Critical Illness MyopathyNCT03083652
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
A study testing Neuromuscular electrical stimulation in people with Critical Illness Myopathy, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Myopathy
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to 1 Jun 2024
- 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
- Diagnosis at admission: acute or acute on chronic respiratory disease
- Mechanical ventilation > 72h at inclusion
- Expected mechanical ventilation > 24h
- Informed consent
Who cannot join
- Patients re-admitted to ICU (no hospital discharge)
- Exitus or transfer to another service/hospital
- Respiratory instability [Inspired fraction of oxygen (FIO2) >60% or positive end-expiratory pressure (PEEP) >10 cmH2O] and/or hemodynamic instability [Mean arterial pressure ( MAP)<60mmHg although vasoactive drugs] during > 24h.
- Pregnancy
- Neuromuscular disease before admission
- Skin lesions
- Limitation of therapeutic effort
- Mental and/or physical limitation to understand/realize tests for evaluation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Unidad de Vigilancia Intensiva Respiratoria (UVIR)
Barcelona, 08036
Antoni Torres, Dr, 0034932275400 ext. 4190, atorres@clinic.ub.es
Miquel Ferrer, Dr, 0034932275400 ext. 4190, miferrer@clinic.ub.es
About this study
Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.
- Conditions
- Critical Illness Myopathy
- Being tested
- Neuromuscular electrical stimulation, Sham
- Keywords
- physiotherapy, neuromuscular electrical stimulation, exercise capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
ShamOther
Conventional physiotherapy with NMES device NOT activated
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Conventional physiotherapy with NMEs device not activated Receives: Other: Sham |
| Intervention | Experimental | Conventional physiotherapy with daily 30-minutes NMEs (5 days/week) Receives: Device: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Test sit-to-stand
Measured: <48h from ICU discharge
Exercise capacity
Test sit-to-stand
Measured: 24h before hospital discharge
Secondary outcomes (11)
Muscle strength
MRC score
Measured: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
MRC score
Measured: <48 from ICU discharge
Muscle strength
MRC score
Measured: 24h before hospital discharge
Muscle strength
Dynamometry
Measured: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
MRC score and dynamometry
Measured: <48 from ICU discharge
Muscle strength
MRC score and dynamometry
Measured: 24h before hospital discharge
Body composition (fat free mass)
Bioelectrical impedance
Measured: <48h from inclusion
Body composition (fat free mass)
Bioelectrical impedance
Measured: <48 from ICU discharge
Body composition (fat free mass)
Bioelectrical impedance
Measured: 24h before hospital discharge
Functional Capacity
Barthel scale
Measured: <24h from inclusion
Functional Capacity
Barthel scale
Measured: 24h before hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Feb 2017
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical Illness MyopathyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan-Daniel Martí Romeu, Hospital Clinic of Barcelona
- Investigators
- Joan-Daniel Martí, Pt,PhD, Principal investigator, Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083652
- Sponsor's protocol ID
- UVIR
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdellaoui A, Prefaut C, Gouzi F, Couillard A, Coisy-Quivy M, Hugon G, Molinari N, Lafontaine T, Jonquet O, Laoudj-Chenivesse D, Hayot M. Skeletal muscle effects of electrostimulation after COPD exacerbation: a pilot study. Eur Respir J. 2011 Oct;38(4):781-8. doi: 10.1183/09031936.00167110. Epub 2011 Feb 24.
PubMed 21349913Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bed-bound patients with COPD receiving mechanical ventilation: effect of electrical stimulation. Chest. 2003 Jul;124(1):292-6. doi: 10.1378/chest.124.1.292.
PubMed 12853536
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03083652
- Acronym / sponsor ID
- UVIR
- Conditions
- Critical Illness Myopathy
- Keywords
- physiotherapy, neuromuscular electrical stimulation, exercise capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 20 Mar 2017 (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.
