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New combo therapy aims to rebuild strength in older ICU patients

NCT ID NCT05326633

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

60 to 99 years

Sex

Anyone

Healthy volunteers

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

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.

Critical Illness critical illness polyneuropathy Sarcopenia

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • U of Maryland, Baltimore, Professional Schools IRB

    Baltimore, Maryland, 21201, United States

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