Neuromuscular Electrical StimulationNCT05465291
Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients
A study testing Exercise group, Neuromuscular Electrical Muscle Stimulation group and Neuromuscular Electrical Muscle Stimulation and Exercise group in people with Neuromuscular Electrical Stimulation and ICU Acquired Muscle Weakness, run by Damanhour University at 1 site in Egypt.
Trial summary
Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Electrical Stimulation, ICU Acquired Muscle Weakness
- What is being tested?
- Exercise group, Neuromuscular Electrical Muscle Stimulation group and Neuromuscular Electrical Muscle Stimulation and Exercise group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2022to 18 Feb 2023
- 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
- aged ≥18 years,
- mechanically ventilated for ≥48 h
- remain in the intensive care ≥4 days.
Who cannot join
- Pre-existing neuromuscular disease
- brain death
- peripheral vascular diseases (arterial lower limb disease and deep venous thrombosis)
- hemiplegia/quadriplegia
- lower limb amputation
- spinal injuries
Show all 10Show fewer
- receiving muscle relaxant; cognitive impairment; body mass index (BMI) > 35 kg/m2; bone fractures
- skin lesions
- presence of cardiac pacemaker
- end-stage cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial
Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Up to 25% of patients requiring mechanical ventilation (MV) for greater than 7 days develop ICUAW, and this figure may rise to 50-100% in the septic population. Long-term follow-up studies of survivors of critical illness have demonstrated significantly impaired health-related quality of life and physical functioning up to 5 years after ICU discharge, with weakness being the most commonly reported physical limitation. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to cooperate. An intervention that begins early in ICU admission without the need for patient volition may be beneficial in attenuating muscle wasting. Therefore, this study aims to evaluate the effect of neuromuscular electrical stimulation and early physical activity on ICU acquired muscle weakness in mechanically ventilated patient
Read the detailed description
A randomized controlled study will be carried out to achieve the aim of the current study. For three months, from July 15, 2022 to September 15, 2022, newly admitted patients will be screened. Patients in this trial will be recruited prospectively within 24 hours of admission to the general ICU. Computer-generated randomization will be used to assign patients to one of four groups: neuromuscular electrical stimulation (NMES), exercise (EX); combined therapy (NMES + EX); or conventional care (control group). A minimum total sample size of 120 samples will be included. According to sample size calculations treatment groups (NMES, EX, NMES + EX or conventional care) would be represented by a minimum of 30 patients. A total sample size a 120 will be selected for the study. All patients in the four groups will receive ICU standard care which includes sedation and weaning protocols.
Conventional care (Control Group):
Patients in this group will receive usual physiotherapy consisting of in-bed EXs and ICU standard care.
Exercise group (EX Group):
This group will receive passive/active exercise range of motion (ROM) exercises . ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied the second day of 1CU admission for seven days.
Neuromuscular Electrical Muscle Stimulation (NEMS Group):
Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for seven days.
Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day after admission for seven days.
Combined therapy (NMES + EX):
Patients in this group will be subjected to NMES pulse EX. The application of NMES occurring simultaneously to the upper and lower limbs exercises.
The ICU acquired muscle weakness assessment tool will be developed by the researchers to assess and record occurrence of ICUAMW.
- Being tested
- Exercise group, Neuromuscular Electrical Muscle Stimulation group, Neuromuscular Electrical Muscle Stimulation and Exercise group
- Keywords
- Mechanical ventilation, Rehabilitation, Critical care, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupProcedure or surgery
Also called EX Group
This group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission .
Neuromuscular Electrical Muscle Stimulation groupProcedure or surgery
Also called NEMS group
- Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission.
- Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day till seventh day of admission .
Neuromuscular Electrical Muscle Stimulation and Exercise groupProcedure or surgery
Also called NMES + EX group
Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.
| Study group | Role | What they receive |
|---|---|---|
| Conventional care | No intervention | Control Group |
| Exercise Group | Experimental | Passive/active range of motion exercises group Receives: Procedure: Exercise group |
| Neuromuscular Electrical Muscle Stimulation group | Experimental | Neuromuscular Electrical Muscle Stimulation group Receives: Procedure: Neuromuscular Electrical Muscle Stimulation group |
| Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise) | Experimental | Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise). Receives: Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing a change in limb muscle strength
Limb muscle strength using Medical Research Council score (MRCS). Three muscle groups in all four limbs will be assessed with the MRC scale with values ranging from 0 (quadriplegia….severe muscle weakness) to 60 (normal muscle strength).
