Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Primary Purpose
Critical Illness Myopathy
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sham
Sponsored by
About this trial
This is an interventional supportive care trial for Critical Illness Myopathy focused on measuring physiotherapy, neuromuscular electrical stimulation, exercise capacity
Eligibility Criteria
Inclusion Criteria:
- Diagnosis at admission: acute or acute on chronic respiratory disease
- Mechanical ventilation > 72h at inclusion
- Expected mechanical ventilation > 24h
- Informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Unidad de Vigilancia Intensiva Respiratoria (UVIR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Conventional physiotherapy with NMEs device not activated
Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)
Outcomes
Primary Outcome Measures
Exercise capacity
Test sit-to-stand
Exercise capacity
Test sit-to-stand
Secondary Outcome Measures
Muscle strength
MRC score
Muscle strength
MRC score
Muscle strength
MRC score
Muscle strength
Dynamometry
Muscle strength
MRC score and dynamometry
Muscle strength
MRC score and dynamometry
Body composition (fat free mass)
Bioelectrical impedance
Body composition (fat free mass)
Bioelectrical impedance
Body composition (fat free mass)
Bioelectrical impedance
Functional Capacity
Barthel scale
Functional Capacity
Barthel scale
Full Information
NCT ID
NCT03083652
First Posted
February 28, 2017
Last Updated
August 9, 2022
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03083652
Brief Title
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Official Title
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness Myopathy
Keywords
physiotherapy, neuromuscular electrical stimulation, exercise capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Conventional physiotherapy with NMEs device not activated
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Conventional physiotherapy with NMES device NOT activated
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Test sit-to-stand
Time Frame
<48h from ICU discharge
Title
Exercise capacity
Description
Test sit-to-stand
Time Frame
24h before hospital discharge
Secondary Outcome Measure Information:
Title
Muscle strength
Description
MRC score
Time Frame
1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Title
Muscle strength
Description
MRC score
Time Frame
<48 from ICU discharge
Title
Muscle strength
Description
MRC score
Time Frame
24h before hospital discharge
Title
Muscle strength
Description
Dynamometry
Time Frame
1st day in which collaboration of the patient is ensured (through standardized 5 questions)
Title
Muscle strength
Description
MRC score and dynamometry
Time Frame
<48 from ICU discharge
Title
Muscle strength
Description
MRC score and dynamometry
Time Frame
24h before hospital discharge
Title
Body composition (fat free mass)
Description
Bioelectrical impedance
Time Frame
<48h from inclusion
Title
Body composition (fat free mass)
Description
Bioelectrical impedance
Time Frame
<48 from ICU discharge
Title
Body composition (fat free mass)
Description
Bioelectrical impedance
Time Frame
24h before hospital discharge
Title
Functional Capacity
Description
Barthel scale
Time Frame
<24h from inclusion
Title
Functional Capacity
Description
Barthel scale
Time Frame
24h before hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis at admission: acute or acute on chronic respiratory disease
Mechanical ventilation > 72h at inclusion
Expected mechanical ventilation > 24h
Informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan-Daniel Martí, Pt,PhD
Organizational Affiliation
Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Vigilancia Intensiva Respiratoria (UVIR)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21349913
Citation
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.
Results Reference
background
PubMed Identifier
12853536
Citation
Zanotti 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.
Results Reference
result
Learn more about this trial
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
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