COVID-19 PneumoniaNCT04382729
Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia
A study testing Neuromuscular Electrical Stimulation and Physical Therapy Exercise in people with COVID-19 Pneumonia, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Neuromuscular Electrical Stimulation and Physical Therapy Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years
- respiratory (PaO2/FiO2 ratio > 180 mmHg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents
Who cannot join
- pregnancy
- known or suspected malignancy in the lower limbs
- body mass index equal or greater than 35 kg/m2
- conditions preventing NMES treatment (e.g., deep vein thrombosis, skin lesions, rhabdomyolysis)
- conditions preventing the outcome assessment (e.g., amputation or inability to transfer independently from bed to chair before hospital admission)
- presence of an implanted cardiac pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Luigi Gonzaga Hospital
Orbassano, TO, 10043
Federica Gamna, MD, +39 0119026994, f.gamna@sanluigi.piemonte.it
Sabrina Dal Fior, MD, +39 0119026994, s.dalfior@sanluigi.piemonte.it
About this study
Official title: Effects of Neuromuscular Electrical Stimulation Therapy on Physical Function in Patients With COVID-19 Associated Pneumonia: Study Protocol of a Randomized Controlled Trial
Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.
Read the detailed description
This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention).
NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Neuromuscular Electrical Stimulation, Physical Therapy Exercise
- Keywords
- COVID-19, Fatigue, Muscle Thickness, Neuromuscular Electrical Stimulation, Post-Intensive Care Syndrome, Quadriceps Muscle, Short Physical Performance Battery
- Medical subject headings
- COVID-19, Fatigue, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationOther
The intervention group, in addition to the daily routine physical therapy, receives NMES for 15 days (5 days per week for 3 weeks). NMES is applied bilaterally using an electrical stimulator with pairs of electrodes placed transversally on the quadriceps muscles and on the gastrocnemius muscles. The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 µs). Stimulation intensity is adjusted daily by the physical therapist to elicit a visible twitch in each muscle. The total duration of the NMES session is 30 min for the first week and 45 min for the second and third week. Stimulation (on) time is 5 s and relaxation (off) time is 15 s, thus eliciting a total of 90 evoked contractions per day during the first week and 135 contractions per day during the second and third week.
Physical Therapy ExerciseOther
The control group is subjected to a protocol of physical therapy exercises, applied once a day for 30 minutes (5 days per week for 3 weeks) by the staff physical therapists. It starts with global passive range of motion exercises, followed by active and resistive exercises (including controlled breathing exercises and respiratory muscle training), transfer to the edge of the bed or to a chair, standing and walking.
| Study group | Role | What they receive |
|---|---|---|
| NMES Group | Experimental | Not described Receives: Other: Neuromuscular Electrical Stimulation |
| Control Group | Active comparator | Not described Receives: Other: Physical Therapy Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB) Score
The SPPB score is a composite measure assessing standing balance (ability to stand for up to 10 seconds with feet positioned in three ways: together side-by-side, semi-tandem and tandem), walking speed (time to complete a 4-m walk), and sit-to- stand performance (time to rise from a chair five times). Each task is scored out of 4 points, with the scores from the three tests summed up to give a total, with a maximum of 12 points and a minimum of 0.
Measured: 1 week after the intervention
Secondary outcomes (6)
Functional Independence Measure (FIM) Scale Score
The FIM is an 18-item, clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence)
Measured: Before and 1 week after the intervention
Fatigue Severity Scale Score
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
Measured: Before and 1 week after the intervention
Muscle Strength
Handgrip strength is assessed for both sides using a handheld device. Patients are instructed to perform a maximal voluntary isometric contraction by contracting their muscles as forcefully as possible for 4-5 s. The test is repeated three times for each side and the highest value is retained. Lower limb strength is assessed as the sum of knee extension and plantar flexion strength of both sides. Muscle strength is rated using the Medical Research Council (MRC) scale that ranges from 0 (no muscle contraction) to 5 (normal resistance), for a maximum score of 20 points.
