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Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

Primary Purpose

Critical Illness, Physical Disability, Muscle Atrophy

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.
Patients received the low-frequency neuromuscular electrical stimulation (NMES)
Patients received the medium-frequency neuromuscular electrical stimulation (NMES)
Sponsored by
Gabriel Nasri Marzuca-Nassr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring electrical stimulation therapy, skeletal muscle atrophy, critically ill patient, physical therapy, intensive care unit

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control group

Low-frequency NMES group

Medium-frequency NMES group

Arm Description

Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day.

Patients submitted to low-frequency NMES and SPT twice a day.

Patients submitted to medium-frequency NMES and SPT twice a day.

Outcomes

Primary Outcome Measures

Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Thickness of the quadriceps muscle via ultrasonography (mm).
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Quality of the quadriceps muscle via ultrasonography by Heckmatt's rating scale. Muscle quality was estimated by Heckmatt's rating scale, which scores the ultrasound images between 1-4: 1) normal echogenicity; 2) slight increase in muscle echogenicity and normal bone reflection; 3) moderate increase in muscle echogenicity and reduced bone reflection; 4) large increase in muscle echogenicity and no bone reflection.

Secondary Outcome Measures

Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
Clinical assessment of muscle strength via Medical Research Council-Sum Score (MRC-SS) (points), which ranges from 0 (complete paralysis) to 60 (normal strength).
Change in Handgrip strength while patients were in hospital stay.
Handgrip strength via digital dynamometer (kg).
Change in Functional status while patients were in Intensive Care unit (ICU).
Functional status via Functional Status Score for the Intensive Care Unit (FSS-ICU) (points). FSS-]ICU FSS-ICU score has a range of 0-35 with higher score indicating better functional status.
Change in dynamic balance while patients were in hospital stay.
Dynamic balance via Timed Up and Go Test (seconds).
Change in independence for activities of daily living while patients were in hospital stay.
Independence for activities of daily living via Barthel index (points). A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Change in quality of life prior to hospital discharge.
Quality of life via Short Form 36 (SF-36) (points). The score go from 0 to 100. Higher scores mean a better outcome.

Full Information

First Posted
February 19, 2022
Last Updated
March 9, 2022
Sponsor
Gabriel Nasri Marzuca-Nassr
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1. Study Identification