Measured: on day 2 of ICU admission, on day 3, and on day 5.
Secondary outcomes (3)
Time to weaning off the ventilator
Time to weaning off the ventilator
Measured: After day 2 of ICU admission and on day 5.
Duration of MV
Duration of mechanical ventilation
Measured: After day 2 of ICU admission and on day 5.
ICU length of stay
ICU length of stay
Measured: After day 2 of ICU admission and on day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start18 Oct 2022
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Electrical StimulationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Younes, Damanhour University
- Investigators
- Sahar Y Othman, Assit. Prof., Principal investigator, Faculty of Nursing, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465291
- Sponsor's protocol ID
- Neuromuscular stimulation
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cusack R, Bates A, Mitchell K, van Willigen Z, Denehy L, Hart N, Dushianthan A, Reading I, Chorozoglou M, Sturmey G, Davey I, Grocott M. Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.
PubMed 35428629McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
PubMed 25316527Cerqueira TCF, de Cerqueira Neto ML, Cacau LAP, de Araujo Filho AA, Oliveira GU, da Silva Junior WM, Carvalho VO, de Mendonca JT, de Santana Filho VJ. Effect of neuromuscular electrical stimulation on functional exercise capacity in patients undergoing cardiac surgery: A randomized clinical trial. Clin Rehabil. 2022 Jun;36(6):789-800. doi: 10.1177/02692155211070945. Epub 2021 Dec 31.
PubMed 34971331Gomes Neto M, Oliveira FA, Reis HF, de Sousa Rodrigues- E Jr, Bittencourt HS, Oliveira Carvalho V. Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 May-Jun;36(3):157-66. doi: 10.1097/HCR.0000000000000151.
PubMed 26784735Sumin AN, Oleinik PA, Bezdenezhnykh AV, Ivanova AV. Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22769. doi: 10.1097/MD.0000000000022769.
PubMed 33080746Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review. J Rehabil Med. 2021 Mar 18;53(3):jrm00164. doi: 10.2340/16501977-2805.
PubMed 33634830
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation and Early Physical Activity on ICU Acquired Muscle Weakness in Mechanically Ventilated Patient: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05465291
- Acronym / sponsor ID
- Neuromuscular stimulation
- Keywords
- Mechanical ventilation, Rehabilitation, Critical care, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 19 Jul 2022 (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.
Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Up to 25% of patients requiring mechanical ventilation (MV) for greater than 7 days develop ICUAW, and this figure may rise to 50-100% in the septic population. Long-term follow-up studies of survivors of critical illness have demonstrated significantly impaired health-related quality of life and physical functioning up to 5 years after ICU discharge, with weakness being the most commonly reported physical limitation. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to cooperate. An intervention that begins early in ICU admission without the need for patient volition may be beneficial in attenuating muscle wasting. Therefore, this study aims to evaluate the effect of neuromuscular electrical stimulation and early physical activity on ICU acquired muscle weakness in mechanically ventilated patient
Detailed description
A randomized controlled study will be carried out to achieve the aim of the current study. For three months, from July 15, 2022 to September 15, 2022, newly admitted patients will be screened. Patients in this trial will be recruited prospectively within 24 hours of admission to the general ICU. Computer-generated randomization will be used to assign patients to one of four groups: neuromuscular electrical stimulation (NMES), exercise (EX); combined therapy (NMES + EX); or conventional care (control group). A minimum total sample size of 120 samples will be included. According to sample size calculations treatment groups (NMES, EX, NMES + EX or conventional care) would be represented by a minimum of 30 patients. A total sample size a 120 will be selected for the study. All patients in the four groups will receive ICU standard care which includes sedation and weaning protocols.
Conventional care (Control Group):
Patients in this group will receive usual physiotherapy consisting of in-bed EXs and ICU standard care.
Exercise group (EX Group):
This group will receive passive/active exercise range of motion (ROM) exercises . ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied the second day of 1CU admission for seven days.
Neuromuscular Electrical Muscle Stimulation (NEMS Group):
Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for seven days.
Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day after admission for seven days.
Combined therapy (NMES + EX):
Patients in this group will be subjected to NMES pulse EX. The application of NMES occurring simultaneously to the upper and lower limbs exercises.
