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Trial Outcomes & Findings for Electrical Stimulation for Critically Ill Post-Covid-19 Patients (NCT NCT05198466)

NCT ID: NCT05198466

Last Updated: 2023-03-07

Results Overview

Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

an average of 4 weeks (Phase II)

Results posted on

2023-03-07

Participant Flow

Please note that these results only include Post-Covid-19 Patients (Phase II).

Participant milestones

Participant milestones
Measure
Active E-Stim
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Overall Study
STARTED
10
9
Overall Study
COMPLETED
10
8
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Stimulation for Critically Ill Post-Covid-19 Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active E-Stim
n=10 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Total
n=18 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
10 Participants
n=5 Participants
8 Participants
n=7 Participants
18 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
51.10 years
STANDARD_DEVIATION 9.86 • n=5 Participants
52.38 years
STANDARD_DEVIATION 7.44 • n=7 Participants
51.74 years
STANDARD_DEVIATION 8.65 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 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

PRIMARY outcome

Timeframe: an average of 4 weeks (Phase II)

Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

Outcome measures

Outcome measures
Measure
Active E-Stim
n=10 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
363.04 miliVolts
Standard Error 1.56
359.55 miliVolts
Standard Error 2.04

PRIMARY outcome

Timeframe: an average of 4 weeks (phase II).

Ankle strength will be measured in response to the average of three 5-second dorsiflexion maximum voluntary isometric contractions per 30 seconds of relaxation in-between using a dynamometer (RoMech Digital Hanging Scale).

Outcome measures

Outcome measures
Measure
Active E-Stim
n=10 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Ankle Strength
8.5 Kg
Standard Deviation 4.2
7.9 Kg
Standard Deviation 3.7

SECONDARY outcome

Timeframe: an average of 4 weeks (phase II)

Percentage of oxyhemoglobin (OxyHb) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time OxyHb level in superficial tissue. The metatarsus area including the five toes will be traced. Data reported includes plantar oxyhemoglobin after 10 minutes of stopping 1 hour of electrical stimulation therapy.

Outcome measures

Outcome measures
Measure
Active E-Stim
n=10 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation: Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Electrical Stimulation - Sham
n=8 Participants
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II). Electrical Stimulation - Sham: Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Plantar Oxyhemoglobin
.57 Percentage of oxyhemoglobin
Standard Deviation .07
.54 Percentage of oxyhemoglobin
Standard Deviation .06

Adverse Events

Active E-Stim

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Electrical Stimulation - Sham

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

Bijan Najafi

Baylor College of Medicine

Phone: 7137987536

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place