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Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03554811
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : August 20, 2021
Sponsor:
Collaborator:
Western University of Health Sciences
Information provided by (Responsible Party):
Fresno Community Hospital and Medical Center

Brief Summary:
Critically ill patients in the intensive care unit are known to lose muscle mass and function at a rapid rate. Currently, there is a global recognition and shift in the ICU culture to reduce sedation and encourage exercise and mobilization early during the ICU stay. Functional stimulation assisted supine cycling can be applied to patients in the bed and does not require patient participation. This study seeks to evaluate the effect of conventional exercise and early mobilization in combination with functional stimulation assisted supine cycling applied early during the ICU on muscle mass, strength, and physical function, as well as patient-reported disability as compared to conventional exercise and early mobilization alone.

Condition or disease Intervention/treatment Phase
ICU Acquired Weakness Device: Functional electrical stimulation assisted supine cycling (FESC) Other: Conventional early exercise and mobility interventions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling Effect on Muscle Mass, Strength, Biomarkers, and Functional Outcomes as Compared With Conventional Exercise and Early Mobilization Alone in Critically Ill Patients in the Intensive Care Unit
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional electrical stimulation assisted supine cycling
Patients will start functional electrical stimulation assisted supine cycling (FESC) within 48 hours of ICU admission and will undergo up to 1 hour of supine cycling daily, 5 days per week for 28 days, or until discharge from ICU.
Device: Functional electrical stimulation assisted supine cycling (FESC)
A supine cycle ergometer attached to a six-channel stimulator will be used for FESC. Surface electrodes will be applied to the hamstrings, quadriceps, and calf muscles on both legs. Muscles will be stimulated at specific stages throughout the cycling phase. Each session will start with a 1 minute motor-driven passive cycling warm-up at a rate of 20 revolutions per minute. Patients will continue with passive, active-assisted, or active cycling, according to their level of participation. If the patients stop cycling actively, the ergometer will revert to passive cycling.

Other: Conventional early exercise and mobility interventions
These interventions will be based on the patient's alertness and medical stability, and includes activities to maintain or increase limb range of motion and strength, in and out of bed mobility, sit to stand, and transfer training, as well as assisted ambulation.

Active Comparator: Conventional early exercise and mobility interventions
Patients will undergo standard ICU exercise and mobility interventions.
Other: Conventional early exercise and mobility interventions
These interventions will be based on the patient's alertness and medical stability, and includes activities to maintain or increase limb range of motion and strength, in and out of bed mobility, sit to stand, and transfer training, as well as assisted ambulation.




Primary Outcome Measures :
  1. Percent change of rectus femoris cross-sectional area [ Time Frame: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Ultrasound measurements will be done with patients in supine position with their leg in passive extension and neutral rotation.


Secondary Outcome Measures :
  1. Diaphragm muscle thickness [ Time Frame: Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Thickness will be measured by ultrasound at the zone of apposition during inspiration or expiration using the intercostal approach.

  2. Muscle strength [ Time Frame: Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU and hospital discharge (an average of 11 and 15 days after admission, respectively), and at 90 days, 6 months, and 1 year post ICU discharge ]
    Muscle strength will be assessed using the Medical Research Council Scale. This muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle. Weaker muscles will range from 0-3 and stronger muscles will receive grades 4 or 5.

  3. Muscle strength [ Time Frame: Baseline (within 24 hours of enrollment), weekly in the ICU (up to a maximum of 28 days), at ICU and hospital discharge (an average of 11 and 15 days after admission, respectively), and at 90 days, 6 months, and 1 year post ICU discharge ]
    Muscle strength will be assessed using hand-held dynamometry

  4. Physical function [ Time Frame: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Physical function will be assessed using the physical function in ICU (PFIT) test

  5. Physical function [ Time Frame: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Physical function will be assessed using the functional status score in the ICU (FSS-ICU). This score consists of 3 pre-ambulation categories (rolling; supine to sit transfer; and unsupported sitting) and 2 ambulation categories (sit to stand transfers; ambulation). Each category is scored from 1 (total dependent assistance) to 7 (complete independence) with a total score range of 0-35 (0: unable to perform a task due to physical limitations or medical status).

  6. Physical function [ Time Frame: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Physical function will be assessed using the short physical performance battery (SPPB)

  7. Physical function [ Time Frame: Baseline (within 24 hours of enrollment), weekly during ICU admission (up to a maximum of 28 days), at ICU discharge (an average of 11 days after admission), and at hospital discharge (an average of 15 days after admission) ]
    Physical function will be assessed using the six-minute walk test (6MWT)

  8. Quality of life [ Time Frame: At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge ]
    Quality of life will be measured using the 36-item Short Health Survey (SF-36), which assess eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale and items in the same category are averaged together to create the 8 scale scores, with 0 being the lowest score and 100 being the highest for each category.

  9. Cognition [ Time Frame: At hospital discharge (an average of 15 days after admission) ]
    Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).

  10. Hospital length of stay [ Time Frame: Through hospital discharge, an average of 15 days ]
    The total hospital length of stay for this admission will be calculated.

  11. ICU length of stay [ Time Frame: Through ICU discharge, an average of 11 days ]
    The total ICU length of stay for this admission will be calculated.

  12. Duration of mechanical ventilation [ Time Frame: Through discontinuation of mechanical ventilation, an average of 10 days ]
    The total length of time on mechanical ventilation



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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:

  • ≥ 18 years of age
  • Admitted to the ICU with a predicted ICU length of stay ≥ 4 days
  • Expected to survive the ICU stay
  • Expected to receive mechanical ventilation > 48 hours
  • Able to perform physical outcome measures pre-morbidly (with or without an assisted device)

Exclusion Criteria:

  • Proven or suspected neuromuscular weakness affecting the legs (eg- stroke or Guillain-Barré syndrome)
  • Lower limb amputation(s)
  • Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 36 hours
  • Pregnancy
  • Body mass index > 40
  • Presence of external fixator or superficial metal in lower limb
  • Open wounds or skin abrasions at electrode application points
  • Presence of pacemaker or implanted defibrillator
  • Transferred from another ICU after >48 hours of consecutive mechanical ventilation
  • Lower limb malignancy
  • Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions
  • Body habitus unable to fit the bike
  • Palliative goals of care
  • Unable to participate in FESC within 48 hours of ICU admission due to logistic reasons or due to failure in daily screening for participation

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): NCT03554811


Contacts
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Contact: Rachel Dirks, PhD 559-459-4029 rdirks@communitymedical.org

Locations
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United States, California
Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Contact: Paul Smith         
Sponsors and Collaborators
Fresno Community Hospital and Medical Center
Western University of Health Sciences
Investigators
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Principal Investigator: Paul D Smith, PT, DPT Community Medical Centers
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Responsible Party: Fresno Community Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT03554811    
Other Study ID Numbers: 2018015
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes