Intensive Care Unit Acquired WeaknessNCT04833621
Is NMES Treatment in Sepsis/ Septic Shock Patients Protective in Development of ICU-AW?
A study testing NMES GROUP in people with Intensive Care Unit Acquired Weakness and Sepsis, Severe, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Sepsis, Severe
- What is being tested?
- NMES GROUP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the Intensive Care Unit
- Over the age of 18
- Diagnosed with sepsis/ septic shock
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Faculty of Medicine
Samsun, Atakum, 55200
About this study
Official title: Is Neuromuscular Electrical Stimulator Treatment in Sepsis/ Septic Shock Patients Protective in the Development of Intensive Care Unit Acquired Muscle Weakness (ICU-AW)?
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.
Read the detailed description
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.
Patients and methods: In our single-center, prospective clinical study, 80 patients with a diagnosis of sepsis/ septic shock who were hospitalized in ICU were included. The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed. The day when our patients were diagnosed with sepsis was recorded as the first day of the study. Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days i.e. 3, 7, 14, 21, and 28. Sarcopenia was defined by anthropometric and ultrasonographic measurement, and all patient outcome data were recorded.
- Being tested
- NMES GROUP
- Keywords
- ICU-AW, NMES, sarcopenia, sepsis.
- Medical subject headings
- Sepsis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES GROUPDevice
The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed
| Study group | Role | What they receive |
|---|---|---|
| NMES GROUP | Active comparator | NMES TREATMENT AND PHYSICAL TREATMENT Receives: Device: NMES GROUP |
| CONTROL GROUP | Active comparator | JUST PHYSICAL TREATMENT Receives: Device: NMES GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Effects of NMES treatment on ICU-AW development, nutrition.
The diet of the patients were standardized by the dietitian.
Measured: 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
Measured: 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
Measured: first day and last day (end of the 28th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start23 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUNES COMBA CEBECI, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833621
- Sponsor's protocol ID
- 01.02.2018 V:01
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Neuromuscular Electrical Stimulator Treatment in Sepsis/ Septic Shock Patients Protective in the Development of Intensive Care Unit Acquired Muscle Weakness (ICU-AW)?
- ClinicalTrials.gov ID
- NCT04833621
- Acronym / sponsor ID
- 01.02.2018 V:01
- Keywords
- ICU-AW, NMES, sarcopenia, sepsis.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Patients and methods: In our single-center, prospective clinical study, 80 patients with a diagnosis of sepsis/ septic shock who were hospitalized in ICU were included. The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed. The day when our patients were diagnosed with sepsis was recorded as the first day of the study. Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days i.e. 3, 7, 14, 21, and 28. Sarcopenia was defined by anthropometric and ultrasonographic measurement, and all patient outcome data were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- SINGLE CENTER, PROSPECTIVE, DOUBLE BLINDED
| Arm | Type | Receives |
|---|---|---|
| NMES GROUP | Active comparator | Device: NMES GROUPNMES TREATMENT AND PHYSICAL TREATMENT |
| CONTROL GROUP | Active comparator | Device: NMES GROUPJUST PHYSICAL TREATMENT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being in the Intensive Care Unit
- Over the age of 18
- Diagnosed with sepsis/ septic shock
Key exclusion criteria (7 listed)
- Under the age of 18
- Pregnancy
- Having a cardiac pacemaker
- Amputated lower limbs
- Having severe venous insufficiency or major injuries to their lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES GROUPThe effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed | Device | CONTROL GROUP, NMES GROUP |
Primary outcome
Effects of NMES treatment on ICU-AW development, anthropometric measurement,
Time frame: 28 DAYS
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.
Effects of NMES treatment on ICU-AW development, ultrasonographic measurement
Time frame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
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.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: on the 1st, 3rd, 7th, 14th, 21st and 28th days
On the first day of the study, SOFA (Sequential Organ Failure Assessment) score,scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: first day
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: first day
On the first day of the study, APACHE-II (Acute Physiology And Chronic Health Evaluation II) scoring systems were calculated for each patients.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: 28 days
When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days.
Effects of NMES treatment on ICU-AW development, scoring systems.
Time frame: 28 days
When the follow-up was completed, duration of the ICU stay, , last BMI (body mass index)(kg/m^2) were recorded.
Effects of NMES treatment on ICU-AW development, nutrition.
Time frame: 28 days
The diet of the patients were standardized by the dietitian.
height
Time frame: first day and last day ( end of the 28th day)
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
weight
Time frame: first day and last day (end of the 28th day)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES GROUP in people with Intensive Care Unit Acquired Weakness and Sepsis, Severe, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of NMES treatment on ICU-AW development, anthropometric measurement, (time frame: 28 DAYS). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.