Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patie… (NCT02509520) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes
United States60 participantsStarted 2015-05-01
Plain-language summary
Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 45 years
* Respiratory insufficiency requiring mechanical ventilation (MV)
* ICU presentation \< 6 days
* Patient or legally authorized representative able to provide written or witnessed verbal informed consent in English
* All four limbs intact and mobile
* Eligible for and able to participate in physical therapy
* Pre admission Barthel Index \>70
Exclusion Criteria:
* Acute kidney injury with a glomerular filtration rate \< 30 ml/min
* Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis
* Diagnosis of active cancer
* Acute or chronic organ transplant rejection
* Exceedingly high mechanical ventilator settings (FiO2\>60%, PEEP\>12) or alternative modes of mechanical ventilation (inverse ratio pressure control, airway pressure release ventilation)
* Severe functional impairment or physical impairment to rehabilitation
* On high dose vasopressor agents (\> 5mcg of norepinephrine or equivalent)
* Liver function tests \> 2.5 x normal limits (normal reference ranges include AST between 10 and 40 units/L or ALT between 7 and 56 units/L)
* Chronic dementia or cognitive impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on exercise, protein, and electrical stimulation to prevent muscle loss in ICU patients — given my current condition, does my doctor think I'm physically stable enough to safely participate in that kind of intervention while in intensive care?
2Since this study is 'active not recruiting,' does my care team know whether there are any similar trials still open that combine exercise and nutritional support for ICU-related muscle weakness that I might actually be able to join?
3The trial measures things like muscle mass, strength, and mobility after critical illness — are these outcomes already being tracked in my standard care, and could that data help guide my recovery even outside a formal trial?
4This is listed as Phase NA, which typically means it's more of a behavioral or device-based intervention study rather than a drug trial — what does my doctor think is currently known about the safety and effectiveness of electrical muscle stimulation for ICU patients like me?
5If I can't join this specific trial, what standard-of-care approaches does my doctor recommend to address ICU-related muscle weakness and sarcopenia during my recovery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.