Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

NCT ID: NCT04382729

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2020-07-31

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

NMES Group

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: 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.

Control Group

Group Type: ACTIVE_COMPARATOR

Physical Therapy Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Luigi Gonzaga Hospital

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Alessandro Minetto

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Alessandro Minetto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

San Luigi Gonzaga Hospital

Orbassano, TO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Alessandro Minetto, MD, PhD

Role: CONTACT

marco.minetto@unito.it

+39 011 6705472‬

Chiara Busso, MD

Role: CONTACT

chiara.busso@unito.it

+39 011 6705472‬

Facility Contacts

Federica Gamna, MD

Role: primary

f.gamna@sanluigi.piemonte.it

+39 0119026994

Sabrina Dal Fior, MD

Role: backup

s.dalfior@sanluigi.piemonte.it

+39 0119026994

Other Identifiers

ESC270320

Identifier Type: -

Identifier Source: org_study_id