Clinical trial NCT04382729: Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
Fatigue
Muscle Thickness
Neuromuscular Electrical Stimulation
Post-Intensive Care Syndrome
Quadriceps Muscle
Short Physical Performance Battery
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: San Luigi Gonzaga Hospital
First posted: 2020-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Physical Performance Battery (SPPB) Score
timeFrame: 1 week after the intervention
Secondary outcomes:
measure: Functional Independence Measure (FIM) Scale Score
timeFrame: Before and 1 week after the intervention
measure: Fatigue Severity Scale Score
timeFrame: Before and 1 week after the intervention
measure: Muscle Strength
timeFrame: Before and 1 week after the intervention
measure: Two Step Test Length
timeFrame: 1 week after the intervention
measure: Six Minutes Walking Test Distance
timeFrame: 1 week after the intervention
measure: Muscle Thickness
timeFrame: Before and 1 week after the intervention
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: San Luigi Gonzaga Hospital
state: TO
Study officials:
affiliation: University of Turin, Italy
name: Marco Alessandro Minetto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: