Trial Outcomes & Findings for Electric Muscle Stimulation for Patients With Chronic Respiratory Failure (NCT NCT01930643)
NCT ID: NCT01930643
Last Updated: 2019-07-08
Results Overview
the cumulative ventilator-free days after intervention, in following 28 days.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
28 days
Results posted on
2019-07-08
Participant Flow
Participant milestones
| Measure |
Electric Muscle Stimulation(EMS)
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
|
Control
Patients with routine passive rehabilitation program.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
Baseline characteristics by cohort
| Measure |
Electric Muscle Stimulation(EMS)
n=7 Participants
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
|
Control
n=6 Participants
Patients with routine passive rehabilitation program.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
82 years
n=5 Participants
|
73.5 years
n=7 Participants
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysthe cumulative ventilator-free days after intervention, in following 28 days.
Outcome measures
| Measure |
Electric Muscle Stimulation(EMS)
n=7 Participants
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
|
Control
n=6 Participants
Patients with routine passive rehabilitation program.
|
|---|---|---|
|
Ventilator-free Days
|
6 day
Interval 0.0 to 17.0
|
0 day
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: 7 days after interventionWeekly improvement of both hand grip muscle power in kilogram(Kg)
Outcome measures
Outcome data not reported
Adverse Events
Electric Muscle Stimulation(EMS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place