Neuromuscular Electrical Stimulation in Critically Ill Patients Aged 80 and Over

NCT07127991 | Not Yet Recruiting

• 1 other identifier: 234
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Intensive Care Units (ICUs); Muscle Atrophy or Weakness; Old and Very Old People

Keywords

MUSCLE ATROPHY; FUNCTIONAL STATUS; ICU; OLDER ADULTS; NMES

Outcome Measures

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.

  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 (8)

• Change in Handgrip Strength

  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

• Change in Peripheral Muscle Strength

  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

• Change in Inspiratory Muscle Strength

  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

• Change in ICU Functionality

  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

• Change in Independence in Performing Activities of Daily Living

  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

Study Arms (2)

CONTROL GROUP

OTHER

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. This intervention will be carried out twice a day: the first session in the morning (08:00-12:00 hrs) and the second in the afternoon (14:00-18:00 hrs). This corresponds to the standard practice in the ICU of Dr. Hernán Henríquez Aravena Hospital.

Procedure: Standard physical therapy

NMES GROUP

EXPERIMENTAL

The participant will receive standard physical therapy plus medium-frequency NMES. Two sessions will be carried out-one in the morning (08:00-12:00 hrs) and another in the afternoon (14:00-18:00 hrs)-always following standard physical therapy.

Device: Medium Frequency Neuromuscular Electrical Stimulation (NMES); Procedure: Standard physical therapy

Interventions

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.

NMES GROUP

Standard physical therapy PROCEDURE

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.

CONTROL GROUP; NMES GROUP

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with lower limb amputation.
• Patients in the prone position.
• Patients with loss of skin integrity.
• Patients expected to remain in the unit for less than 72 hours.
• Patients transferred from other services with a stay of more than 72 hours.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Hospital Dr Hernán Henríquez Aravena

Temuco, Región de la Araucanía, 4580000, Chile

Location

Related Publications (1)

• Wageck B, Nunes GS, Silva FL, Damasceno MC, de Noronha M. Application and effects of neuromuscular electrical stimulation in critically ill patients: systematic review. Med Intensiva. 2014 Oct;38(7):444-54. doi: 10.1016/j.medin.2013.12.003. Epub 2014 Jul 22.

  PMID: 25060511 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy; Asthenia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Gabriel Nasri Marzuca-Nassr, PhD

  Universidad de La Frontera

  STUDY CHAIR

Central Study Contacts

Ruud S Teppa-Zyl, Master's degree

CONTACT

+56 945259435; ruudteppaz@gmail.com

Gabriel Nasri Marzuca-Nassr, PhD

CONTACT

+56 45 2596713; gabriel.marzuca@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking will be single-blind. The data analyst will receive the database with groups coded as A/B and will not have access to the allocation key until the primary analyses are completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in the Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera, Temuco, Chile.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)