An interventional study of Functional electrical stimulation assisted supine cycling (FESC) and Conventional early exercise and mobility interventions in ICU Acquired Weakness, sponsored by Fresno Community Hospital and Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Fresno Community Hospital and Medical Center · Not applicable, Interventional, and Prevention
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.
Fresno Community Hospital and Medical Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Other: Conventional early exercise and mobility interventions
Patients will undergo standard ICU exercise and mobility interventions.
Other: Conventional early exercise and mobility interventions
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.
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.
Percent change of rectus femoris cross-sectional area
Ultrasound measurements will be done with patients in supine position with their leg in passive extension and neutral rotation.
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)
Diaphragm muscle thickness
Thickness will be measured by ultrasound at the zone of apposition during inspiration or expiration using the intercostal approach.
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)
Muscle strength
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.
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
Muscle strength will be assessed using hand-held dynamometry
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
Physical function
Physical function will be assessed using the physical function in ICU (PFIT) test
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
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).
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
Physical function will be assessed using the short physical performance battery (SPPB)
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
Physical function will be assessed using the six-minute walk test (6MWT)
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)
Quality of life
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.
Time frame: At hospital discharge (an average of 15 days after admission), and 90 days, 6 months, and 1 year post ICU discharge
Cognition
Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).
Time frame: At hospital discharge (an average of 15 days after admission)
Hospital length of stay
The total hospital length of stay for this admission will be calculated.
Time frame: Through hospital discharge, an average of 15 days
ICU length of stay
The total ICU length of stay for this admission will be calculated.
Time frame: Through ICU discharge, an average of 11 days
Duration of mechanical ventilation
The total length of time on mechanical ventilation
Time frame: Through discontinuation of mechanical ventilation, an average of 10 days
Plan to share: No
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Fresno Community Hospital and Medical Center