Clinical trial NCT03554811: Early Rehabilitation Using Functional Electrical Stimulation Assisted Supine Cycling in the Intensive Care Unit
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICU Acquired Weakness
Lead sponsor: Fresno Community Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: Western University of Health Sciences
First posted: 2018-06-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percent change of rectus femoris cross-sectional area
timeFrame: 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)
Secondary outcomes:
measure: Diaphragm muscle thickness
timeFrame: 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)
measure: Muscle strength
timeFrame: 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
measure: Muscle strength
timeFrame: 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
measure: Physical function
timeFrame: 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)
measure: Physical function
timeFrame: 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)
measure: Physical function
timeFrame: 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)
measure: Physical function
timeFrame: 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)
measure: Quality of life
timeFrame: At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge
measure: Cognition
timeFrame: At hospital discharge (an average of 15 days after admission)
measure: Hospital length of stay
timeFrame: Through hospital discharge, an average of 15 days
measure: ICU length of stay
timeFrame: Through ICU discharge, an average of 11 days
measure: Duration of mechanical ventilation
timeFrame: Through discontinuation of mechanical ventilation, an average of 10 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: Community Medical Centers
name: Paul D Smith, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: