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Trial record 32 of 698 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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 20, 2018
Sponsor:
Information provided by (Responsible Party):
Joan-Daniel Martí Romeu, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Critical Illness Myopathy Device: Neuromuscular electrical stimulation Other: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control
Conventional physiotherapy with NMEs device not activated
Other: Sham
Conventional physiotherapy with NMES device NOT activated

Experimental: Intervention
Conventional physiotherapy with daily 30-minutes NMEs (5 days/week)
Device: Neuromuscular electrical stimulation
Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus




Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: <48h from ICU discharge ]
    Test sit-to-stand

  2. Exercise capacity [ Time Frame: 24h before hospital discharge ]
    Test sit-to-stand


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions) ]
    MRC score

  2. Muscle strength [ Time Frame: <48 from ICU discharge ]
    MRC score

  3. Muscle strength [ Time Frame: 24h before hospital discharge ]
    MRC score

  4. Muscle strength [ Time Frame: 1st day in which collaboration of the patient is ensured (through standardized 5 questions) ]
    Dynamometry

  5. Muscle strength [ Time Frame: <48 from ICU discharge ]
    MRC score and dynamometry

  6. Muscle strength [ Time Frame: 24h before hospital discharge ]
    MRC score and dynamometry

  7. Body composition (fat free mass) [ Time Frame: <48h from inclusion ]
    Bioelectrical impedance

  8. Body composition (fat free mass) [ Time Frame: <48 from ICU discharge ]
    Bioelectrical impedance

  9. Body composition (fat free mass) [ Time Frame: 24h before hospital discharge ]
    Bioelectrical impedance

  10. Functional Capacity [ Time Frame: <24h from inclusion ]
    Barthel scale

  11. Functional Capacity [ Time Frame: 24h before hospital discharge ]
    Barthel scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083652


Contacts
Contact: Joan-Daniel Martí, PT,PhD 0034932275400 ext 4190 jd.martibcn@gmail.com
Contact: Javi Martinez, PT 0034687219761 javimagu8@gmail.com

Locations
Spain
Unidad de Vigilancia Intensiva Respiratoria (UVIR) Recruiting
Barcelona, Spain, 08036
Contact: Antoni Torres, Dr    0034932275400 ext 4190    atorres@clinic.ub.es   
Contact: Miquel Ferrer, Dr    0034932275400 ext 4190    miferrer@clinic.ub.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Joan-Daniel Martí, Pt,PhD Physiotherapist

Publications of Results:
Other Publications:
Responsible Party: Joan-Daniel Martí Romeu, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03083652     History of Changes
Other Study ID Numbers: UVIR
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Joan-Daniel Martí Romeu, Hospital Clinic of Barcelona:
physiotherapy
neuromuscular electrical stimulation
exercise capacity

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes