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.
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.
Other: Neuromuscular Electrical Stimulation
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.
Other: Physical Therapy Exercise
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
San Luigi Gonzaga Hospital
Orbassano, TO, Italy
Investigator: Federica Gamna, MD
Contact: +39 0119026994
f.gamna@sanluigi.piemonte.it
Marco Alessandro Minetto, MD, PhD
+39 011 6705472
marco.minetto@unito.it
Chiara Busso, MD
+39 011 6705472
chiara.busso@unito.it
Marco Alessandro Minetto, MD, PhD, Principal Investigator
University of Turin, Italy