ICU Acquired Weakness
Conditions
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.
Interventions
DEVICEFunctional 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.
OTHERConventional 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.
Sponsors
Western University of Health Sciences
Fresno Community Hospital and Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change of rectus femoris cross-sectional area | 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
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 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. |
| Physical function | 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 |
| Quality of life | 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. |
| Diaphragm muscle thickness | 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. |
| Hospital length of stay | Through hospital discharge, an average of 15 days | The total hospital length of stay for this admission will be calculated. |
| ICU length of stay | Through ICU discharge, an average of 11 days | The total ICU length of stay for this admission will be calculated. |
| Duration of mechanical ventilation | Through discontinuation of mechanical ventilation, an average of 10 days | The total length of time on mechanical ventilation |
| Cognition | At hospital discharge (an average of 15 days after admission) | Cognition will be assessed using the Montreal Cognitive Assessment (MoCA). |
Countries
United States
Contacts
Primary ContactRachel Dirks, PhD
Outcome results
None listed