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NCT07802743

Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness

Sponsor: Affiliated Hospital of Jining Medical University

View on ClinicalTrials.gov

Summary

Patients receiving mechanical ventilation in the intensive care unit (ICU) frequently develop ICU-acquired weakness - a condition marked by widespread muscle loss and weakness caused by prolonged bed rest, severe illness, and systemic inflammation. This complication can lengthen time on the ventilator, extend ICU stays, and lead to lasting physical disability. Standard rehabilitation therapies in the ICU have limited ability to slow muscle loss because critically ill patients cannot tolerate high levels of exercise. Blood flow restriction training (BFRT) is a rehabilitation technique that uses an inflatable cuff on the upper leg to partially restrict blood flow during low-intensity exercise. This approach is known to stimulate muscle growth and preserve strength with much lower physical effort than traditional strength training, making it a promising option for vulnerable ICU patients. This randomized controlled trial is designed to test the safety and effectiveness of BFRT in mechanically ventilated adults with ICU-acquired weakness. A total of 120 eligible patients will be randomly divided into three groups: A control group receiving standard ICU medical care and routine rehabilitation A group receiving standard care plus BFRT at 40% of individual limb occlusion pressure A group receiving standard care plus BFRT at 60% of individual limb occlusion pressure All patients will receive 2 weeks of intervention. The research team will measure and compare muscle strength, lower limb muscle size (via ultrasound), blood inflammatory markers, duration of mechanical ventilation, length of ICU stay, and ventilator weaning success rates across the three groups. This study aims to determine whether adding BFRT to standard rehabilitation can improve muscle function, reduce systemic inflammation, and shorten hospital recovery time for these patients, and which pressure level provides the optimal balance of benefits and safety.

Official title: Effects of Blood Flow Restriction Training at Different Limb Occlusion Pressures on Muscle Strength, Lower-Limb Muscle Morphology and Serum Inflammatory Factors in Mechanically Ventilated ICU-Acquired Weakness Patients: A Prospective Three-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09-15

Completion Date

2027-09-01

Last Updated

2026-09-03

Healthy Volunteers

Conditions

Intensive Care Unit Acquired Weakness

Interventions

OTHER

Blood flow restriction training

Blood flow restriction training (BFRT) is administered using a wireless automated pneumatic cuff system (BFR Cuffs 2.0) placed on the proximal thigh. Training pressure is individually calibrated as a percentage of each patient's resting limb occlusion pressure (LOP), measured via the device's built-in pressure sensor and algorithm to accommodate differences in limb circumference and vascular tone. The intervention partially restricts venous return while preserving arterial inflow, combining low-intensity lower-extremity resistance movements with localized hypoxic and metabolic stress to stimulate muscle anabolic pathways. It is delivered at very low perceived exertion (Borg RPE 9-11) with continuous bedside vital sign monitoring, specifically adapted for hemodynamically stable critically ill patients with ICU-acquired weakness.

OTHER

Standard ICU Care and Routine Rehabilitation

This arm serves as the control reference, delivering the standard-of-care clinical pathway for critically ill mechanically ventilated patients. It includes comprehensive ICU medical management (anti-infective treatment, ventilatory support, enteral nutrition, hemodynamic maintenance, electrolyte balance correction, and evidence-based nursing bundles) plus standardized early rehabilitation administered by certified therapists per institutional ICU rehabilitation protocols. No investigational blood flow restriction intervention is applied in this group; all care follows routine clinical practice without additional study-specific exercise modifications.

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.

Clinical Research Directory

Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness

Summary

Key Details

Conditions

Interventions

Eligibility Criteria