Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age80+
SponsorUniversidad de La Frontera

About this trial

The aim of this clinical trial is to evaluate the effectiveness of Medium-Frequency Neuromuscular Electrical Stimulation, in combination with standard physical therapy, compared to standard physical therapy alone, on muscle mass, muscle strength, and functionality in critically ill patients aged 80 and over during their hospital stay. The safety of the intervention and the standardization of protocol parameters will also be assessed.

The main research questions are:

* Does the implementation of a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol, in combination with standard physical therapy, compared to standard physical therapy alone, help attenuate the loss of skeletal muscle mass, strength, and functionality in critically ill patients aged 80 and over? * Is the use of this protocol and its proposed parameters safe for critically ill patients aged 80 and over? The study will consist of applying a standardized Medium-Frequency Neuromuscular Electrical Stimulation protocol to oldest old patients admitted to the Intensive Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco, Chile. The sample will consist of oldest old participants (≥80 years), who will be randomly divided into two subgroups: a control group that will receive standard physical therapy typically provided during hospitalization, and an experimental group that will receive the same standard therapy plus Medium-Frequency Neuromuscular Electrical Stimulation, which will begin within the first 48 hours of Intensive Care Unit admission.

The following variables will be assessed in both groups (control and experimental), from Intensive Care Unit admission to hospital discharge:

* Skeletal muscle mass characteristics and evolution (quadriceps femoris and anterior tibialis muscle thickness), measured by ultrasonography. * Handgrip strength, measured using a digital hand dynamometer. * Inspiratory muscle strength, assessed using a pimometer. * Peripheral muscle strength, evaluated with the Medical Research Council Sum Score (MRC-SS). * Functionality, assessed by the Functional Status Score for the Intensive Care Unit (FSS-ICU) . * Independence in basic activities of daily living, measured using the Barthel Index. * Quality of life, evaluated using the Short Form-36 Health Survey (SF-36). * Cognitive impairment, assessed through the Montreal Cognitive Assessment (MoCA). * Frailty, measured using the Clinical Frailty Scale (CFS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

People aged 80 years or older.

Hospitalized in the Adult Critical Care Unit of Dr. Hernán Henríquez Aravena Hospital in Temuco.

Estimated mechanical ventilation time greater than 72 hours.

Disqualifiers

Patients with prior neurological complications.

Patients with severe dependence prior to admission.

Patients with difficult-to-manage hemodynamic instability.

Patients with accessory elements that limit assessment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medium Frequency Neuromuscular Electrical Stimulation (NMES)

    Device

    The medium-frequency NMES protocol, as reported in previous studies, consists of a carrier frequency of 2,500 Hz, a treatment frequency of 100 Hz, an ON time of 5 seconds (1 second ramp-up, 3 seconds contraction, and 1 second ramp-down), and an OFF time of 10 seconds. This stimulation protocol will be applied for 20 minutes per session (40 minutes of NMES per treatment day). Two electrodes will be placed on each thigh, located at the motor point of the quadriceps muscle. Electrode positions will be marked with a semi-permanent marker to ensure consistent placement across sessions.

  • Standard physical therapy

    Procedure/Surgery

    Participants of the fourth age (≥80 years old) will receive the standard physical therapy routinely provided during their hospitalization. This intervention involves passive mobilization of the lower limbs, specifically within the ranges of hip flexion, knee flexion and extension, and ankle flexion and extension. One set of 10 bilateral repetitions will be performed while the patient is under sedation in the ICU. Once the patient is awake, the mobilization protocol routinely used in the same unit will be followed.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: CONTROL GROUPOther 1 intervention
Group B: NMES GROUPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Skeletal Muscle Mass

For the assessment of muscle mass, the thickness of the quadriceps muscle-composed of the vastus intermedius and rectus femoris-and the anterior tibialis muscle will be measured using ultrasonography. For quadriceps thickness, the reference point will be the midpoint between the anterior superior iliac spine and the superior pole of the patella. At this point, the following measurements will be taken: vastus intermedius (VI), rectus femoris (RF), and total quadriceps thickness (TQ). For the anterior tibialis muscle, the reference point will be the first third of the distance between the lateral condyle of the tibia and the upper edge of the lateral malleolus. At this reference point, the image will be frozen and the thickness of the anterior tibialis muscle will be measured. For each muscle, three consecutive measurements will be taken, and the average value will be recorded in centimeters.

Time frame
ICU admission (baseline): Day 1 During ICU stay (intermediate ICU assessment): average: Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): average: Day 12-14 Prior to hospital discharge (final assessment): average: Day 18-20

Secondary outcomes

1

Change in Handgrip Strength

Handgrip strength (HS) will be assessed using a JAMAR® digital dynamometer. Grip strength will be measured in both the dominant and non-dominant hands. During the assessment, the participant will be in a long sitting position (sitting upright in bed), with shoulders adducted and without rotation, the elbow flexed at 90° close to the body, and the forearm and wrist in a neutral position. The assessed arm will be supported on a pillow. The examiner will hold the dynamometer in a vertical position, and the participant will exert their maximum grip strength for 3 seconds. Grip strength will be measured three times on each hand alternately, and the highest recorded value will be used for analysis.

Time frame
During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20
2

Change in Peripheral Muscle Strength

Peripheral muscle strength will be assessed using the Medical Research Council Sum Score (MRC-SS), which evaluates the global peripheral muscle strength of six major muscle groups during functional movements (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) on each side of the body. Each group is rated from 0 (no visible contraction) to 5 (normal strength throughout the full range of motion). Each participant will be assigned a total score ranging from 0 (total paralysis) to 60 (normal strength). Assessments will be performed from right to left and from proximal to distal, following that same sequence. Up to three optimal attempts will be allowed per muscle group, with a rest period of at least 30 seconds between attempts.

Time frame
During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20
3

Change in Inspiratory Muscle Strength

Inspiratory muscle strength will be assessed using a digital manometer (MicroRPM®, Vyaire Medical, Hoechberg, Germany). The evaluations will follow the American Thoracic Society (ATS) recommendations for respiratory muscle strength testing. Participants will be instructed to: i) perform a rapid exhalation down to residual volume, and ii) execute a maximal inhalation "with as much force as possible." The result from this measurement will be compared against predictive equations for maximal respiratory pressures, which vary based on sex and age. The highest value from three maneuvers with less than 10% variation will be recorded, with a 1-minute rest between each attempt.

Time frame
During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14 Prior to hospital discharge (final assessment): on average Day 18-20
4

Change in ICU Functionality

Functionality in the ICU will be assessed using the Chilean version of the Functional Status Score for the Intensive Care Unit (FSS-ICU). The FSS-ICU measures the level of physical assistance required for five functional activities in the intensive care setting: rolling in bed, transitioning from supine to sitting, sitting at the edge of the bed, transferring from the bed to standing, and walking. Walking will only be assessed if the participant is able to complete a 30-meter walk. Each activity is scored from 0 points (unable to perform) to 7 points (complete independence). The total score is the sum of the scores for each completed activity, with a higher score indicating greater functional mobility.

Time frame
During ICU stay (intermediate ICU assessment): on average Day 4-6 Prior to step-down unit discharge (end-of-ICU assessment): on average Day 12-14

Other outcomes

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