Unique Protocol Identification Number
NCT05287919
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gabriel Nasri Marzuca-Nassr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Physical Disability, Muscle Atrophy
Keywords
electrical stimulation therapy, skeletal muscle atrophy, critically ill patient, physical therapy, intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Patients received the standard physical therapy (SPT) programme only (passive mobilization) twice a day.
Arm Title
Low-frequency NMES group
Arm Type
Experimental
Arm Description
Patients submitted to low-frequency NMES and SPT twice a day.
Arm Title
Medium-frequency NMES group
Arm Type
Experimental
Arm Description
Patients submitted to medium-frequency NMES and SPT twice a day.
Intervention Type
Other
Intervention Name(s)
Patients received the standard physical therapy (SPT) programme (passive mobilization) twice a day.
Intervention Description
All participants have received standard physical therapy (SPT) sessions based on a passive range of motion mobilization protocol for the lower limbs. It consisted of a bilateral series of 10 repetitions of hip flexion, knee flexion and extension, and ankle flexion and extension. The procedure was performed twice a day: a morning (between 8am - 12pm) and an afternoon session (between 2pm - 6pm).
Intervention Type
Other
Intervention Name(s)
Patients received the low-frequency neuromuscular electrical stimulation (NMES)
Intervention Description
Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands). The low-frequency protocol consisted of 100 Hz and 400 ms width pulses, delivered in trains of 5 s ON (ramp-up time: 1 s, plateau: 3 s, ramp-down time: 1 s) and 10 s OFF. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.
Intervention Type
Other
Intervention Name(s)
Patients received the medium-frequency neuromuscular electrical stimulation (NMES)
Intervention Description
Electrical stimulation was performed twice a day after SPT. Two electrodes were attached to each thigh at the motor points of the quadriceps muscle. The point halfway between the anterior superior iliac spine and the base of the patella was used as reference and electrodes were placed 15 cm apart each other, 5 cm proximal and 10 cm distal from the reference point. After the first measurement, semi-permanent markers were used to indicate the position of electrodes. Electrical stimulation was performed using a 4-channels device (Sonopuls 492, series 4, Enraf-Nonius®, Rotterdam, Netherlands).The medium-frequency protocol had similar parameters, but a carrier frequency of 2500 Hz and burst frequency of 100 Hz. Sessions had 20 min of duration (total of 40 min/day) and the current amplitude (mA) was adjusted to the identification of visible and palpable contractions and was rectified every 3 min to sustain the initial level of contraction.
Primary Outcome Measure Information:
Title
Change in thickness of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Description
Thickness of the quadriceps muscle via ultrasonography (mm).
Time Frame
Day 1, Day 5, Day 9
Title
Change in quality of the quadriceps muscle, evaluated with ultrasonography while patients were in intensive critical unit (ICU).
Description
Quality of the quadriceps muscle via ultrasonography by Heckmatt's rating scale. Muscle quality was estimated by Heckmatt's rating scale, which scores the ultrasound images between 1-4: 1) normal echogenicity; 2) slight increase in muscle echogenicity and normal bone reflection; 3) moderate increase in muscle echogenicity and reduced bone reflection; 4) large increase in muscle echogenicity and no bone reflection.
Time Frame
Day 1, Day 5, Day 9
Secondary Outcome Measure Information:
Title
Change in Clinical assessment of muscle strength while patients were in intensive care unit (ICU).
Description
Clinical assessment of muscle strength via Medical Research Council-Sum Score (MRC-SS) (points), which ranges from 0 (complete paralysis) to 60 (normal strength).
Time Frame
Day 9, Day 11, Day 16, and Day 27
Title
Change in Handgrip strength while patients were in hospital stay.
Description
Handgrip strength via digital dynamometer (kg).
Time Frame
Day 9, Day 11, Day 16, and Day 27
Title
Change in Functional status while patients were in Intensive Care unit (ICU).
Description
Functional status via Functional Status Score for the Intensive Care Unit (FSS-ICU) (points). FSS-]ICU FSS-ICU score has a range of 0-35 with higher score indicating better functional status.
Time Frame
Day 9, Day 11, Day 16, and Day 27
Title
Change in dynamic balance while patients were in hospital stay.
Description
Dynamic balance via Timed Up and Go Test (seconds).
Time Frame
Day 16, and Day 27
Title
Change in independence for activities of daily living while patients were in hospital stay.
Description
Independence for activities of daily living via Barthel index (points). A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities.
Time Frame
Day 16, and Day 27
Title
Change in quality of life prior to hospital discharge.
Description
Quality of life via Short Form 36 (SF-36) (points). The score go from 0 to 100. Higher scores mean a better outcome.
Time Frame
Day 27
Other Pre-specified Outcome Measures:
Title
Change in days spent in Mechanical Ventilation.
Description
Number of days spent in Mechanical Ventilation use.
Time Frame
Through mechanical ventilation use completion, an average of 9 days
Title
Change in days spent in Intensive Care Unit.
Description
Number of days spent in Intensive Care Unit stay.
Time Frame
Through Intensive Care Unit stay completion, an average of 11 days
Title
Change in days spent in the hospital.
Description
Number of days spent in hospital stay.
Time Frame
Through hospital stay completion, an average of 27 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel N Marzuca-Nassr,, PT, MSc, PhD
Organizational Affiliation
Universidad de La Frontera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Faculty of Medicine, Universidad de La Frontera
City
Temuco
ZIP/Postal Code
4780000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neuromuscular Electrical Stimulation (NMES) Preserves Muscle Mass in Intensive Care Unit (ICU)

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