Clinical trial NCT05287919: Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)
Official title: Effects of Low- and Medium-frequency Neuromuscular Electrical Stimulation on Skeletal Muscle Atrophy in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Physical Disability
Muscle Atrophy
Keywords: electrical stimulation therapy
skeletal muscle atrophy
critically ill patient
physical therapy
intensive care unit
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Objective: to compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were strength, functionality, independence for activities of daily living, quality of life, and total days hospitalized.

Detailed description: Background: Low-frequency neuromuscular electrical stimulation (NMES) attenuates the loss of muscle mass of Intensive Care Unit (ICU) patients. However, it has been shown that medium-frequency NMES may be better than low-frequency for the maintenance of skeletal muscle mass in healthy subjects.

Research question: The research question was is medium-frequency neuromuscular electrical stimulation (NMES) more effective than low-frequency NMES for the attenuation of skeletal muscle atrophy in critically ill patients?

Objective: To compare the effects of low-frequency and medium-frequency NMES, along with a standard physical therapy (SPT) programme, on the attenuation of skeletal muscle atrophy in critically ill patients.

Methods: Fifty-four critically ill patients admitted into intensive care unit (ICU) and on mechanical ventilation (MV) participated in this randomized, single-blinded, experimental study. Participants were allocated to one of the following groups: Control Group (CG), received a standard lower limb physical therapy (SPT) programme, 2x/day; Low-frequency NMES Group (LFG), received lower limb SPT+NMES at 100 Hz, 2x/day; and Medium-frequency NMES Group (MFG), received lower limb SPT+NMES at 100 Hz and carrier frequency of 2500 Hz, 2x/day. The primary outcome was the thickness and quality of the quadriceps muscle, evaluated with ultrasonography while patients were in ICU. Secondary outcomes, assessed at various stages of recovery, were muscle strength (MRC-SS), handgrip strength (dynamometry), functional status (FSS-ICU), degree of independence for activities of daily living (Barthel Index), functional mobility and dynamic balance (Timed Up and Go Test), quality of life (SF-36), and total days hospitalized.

Eligibility criteria: Inclusion Criteria:

- patients between 18-80 years old admitted in ICU with requirement of mechanical ventilation (MV) for longer than 72 h.

Exclusion Criteria:

* non-sedated patients;
* spinal cord injury;
* cerebrovascular accident;
* patients with pacemakers;
* history of deep vein thrombosis;
* pregnancy;
* cardiac complications (history of myocardial infarction or congenital diseases);
* use of neuromuscular blockers;
* polytraumatized patients requiring tutor support.

Primary outcomes:
measure: Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
timeFrame: Day 1, Day 5, Day 9
measure: Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
timeFrame: Day 1, Day 5, Day 9
Secondary outcomes:
measure: Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
timeFrame: Day 9, Day 11, Day 16, and Day 27
measure: Change in Handgrip strength while patients were in hospital stay.
timeFrame: Day 9, Day 11, Day 16, and Day 27
measure: Change in Functional status while patients were in Intensive Care unit (ICU).
timeFrame: Day 9, Day 11, Day 16, and Day 27
measure: Change in dynamic balance while patients were in hospital stay.
timeFrame: Day 16, and Day 27
measure: Change in independence for activities of daily living while patients were in hospital stay.
timeFrame: Day 16, and Day 27
measure: Change in quality of life prior to hospital discharge.
timeFrame: Day 27
Other outcomes:
measure: Change in days spent in Mechanical Ventilation.
timeFrame: Through mechanical ventilation use completion, an average of 9 days
measure: Change in days spent in Intensive Care Unit.
timeFrame: Through Intensive Care Unit stay completion, an average of 11 days
measure: Change in days spent in the hospital.
timeFrame: Through hospital stay completion, an average of 27 days
Locations:
city: Temuco
country: Chile
facility: Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Gabriel N Marzuca-Nassr,, PT, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: