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Triple therapy aims to stop muscle loss in older ICU patients

NCT ID NCT02509520

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether starting physical therapy, electric muscle stimulation, and high-protein supplements early in the ICU can prevent the muscle loss, weakness, and mental decline known as post-intensive care syndrome (PICS). The trial enrolls adults aged 45 and older who are on mechanical ventilation. Participants receive a combination of mobility exercises, electrical stimulation to leg muscles, and extra protein to support muscle health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mobility-based physical rehabilitation, neuromuscular electric stimulation, and high-protein supplements
What this could lead to
If effective, this approach could help older ICU patients recover faster, avoid long-term disability, and reduce time spent on ventilators or in care facilities.
What could go wrong
This is a small early-stage study with 60 participants, so results may not apply broadly. The interventions require careful monitoring and may not prevent all complications.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

May 2015

Expected to finish

May 2027

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

45 years and older

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: * 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

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Conditions

The condition(s) this trial relates to.

Critical Illness Muscle Weakness Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness Muscle weakness Sarcopenia

Contacts and locations

Locations

  • U of Maryland, Baltimore, Professional Schools IRB

    Baltimore, Maryland, 21201, United States

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