COVID-19, Muscle Atrophy, Muscle Weakness
Conditions
Keywords
Electrical Stimulation, Skin perfusion, Muscle dysfunction
Brief summary
Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.
Detailed description
20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after the first phase of this study is completed. Unlike Phase I (study for prevention), this is a proof of concept randomized control trial (RCT) study for recovery. The patients will be recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The entire cohort will receive daily electrical stimulation in lower extremity (e.g. Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy complications and prolonged hospital stay. Participants will be randomized to intervention (IG) or control group (CG)). EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. In addition to taking the device home to deliver electrical stimulation themselves, the patients will attend a weekly assessment at the McNair Campus for up to 4 weeks. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy.
Interventions
DEVICEElectrical Stimulation
Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks (phase II).
Sponsors
Avazzia, Inc
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Devices may be active or sham.
Intervention model description
Participants will be randomized to intervention (IG) or control group (CG) with ratio of 1:1. The entire cohort will receive daily electrical stimulation (EE) in lower extremity (e.g. Gastrocnemius muscle) for up to 1 hour. The EE device will be functional for IG and non-functional for CG. Phase II will include previously hospitalized patients (n=20) who had recover from severe COVID-19 infection, but present persistent neuromuscular sequelae. This will be performed in an outpatient clinic. The time frame will be 4 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection. * Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.
Exclusion criteria
* Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device. * Active wound infection. * Below the knee amputations. * Based on the clinicians decision whether the patient is eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation | 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). |
| Ankle Strength | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plantar Oxyhemoglobin | 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. |
Countries
United States
Participant flow
Recruitment details
Please note that these results only include Post-Covid-19 Patients (Phase II).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 10 |
| 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). | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Active E-Stim | Electrical Stimulation - Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Continuous | 51.10 years STANDARD_DEVIATION 9.86 | 52.38 years STANDARD_DEVIATION 7.44 | 51.74 years STANDARD_DEVIATION 8.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
Ankle Strength
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).
Time frame: an average of 4 weeks (phase II).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active E-Stim | Ankle Strength | 8.5 Kg | Standard Deviation 4.2 |
| Electrical Stimulation - Sham | Ankle Strength | 7.9 Kg | Standard Deviation 3.7 |
Primary
Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation
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).
Time frame: an average of 4 weeks (Phase II)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active E-Stim | Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation | 363.04 miliVolts | Standard Error 1.56 |
| Electrical Stimulation - Sham | Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation | 359.55 miliVolts | Standard Error 2.04 |
Secondary
Plantar Oxyhemoglobin
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.
Time frame: an average of 4 weeks (phase II)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active E-Stim | Plantar Oxyhemoglobin | .57 Percentage of oxyhemoglobin | Standard Deviation 0.07 |
| Electrical Stimulation - Sham | Plantar Oxyhemoglobin | .54 Percentage of oxyhemoglobin | Standard Deviation 0.06 |