Can protein and pedaling save ICU Patients' muscles?

NCT ID NCT04261543

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)
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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

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Status unknown
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First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether giving more protein and starting resistance exercise early can protect muscle mass and strength in people who are critically ill and need a breathing machine. The trial compares a high-protein prescription of at least 2.2 grams per kilogram of body weight plus cycle ergometry within 24 hours of randomization against usual care, which uses lower protein and exercise at the doctor's discretion. The team will use ultrasound to measure thigh muscle size and quality, and track functional outcomes and quality of life. The study includes 51 adults who are mechanically ventilated and at high nutritional risk.

What this could mean

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

Active substance
a high-protein diet combined with early resistance exercise using a cycle ergometer
What this could lead to
If it works, this could give intensive care teams a practical way to protect muscle mass and strength in people who need a breathing machine, possibly helping them recover function faster.
What could go wrong
The trial is small, with 51 participants, and critically ill patients often cannot tolerate high protein or early exercise. Muscle measurements on ultrasound may not translate into better recovery, and the results may not apply to other intensive care units.

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

51 people

The number who actually took part.

Started

Aug 2019

Finished

Apr 2024

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

18 to 90 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. Age 18 years old and above 2. Mechanically ventilated and expected to remain mechanically ventilated for an additional 48 hours from screening 3. High nutritional risk (at least one of the following): * BMI ≤ 25 or ≥ 35 * Moderate to severe malnutrition as defined by Subjective Global Assessment (SGA) * Frailty (Clinical Frailty Scale ≥ 5 from proxy) * SARC-F (note: 'sarc-f' is the full name, not an abbreviation) questionnaire ≥ 4 * From point of screening, projected duration of mechanical ventilation of \>4 days Exclusion Criteria: 1. \>96 continuous hours of mechanical ventilation before screening 2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening 3. Pregnant (Note: post-partum and lactating patients are not excluded from the trial) 4. The responsible clinician feels that the patient either needs low or high protein 5. Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group. 6. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted) 7. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury) 8. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 9. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 10. Intracranial or spinal process affecting motor function 11. Patients in hospital \>5 days prior to ICU admission 12. Not expected to stay ≥4 days after enrollment 13. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) 14. Lower extremity injury or impairments that prevents cycling (e.g. amputation, knee/hip injury) 15. Weight ≥150 kg 16. Physician declines enrolment for Exercise

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Conditions

The condition(s) this trial relates to.

Critical Illness Motor Activity

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Malaya

    Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

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