Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

NCT04382729 | Unknown

• 1 other identifier: ESC270320
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; Fatigue; Muscle Thickness; Neuromuscular Electrical Stimulation; Post-Intensive Care Syndrome; Quadriceps Muscle; Short Physical Performance Battery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week after the intervention

Secondary Outcomes (6)

• Functional Independence Measure (FIM) Scale Score

  Before and 1 week after the intervention

• Fatigue Severity Scale Score

  Before and 1 week after the intervention

• Muscle Strength

  Before and 1 week after the intervention

• Two Step Test Length

  1 week after the intervention

• Six Minutes Walking Test Distance

  1 week after the intervention

Study Arms (2)

NMES Group

EXPERIMENTAL

Other: Neuromuscular Electrical Stimulation

Control Group

ACTIVE COMPARATOR

Other: Physical Therapy Exercise

Interventions

Neuromuscular Electrical Stimulation OTHER

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.

NMES Group

Physical Therapy Exercise OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• San Luigi Gonzaga Hospital: collaborator

Study Sites (1)

San Luigi Gonzaga Hospital

Orbassano, TO, 10043, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Fatigue; postintensive care syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Alessandro Minetto, MD, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Alessandro Minetto, MD, PhD

CONTACT

+39 011 6705472‬; marco.minetto@unito.it

Chiara Busso, MD

CONTACT

+39 011 6705472‬; chiara.busso@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 11, 2020
• Study Start: April 17, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)