New combo therapy aims to rebuild strength in older ICU patients
NCT ID NCT05326633
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of high-protein supplements, mobility-based physical therapy, and neuromuscular electric stimulation in older adults (60+) who have been in the ICU for at least two weeks and now have muscle weakness. The goal is to see if this approach can improve muscle mass, strength, and reduce inflammation. The trial involves 78 participants and focuses on recovery after critical illness.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. LTACH admission within 72 hours 2. Age ≥ 60 years old 3. Prior ICU stay ≥ 2 weeks 4. Able to follow commands in English 5. Pre-ICU Barthel Index ≥ 70 6. Able to give consent 7. Able to perform physical therapy 8. All four limbs intact and mobile prior to LTACH admission Exclusion Criteria: 1. Acute kidney injury with a glomerular filtration rate \<15 ml/min 2. Diagnosis of severe organ dysfunction including end stage liver disease or cirrhosis 3. Diagnosis of active cancer 4. Severe functional impairment or physical impairment to rehabilitation 5. Liver function tests \>2.5x normal limits 6. Chronic dementia or cognitive impairment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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U of Maryland, Baltimore, Professional Schools IRB
Baltimore, Maryland, 21201, United States
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Other studies related to the condition(s) this trial covers.
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