Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors (NCT05326633) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Effect of Protein, Mobility Therapy and Electric Stimulation on Recovery in Older ICU Survivors
United States78 participantsStarted 2027-03-01
Plain-language summary
Older ICU survivors with ICU acquired weakness (ICUAW) are malnourished, sarcopenic, and functionally debilitated as a consequence of the high burden of comorbidities common in the elderly. To address the sequalae of critical illnesses, the investigators will perform a trial incorporating an intervention that combines mobility-based physical rehabilitation (MRP), high protein supplementation (HPRO), and neuromuscular electric stimulation (NMES). The investigators will then assess both clinical and functional outcomes and determine the relationship of disability with systemic inflammation.
Who can participate
Age range
60 Years – 99 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
. LTACH admission within 72 hours
. Age ≥ 60 years old
. Prior ICU stay ≥ 2 weeks
. Able to follow commands in English
. Pre-ICU Barthel Index ≥ 70
. Able to give consent
. Able to perform physical therapy
. All four limbs intact and mobile prior to LTACH admission
Exclusion criteria
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 combines three different interventions — protein supplementation, mobility therapy, and electrical stimulation — to address muscle loss after an ICU stay; can you help me understand which of these, if any, my loved one might already be receiving as standard care, and what would actually be new or experimental here?
2Since this is listed as Early Phase 1, it sounds like researchers are still establishing the basics of safety and dosing — what does that mean for how much is known about the risks of combining these three approaches in someone who has just been critically ill?
3The trial is not yet recruiting, so how far off might enrollment actually be, and would waiting for this study potentially delay my loved one starting other rehabilitation programs that are available right now?
4The study is specifically measuring changes in muscle mass, muscle strength, and systemic inflammation — can you explain what tools or tests they would use to track those things, and what that testing burden would look like for someone still recovering from critical illness?
5Given that this trial targets ICU-acquired weakness and sarcopenia in older survivors, are there standard rehabilitation or nutritional approaches already proven to help with these conditions that my loved one should consider first, rather than waiting for an early-phase study?
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.