A cuff that squeezes the leg might save muscle in ICU patients
NCT ID NCT07802743
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests a rehabilitation technique called blood flow restriction training (BFRT) in adults on ventilators who develop ICU-acquired weakness, a condition of severe muscle loss. BFRT uses an inflatable cuff on the upper leg to partially restrict blood flow during low-intensity exercise, aiming to build muscle with less effort than traditional training. Researchers will randomly assign 120 patients to standard care alone, or standard care plus BFRT at one of two pressure levels, for two weeks. They will measure muscle strength, muscle size, blood inflammation markers, and recovery times to see if BFRT helps and which pressure works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Blood flow restriction training (BFRT) using an inflatable cuff on the upper leg during low-intensity exercise
- What this could lead to
- If it works, this could offer a safe way to help critically ill patients on ventilators preserve muscle and recover faster, potentially shortening hospital stays.
- What could go wrong
- This is an early-stage trial with a modest number of patients, and results may not apply to all ICU settings. The cuff could cause discomfort or circulation issues, and the optimal pressure is still unknown.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
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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18 to 75 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. Age ≥ 18 years; 2. Received invasive mechanical ventilation for ≥ 48 hours; 3. Meets the clinical diagnosis criteria for ICUAW: The patient has reached a level of consciousness that allows for reliable assessment of voluntary muscle strength, is able to execute standardized motor commands, has an MRC-SS \< 48 points, and has no other clearly identifiable cause that explains the muscle weakness; 4. RASS score of -1 to 0, and is able to cooperate with the prescribed muscle strength assessment and rehabilitation training; 5. Current vital signs and respiratory and circulatory status are stable, meeting the safety conditions for rehabilitation training, as assessed by clinical physicians and rehabilitation therapists; 6. The patient or their legal representative has signed the informed consent form, voluntarily participating in the study. Exclusion Criteria: 1. The presence of pre-existing central or peripheral nervous system diseases, neuromuscular diseases, or severe motor function disorders that significantly affect limb strength or motor function prior to ICU admission; 2. The presence of active deep vein thrombosis, pulmonary embolism, significant peripheral arterial disease, limb ischemia, or other severe lower limb vascular diseases; 3. Severe coagulation function abnormalities, active bleeding, or a clinically judged unacceptable risk of thrombosis/hemorrhage; 4. The presence of fractures, open wounds, local infections, significant skin damage, or other conditions in the target lower limb that are unsuitable for cuff compression and exercise training; 5. Recent acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmias, or other active cardiovascular diseases that are unsuitable for BFRT; 6. Instability in respiratory or circulatory status at the time of screening, or the need for new or significantly increased use of vasoactive drugs, failing to meet the safety criteria for rehabilitation training; such individuals may be rescreened after their condition stabilizes; 7. Anticipation of imminent death, or a decision to limit or withdraw life support treatment; 8. Allergy to the cuff material, or the circumference of the target limb is not compatible with the cuff being used; 9. Inability to reliably complete specified assessments such as MRC-SS after adequate arousal.
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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 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.
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Other studies related to the condition(s) this trial covers.
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