Blood flow restriction training for ICU patients on ventilators with ICU-acquired weakness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial investigates the safety and effectiveness of blood flow restriction training added to standard ICU rehabilitation for adults with ICU-acquired weakness who are on invasive mechanical ventilation. BFRT uses an inflatable cuff on the leg to partially restrict blood flow during low-intensity exercises, aiming to preserve or improve muscle strength with less exertion. Participants must meet criteria for ICUAW, be hemodynamically stable, and able to participate in strength assessments. The study compares BFRT plus standard/recommended ICU care to standard care alone to determine potential gains in muscle strength and functional outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated Hospital of Jining Medical University
  Jining, Shandong, China Recruiting

Study contacts

• Study coordinator: Rangrang Wang
• Email: chinawrr1124@163.com
• Phone: +86 155-8877-6876

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.