Measured: Before and 1 week after the intervention
Two Step Test Length
Subjects are required to step out with the dominant leg maximally, then to step out with the other leg maximally, and then to draw and match the first leg to the second leg while maintaining body stability with either supporting leg. The distance between the start line and the tiptoe of the second step foot is measured as the double step length (sum of the first and second steps).
Measured: 1 week after the intervention
Six Minutes Walking Test Distance
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 1 week after the intervention
Muscle Thickness
Ultrasound-derived muscle thickness is measured as the distance between the superficial and deep aponeuroses of the rectus femoris muscle (that is measured half-way along the line from the anterior-superior iliac spine to the superior border of the patella). Three consecutive static scans of the rectus femoris of both thighs are acquired in the transverse plane and the mean of six measurements (three measurements per side) is considered.
Measured: Before and 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start17 Apr 2020
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital
- Responsible party
- Principal investigator, Marco Alessandro Minetto, University of Turin, Italy
- Investigators
- Marco Alessandro Minetto, MD, PhD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382729
- Sponsor's protocol ID
- ESC270320
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation Therapy on Physical Function in Patients With COVID-19 Associated Pneumonia: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04382729
- Acronym / sponsor ID
- ESC270320
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID-19, Fatigue, Muscle Thickness, Neuromuscular Electrical Stimulation, Post-Intensive Care Syndrome, Quadriceps Muscle, Short Physical Performance Battery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.
Detailed description
This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention).
NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES Group | Experimental | Other: Neuromuscular Electrical Stimulation |
| Control Group | Active comparator | Other: Physical Therapy Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years
- respiratory (PaO2/FiO2 ratio > 180 mmHg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents
Key exclusion criteria (6 listed)
- pregnancy
- known or suspected malignancy in the lower limbs
- body mass index equal or greater than 35 kg/m2
- conditions preventing NMES treatment (e.g., deep vein thrombosis, skin lesions, rhabdomyolysis)
- conditions preventing the outcome assessment (e.g., amputation or inability to transfer independently from bed to chair before hospital admission)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Electrical StimulationThe intervention group, in addition to the daily routine physical therapy, receives NMES for 15 days (5 days per week for 3 weeks). NMES is applied bilaterally using an electrical stimulator with pairs of electrodes placed transversally on the quadriceps muscles and on the gastrocnemius muscles. The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 µs). Stimulation intensity is adjusted daily by the physical therapist to elicit a visible twitch in each muscle. The total duration of the NMES session is 30 min for the first week and 45 min for the second and third week. Stimulation (on) time is 5 s and relaxation (off) time is 15 s, thus eliciting a total of 90 evoked contractions per day during the first week and 135 contractions per day during the second and third week. | Other | NMES Group |
| Physical Therapy ExerciseThe control group is subjected to a protocol of physical therapy exercises, applied once a day for 30 minutes (5 days per week for 3 weeks) by the staff physical therapists. It starts with global passive range of motion exercises, followed by active and resistive exercises (including controlled breathing exercises and respiratory muscle training), transfer to the edge of the bed or to a chair, standing and walking. | Other | Control Group |
Primary outcome
Short Physical Performance Battery (SPPB) Score
Time frame: 1 week after the intervention
The SPPB score is a composite measure assessing standing balance (ability to stand for up to 10 seconds with feet positioned in three ways: together side-by-side, semi-tandem and tandem), walking speed (time to complete a 4-m walk), and sit-to- stand performance (time to rise from a chair five times). Each task is scored out of 4 points, with the scores from the three tests summed up to give a total, with a maximum of 12 points and a minimum of 0.
6 secondary outcomes
Functional Independence Measure (FIM) Scale Score
Time frame: Before and 1 week after the intervention
Fatigue Severity Scale Score
Time frame: Before and 1 week after the intervention
Muscle Strength
Time frame: Before and 1 week after the intervention
Two Step Test Length
Time frame: 1 week after the intervention
Six Minutes Walking Test Distance
Time frame: 1 week after the intervention
Muscle Thickness
Time frame: Before and 1 week after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Alessandro Minetto, MD, PhD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Electrical Stimulation and Physical Therapy Exercise in people with COVID-19 Pneumonia, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Alessandro Minetto, MD, PhD (+39 011 6705472, marco.minetto@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) Score (time frame: 1 week after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.