Neuromuscular electrical stimulation (NMES) implemented during the intensive care unit(ICU) stay may improve exercise capacity and prevent muscular weakness in critically ill patients with respiratory disease. Main objective: To evaluate, in respiratory critically ill patients, the effects of a conventional physiotherapy program with or without additional NMES applied only during the ICU stay on exercise capacity. Design: Randomized, controlled, double-blind clinical trial on patients (>18yo) with diagnosis on admission of acute or acute on chronic respiratory disease, on mechanical ventilation (MV) > 72h and expected MV > 24h. Intervention: Conventional physiotherapy with or without 30-minutes (5days/week) on quadriceps femoris and gluteus maximus. Patients in the control group will follow the same protocol but the device will not be activated. Measures: Demographic data, body composition through bioelectrical impedance analysis (BIA), and functional capacity before admission through Barthel scale will be registered upon inclusion. Exercise capacity through test sit-to stand, muscular strength through Medical Research Council (MRC) score and dynamometry, body composition through BIA, and functional capacity through Barthel scale will be obtained at ICU and hospital discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: ShamConventional physiotherapy with NMEs device not activated |
| Intervention | Experimental | Device: Neuromuscular electrical stimulationConventional physiotherapy with daily 30-minutes NMEs (5 days/week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis at admission: acute or acute on chronic respiratory disease
- Mechanical ventilation > 72h at inclusion
- Expected mechanical ventilation > 24h
- Informed consent
Key exclusion criteria (8 listed)
- Patients re-admitted to ICU (no hospital discharge)
- Exitus or transfer to another service/hospital
- Respiratory instability [Inspired fraction of oxygen (FIO2) >60% or positive end-expiratory pressure (PEEP) >10 cmH2O] and/or hemodynamic instability [Mean arterial pressure ( MAP)<60mmHg although vasoactive drugs] during > 24h.
- Pregnancy
- Neuromuscular disease before admission
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 |
|---|---|---|
| Neuromuscular electrical stimulationNeuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus | Device | Intervention |
| ShamConventional physiotherapy with NMES device NOT activated | Other | Control |
Primary outcome
Exercise capacity
Time frame: <48h from ICU discharge
Test sit-to-stand
Exercise capacity
Time frame: 24h before hospital discharge
Test sit-to-stand
11 secondary outcomes
Muscle strength
Time frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
Time frame: <48 from ICU discharge
Muscle strength
Time frame: 24h before hospital discharge
Muscle strength
Time frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
Time frame: <48 from ICU discharge
Muscle strength
Time frame: 24h before hospital discharge
Body composition (fat free mass)
Time frame: <48h from inclusion
Body composition (fat free mass)
Time frame: <48 from ICU discharge
Body composition (fat free mass)
Time frame: 24h before hospital discharge
Functional Capacity
Time frame: <24h from inclusion
Functional Capacity
Time frame: 24h before hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 21349913Abdellaoui A, Prefaut C, Gouzi F, Couillard A, Coisy-Quivy M, Hugon G, Molinari N, Lafontaine T, Jonquet O, Laoudj-Chenivesse D, Hayot M. Skeletal muscle effects of electrostimulation after COPD exacerbation: a pilot study. Eur Respir J. 2011 Oct;38(4):781-8. doi: 10.1183/09031936.00167110. Epub 2011 Feb 24.
- Results publication: PubMed 12853536Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral muscle strength training in bed-bound patients with COPD receiving mechanical ventilation: effect of electrical stimulation. Chest. 2003 Jul;124(1):292-6. doi: 10.1378/chest.124.1.292.
- 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.
Joan-Daniel Martí, Pt,PhD principal investigator
Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Critical Illness Myopathy, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Nov 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan-Daniel Martí, PT,PhD (0034932275400 ext. 4190, jd.martibcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: <48h from ICU discharge). The study lists 2 primary outcomes in all. 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 NCT03083652, which also lists 2 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 7 Nov 2023.