The ICU acquired muscle weakness assessment tool will be developed by the researchers to assess and record occurrence of ICUAMW.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional care | No intervention | –Control Group |
| Exercise Group | Experimental | Procedure: Exercise groupPassive/active range of motion exercises group |
| Neuromuscular Electrical Muscle Stimulation group | Experimental | Procedure: Neuromuscular Electrical Muscle Stimulation groupNeuromuscular Electrical Muscle Stimulation group |
| Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise) | Experimental | Procedure: Neuromuscular Electrical Muscle Stimulation and Exercise groupCombined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥18 years,
- mechanically ventilated for ≥48 h
- remain in the intensive care ≥4 days.
Key exclusion criteria (10 listed)
- Pre-existing neuromuscular disease
- brain death
- peripheral vascular diseases (arterial lower limb disease and deep venous thrombosis)
- hemiplegia/quadriplegia
- lower limb amputation
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 |
|---|---|---|
| Exercise groupAlso: EX GroupThis group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission . | Procedure or surgery | Exercise Group |
| Neuromuscular Electrical Muscle Stimulation groupAlso: NEMS group* Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission. * Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day till seventh day of admission . | Procedure or surgery | Neuromuscular Electrical Muscle Stimulation group |
| Neuromuscular Electrical Muscle Stimulation and Exercise groupAlso: NMES + EX groupPatients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise. | Procedure or surgery | Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise) |
Primary outcome
Assessing a change in limb muscle strength
Time frame: on day 2 of ICU admission, on day 3, and on day 5.
Limb muscle strength using Medical Research Council score (MRCS). Three muscle groups in all four limbs will be assessed with the MRC scale with values ranging from 0 (quadriplegia….severe muscle weakness) to 60 (normal muscle strength).
3 secondary outcomes
Time to weaning off the ventilator
Time frame: After day 2 of ICU admission and on day 5.
Duration of MV
Time frame: After day 2 of ICU admission and on day 5.
ICU length of stay
Time frame: After day 2 of ICU admission and on day 5.
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 11 Apr 2023.
- Background: PubMed 35428629Cusack R, Bates A, Mitchell K, van Willigen Z, Denehy L, Hart N, Dushianthan A, Reading I, Chorozoglou M, Sturmey G, Davey I, Grocott M. Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.
- Background: PubMed 25316527McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
- Background: PubMed 34971331Cerqueira TCF, de Cerqueira Neto ML, Cacau LAP, de Araujo Filho AA, Oliveira GU, da Silva Junior WM, Carvalho VO, de Mendonca JT, de Santana Filho VJ. Effect of neuromuscular electrical stimulation on functional exercise capacity in patients undergoing cardiac surgery: A randomized clinical trial. Clin Rehabil. 2022 Jun;36(6):789-800. doi: 10.1177/02692155211070945. Epub 2021 Dec 31.
- Background: PubMed 26784735Gomes Neto M, Oliveira FA, Reis HF, de Sousa Rodrigues- E Jr, Bittencourt HS, Oliveira Carvalho V. Effects of Neuromuscular Electrical Stimulation on Physiologic and Functional Measurements in Patients With Heart Failure: A SYSTEMATIC REVIEW WITH META-ANALYSIS. J Cardiopulm Rehabil Prev. 2016 May-Jun;36(3):157-66. doi: 10.1097/HCR.0000000000000151.
- Background: PubMed 33080746Sumin AN, Oleinik PA, Bezdenezhnykh AV, Ivanova AV. Neuromuscular electrical stimulation in early rehabilitation of patients with postoperative complications after cardiovascular surgery: A randomized controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22769. doi: 10.1097/MD.0000000000022769.
- Results publication: PubMed 33634830Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative review. J Rehabil Med. 2021 Mar 18;53(3):jrm00164. doi: 10.2340/16501977-2805.
- Individual participant dataSharing planned: No
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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.
Sahar Y Othman, Assit. Prof. principal investigator
Faculty of Nursing, Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group, Neuromuscular Electrical Muscle Stimulation group and Neuromuscular Electrical Muscle Stimulation and Exercise group in people with Neuromuscular Electrical Stimulation and ICU Acquired Muscle Weakness, run by Damanhour University at 1 site in Egypt.
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 10 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 11 Apr 2023. 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 Egypt. 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?
Assessing a change in limb muscle strength (time frame: on day 2 of ICU admission, on day 3, and on day 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465291, which also lists 6 linked publications.
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 11 Apr 2023.