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

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.

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.

Sponsors & Collaborators

• Affiliated Hospital of Jining Medical University

  lead OTHER

Principal Investigators

• Xiang Li · Affiliated Hospital of Jining Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2027-05-01

Completion

2027-09-01