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Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03083652
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Joan-Daniel Martí Romeu, Hospital Clinic of Barcelona

February 28, 2017
March 20, 2017
August 10, 2017
February 1, 2017
March 1, 2018   (Final data collection date for primary outcome measure)
  • Exercise capacity [ Time Frame: <48h from ICU discharge ]
    Test sit-to-stand
  • Exercise capacity [ Time Frame: 24h before hospital discharge ]
    Test sit-to-stand
Same as current
Complete list of historical versions of study NCT03083652 on ClinicalTrials.gov Archive Site
  • Muscle strength [ Time Frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions) ]
    MRC score
  • Muscle strength [ Time Frame: <48 from ICU discharge ]
    MRC score
  • Muscle strength [ Time Frame: 24h before hospital discharge ]
    MRC score
  • Muscle strength [ Time Frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions) ]
    Dynamometry
  • Muscle strength [ Time Frame: <48 from ICU discharge ]
    MRC score and dynamometry
  • Muscle strength [ Time Frame: 24h before hospital discharge ]
    MRC score and dynamometry
  • Body composition (fat free mass) [ Time Frame: <48h from inclusion ]
    Bioelectrical impedance
  • Body composition (fat free mass) [ Time Frame: <48 from ICU discharge ]
    Bioelectrical impedance
  • Body composition (fat free mass) [ Time Frame: 24h before hospital discharge ]
    Bioelectrical impedance
  • Functional Capacity [ Time Frame: <24h from inclusion ]
    Barthel scale
  • Functional Capacity [ Time Frame: 24h before hospital discharge ]
    Barthel scale
Same as current
Not Provided
Not Provided
 
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Critical Illness Myopathy
  • Device: Neuromuscular electrical stimulation
    Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
  • Other: Sham
    Conventional physiotherapy with NMES device NOT activated
  • Sham Comparator: Control
    Conventional physiotherapy with NMEs device not activated
    Intervention: Other: Sham
  • Experimental: Intervention
    Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)
    Intervention: Device: Neuromuscular electrical stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Same as current
March 1, 2018
March 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Joan-Daniel Martí, PT,PhD 0034932275400 ext 4190 jd.martibcn@gmail.com
Contact: Javi Martinez, PT 0034687219761 javimagu8@gmail.com
Spain
 
 
NCT03083652
UVIR
Not Provided
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
Plan to Share IPD: Undecided
Joan-Daniel Martí Romeu, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Joan-Daniel Martí, Pt,PhD Physiotherapist
Hospital Clinic of Barcelona
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP