Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedNovember 7, 2023
November 1, 2023
7.3 years
February 28, 2017
November 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exercise capacity
Test sit-to-stand
<48h from ICU discharge
Exercise capacity
Test sit-to-stand
24h before hospital discharge
Secondary Outcomes (11)
Muscle strength
1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
<48 from ICU discharge
Muscle strength
24h before hospital discharge
Muscle strength
1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Muscle strength
<48 from ICU discharge
- +6 more secondary outcomes
Study Arms (2)
Control
SHAM COMPARATORConventional physiotherapy with NMEs device not activated
Intervention
EXPERIMENTALConventional physiotherapy with daily 30-minutes NMEs (5 days/week)
Interventions
Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
Eligibility Criteria
You may qualify if:
- Diagnosis at admission: acute or acute on chronic respiratory disease
- Expected mechanical ventilation \> 24h
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Vigilancia Intensiva Respiratoria (UVIR)
Barcelona, 08036, Spain
Related Publications (2)
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.
PMID: 21349913BACKGROUNDZanotti 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.
PMID: 12853536RESULT
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Joan-Daniel Martí, Pt,PhD
Physiotherapist
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 20, 2017
Study Start
February 1, 2017
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
November 7, 2023
Record last verified: 2023-11