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Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

NCT04382729 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-05-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • San Luigi Gonzaga Hospital

    collaborator OTHER

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Marco Alessandro Minetto, MD, PhD · University of Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382729 on ClinicalTrials.gov