimulation
n=7 Participants
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.
|
|---|---|---|
|
Duration of Hospitilization
|
4.6 weeks
Standard Deviation 0
|
3.0 weeks
Standard Deviation 0.7
|
Adverse Events
Sham Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Electrical Stimulation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sham Electrical Stimulation
n=5 participants at risk
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.
|
Active Electrical Stimulation
n=10 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/5 • Baseline to end of hospitalizations for all participants, up to five weeks.
|
10.0%
1/10 • Number of events 1 • Baseline to end of hospitalizations for all participants, up to five weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place