NCT04833621

Brief Summary

Background: Sarcopenia (muscle weakness) characterized by a decrease in muscle mass, strength and performance is a condition that increases with old age. Sarcopenia can be seen in 5-13% of patients hospitalized in ICU where various treatment methods are used to prevent this weakness, the rate increases in patients with sepsis/ septic shock. Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU. It is predicted that "neuromuscular electrical stimulator-NMES" treatment may increase muscle mass and strength in patients who's can not be exercised actively. In this study, the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis/ septic shock followed in intensive care units (ICU) was evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

February 19, 2021

Last Update Submit

April 4, 2021

Conditions

Intensive Care Unit Acquired WeaknessSepsis, Severe

Keywords

ICU-AWNMESsarcopeniasepsis.

Outcome Measures

Primary Outcomes (11)

  • Effects of NMES treatment on ICU-AW development, anthropometric measurement,

    The measurements of the patients were recorded as anthropometric (arm circumference and thigh circumference) on the 1st, 3rd, 7th, 14th, 21st and 28th days. Arm circumference(centimeter) measurement was measured from the thickest part of the biceps muscle(centimeter) when the elbow was flexed and thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.

    28 DAYS

  • Effects of NMES treatment on ICU-AW development, ultrasonographic measurement

    Using an ultrasound imaging device, the thickness of biceps brachii (cm\^2) and rectus femoris muscles (cm\^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.

    on the 1st, 3rd, 7th, 14th, 21st and 28th days

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.

    on the 1st, 3rd, 7th, 14th, 21st and 28th days

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.

    on the 1st, 3rd, 7th, 14th, 21st and 28th days

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.

    first day

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.

    first day

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days.

    28 days

  • Effects of NMES treatment on ICU-AW development, scoring systems.

    When the follow-up was completed, duration of the ICU stay, , last BMI (body mass index)(kg/m\^2) were recorded.

    28 days

  • Effects of NMES treatment on ICU-AW development, nutrition.

    The diet of the patients were standardized by the dietitian.

    28 days

  • height

    The height of the patients was calculated by measuring the knee height from many alternative height measurement methods. The measurement includes the length from the base of the foot to the anterior surface of the thigh while the lower extremity is flexed and is easily taken Chumlea et al. The equation created by the Chumlea method, known as the Chumlea method, is the most accurate equation used to estimate standing height from knee height. This method has been cross-validated for use in ICU patients. The original estimated equations are given. White Male Estimated height (cm) = (knee height (cm) × 1.88) + 71.85 White Female Estimated height (cm) = (knee height (cm) × 1.87) - (0.06 × age (y)) + 70.25

    first day and last day ( end of the 28th day)

  • weight

    We calculated the body weight of our patients by indirectly using the method of calculating body weight in bedridden patients. Age (Year) 6-18 Male : (Knee length (cm) x 0.68) + (Arm circumference (cm)x 2.64) -50.08 Female : (Knee (cm) x 0.77) + (Arm (cm) x 2.47) - 50.16 19-59 Male : (Knee (cm) x 1.19) + (Arm (cm) x 3.21) -86.82 Female : (Knee (cm) x 1.01) + (Arm (cm) x 2.81) - 66.04 60-80 Male : (Knee (cm) x 1.10) + (Arm (cm) x 3.07) -75.81 Female : (Knee (cm) x 1.09) + (Arm circumference(cm) x 2.68) - 65.51

    first day and last day (end of the 28th day)

Study Arms (2)

NMES GROUP

ACTIVE COMPARATOR

NMES TREATMENT AND PHYSICAL TREATMENT

Device: NMES GROUP

CONTROL GROUP

ACTIVE COMPARATOR

JUST PHYSICAL TREATMENT

Device: NMES GROUP

Interventions

NMES GROUPDEVICE

The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed

CONTROL GROUPNMES GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being in the Intensive Care Unit
  • Over the age of 18
  • Diagnosed with sepsis/ septic shock

You may not qualify if:

  • Under the age of 18
  • Pregnancy
  • Having a cardiac pacemaker
  • Amputated lower limbs
  • Having severe venous insufficiency or major injuries to their lower extremities
  • Having neuromuscular disease
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Faculty of Medicine

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SepsisSarcopenia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESIDENT

Study Record Dates

First Submitted

February 19, 2021

First Posted

April 6, 2021

Study Start

October 23, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 6, 2021

Record last verified: 2021-03

Locations

TU(1)